Latest Cancer TreatmentsDr. Mohammadreza Dabiri
Dr. Mohammadreza Dabiriفارسی
Cancer type

Lung cancer

The most common and deadliest cancer in the world, but with screening, targeted therapy and immunotherapy, more hopeful than ever

Updated: 21 October 20267 min read70 references
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Key points

  • In 2022, lung cancer was the most commonly diagnosed cancer and the leading cause of cancer death worldwide [1].
  • Smoking is the most important risk factor, and quitting is beneficial at any age [2].
  • Annual low-dose CT in people at high risk reduces deaths from lung cancer [3, 4].
  • Testing for genetic mutations in the tumor (such as EGFR and ALK) and for PD-L1 before starting treatment for advanced lung cancer is essential, because it completely changes the treatment [5, 27].
  • Immunotherapy before and after surgery, and targeted drugs after surgery, have improved survival in patients with early-stage disease [6, 7, 8].

What is lung cancer?

Lung cancer develops when the cells lining the airways or the lung tissue grow out of control. In 2022, nearly 2.5 million new cases of lung cancer were diagnosed worldwide (one in every eight cancers), and about 1.8 million people died of the disease [1].

Lung cancer is divided into two main groups [9]:

  • Non-small cell lung cancer (NSCLC): accounts for most lung cancers and includes adenocarcinoma, squamous cell carcinoma and large cell carcinoma. Many adenocarcinomas carry targetable genetic mutations.
  • Small cell lung cancer (SCLC): a more aggressive type that grows quickly, spreads early and is almost always linked to smoking.

Signs and symptoms

In its early stages, lung cancer often causes no symptoms, and many patients are diagnosed when the disease is already advanced; that is why screening people at high risk matters [2]. Symptoms that should be discussed with a doctor:

  • A new cough, or a change in a long-standing cough, that lasts more than three weeks
  • Coughing up blood
  • Shortness of breath or wheezing without a clear cause
  • Chest or shoulder pain
  • Unexplained weight loss and loss of appetite, severe fatigue
  • Repeated or prolonged chest infections
  • Hoarseness that does not go away

When should I see a doctor?

When should I see a doctor?

See a doctor if any of the symptoms above lasts more than a few weeks or if you cough up blood, especially if you smoke or have smoked in the past. Most coughs and breathlessness have simpler causes, such as an infection or asthma, and having symptoms does not mean you have cancer.

Risk factors and prevention

Smoking

The most important risk factor for lung cancer; the risk rises with the number of years and the amount smoked (pack-years) and falls as the years since quitting go by [2]. Water pipes (hookah), pipes and secondhand smoke are not safe either.

Radon gas

A radioactive, colorless and odorless gas that enters buildings from the soil and is a known risk factor for lung cancer, especially in non-smokers [9].

Air pollution and occupational exposure

Outdoor and indoor air pollution and occupational exposure to substances such as asbestos also increase the risk of lung cancer [9].

Family history and lung disease

A history of lung cancer in close relatives and some chronic lung diseases are associated with a higher risk. Increasing age is also a risk factor [2].

For patients
The best thing you can do

Quitting smoking is the most effective way to lower your risk of lung cancer, and it is never too late to quit. Ask your doctor about medicines and programs that help people stop smoking.

Screening with low-dose CT

In the large US NLST trial of more than 53,000 high-risk participants, three rounds of annual low-dose CT reduced lung cancer deaths by 20% compared with chest X-rays [3]. The European NELSON trial also showed that, in high-risk men, CT screening reduced the risk of death from lung cancer by about 24% after 10 years of follow-up (hazard ratio 0.76) [4].

On this basis, in 2021 the US Preventive Services Task Force (USPSTF) recommended that adults aged 50 to 80 with a smoking history of at least 20 pack-years who still smoke or have quit within the past 15 years be screened annually with low-dose CT [2].

What does “pack-year” mean?

The number of packs of cigarettes smoked per day multiplied by the number of years of smoking. For example, one pack a day for 20 years, or two packs a day for 10 years, equals 20 pack-years.

Weigh the benefits and harms of screening

A large proportion of positive findings on screening CT turn out not to be cancer; in NLST, more than 96% of positive results in the CT group were false positives [3]. The decision to be screened should therefore be made after talking with a doctor, at centers experienced in following up lung nodules.

Diagnosis and staging

Diagnostic pathway for lung cancer

  1. 1

    Imaging

    Contrast-enhanced CT of the chest; if cancer is suspected, PET-CT to assess the extent of the disease and brain MRI when needed.

  2. 2

    Biopsy

    By bronchoscopy, endobronchial ultrasound (EBUS) or CT-guided needle biopsy; the only definitive way to diagnose the cancer and determine its type.

  3. 3

    Molecular testing and PD-L1

    In advanced non-small cell lung cancer (especially adenocarcinoma), targetable alterations such as EGFR, ALK, ROS1, BRAF, KRAS, MET, RET, NTRK and HER2 should be tested, preferably by next-generation sequencing (NGS) [5]. In early-stage disease, EGFR and ALK testing is also needed to decide on treatment after surgery [6, 10, 28].

  4. 4

    TNM staging

    Determining tumor size (T), lymph node involvement (N) and distant metastasis (M); sometimes sampling of the mediastinal lymph nodes is needed for accurate staging.

  5. 5

    Assessment of lung function and general condition

    Breathing and heart tests to determine whether the patient can tolerate surgery or radiotherapy, with the final decision made at a multidisciplinary tumor board.

Biomarkers and targeted therapy

In non-small cell lung cancer, the tumors of some patients grow because of one specific genetic change. Oral targeted drugs can block that change and are usually more effective and better tolerated than chemotherapy [5]. In patients without such a mutation, the level of PD-L1 expression helps guide the choice of immunotherapy [11].

Important biomarkers in advanced non-small cell lung cancer and the matching drugs
MarkerTargeted drugs / treatment
EGFR (exon 19 deletion or L858R)Osimertinib alone or with pemetrexed–platinum chemotherapy; another option: amivantamab + lazertinib [27]
ALK rearrangementAlectinib, lorlatinib or brigatinib; ensartinib [5, 27]
ROS1 rearrangementCrizotinib, entrectinib, repotrectinib, taletrectinib [5]
BRAF V600EDabrafenib + trametinib; the preferred first-line option in the guidelines [5, 27]
HER2 mutationTrastuzumab deruxtecan, an antibody–drug conjugate (ADC) [18]
KRAS G12CFirst line: immunotherapy with or without chemotherapy, as for patients without a driver mutation; thereafter: docetaxel, or the KRAS G12C inhibitors sotorasib or adagrasib [5]
MET exon 14 skipping mutationCrizotinib; capmatinib or tepotinib [5, 27, 31]
RET rearrangementPlatinum chemotherapy with or without pembrolizumab; the targeted drug selpercatinib is more effective and is the preferred option in the guidelines; pralsetinib [5, 30]
NTRK fusionLarotrectinib or entrectinib (recommended options in the guidelines) [5, 27]; otherwise, treatment as for patients without a driver mutation
PD-L1 ≥50% without a driver mutationPembrolizumab alone, or immunotherapy plus chemotherapy [11, 25, 35]
Non-squamous type without a driver mutation (any PD-L1 level)Pembrolizumab + pemetrexed + platinum [25]

The final choice of drug depends on the patient’s condition, the features of the tumor and the oncologist’s judgment.

Treatment by stage

Early-stage resectable disease (I to IIIA)

Surgery (usually lobectomy) is the foundation of treatment. In larger tumors or those with lymph node involvement, immunotherapy with nivolumab or pembrolizumab plus chemotherapy before surgery (and, in the pembrolizumab regimen, also after surgery) has improved survival [7, 8, 28]. If surgery was done first, pembrolizumab after adjuvant chemotherapy reduced the risk of recurrence [29]. In patients with an EGFR mutation, osimertinib after surgery [6], and in ALK rearrangement, alectinib after surgery compared with platinum chemotherapy [10], markedly reduce the risk of recurrence. The NCCN guideline recommends that patients with tumors of 4 cm or larger or with lymph node involvement be evaluated for treatment before surgery, with EGFR and ALK testing done beforehand [26, 28].

Unresectable stage III

Concurrent chemotherapy and radiotherapy is the foundation of treatment. Afterward, in patients with an EGFR mutation, osimertinib markedly reduces the risk of disease progression [20], and in other patients, one year of consolidation immunotherapy with durvalumab has improved overall survival [19, 28].

Stage IV (advanced)

If a targetable mutation is present, an oral targeted drug is the first choice [5]. Otherwise, immunotherapy with pembrolizumab, alone or with chemotherapy, is used according to PD-L1 and the histologic type of the tumor [11, 25]. Radiotherapy and supportive care play an important role in controlling symptoms.

Small cell lung cancer

In limited-stage disease: concurrent chemoradiotherapy is the foundation of treatment, and adding consolidation durvalumab afterward improved overall survival [21]. In extensive-stage disease: platinum–etoposide chemotherapy plus immunotherapy with atezolizumab [22] or durvalumab [33] for 4 cycles, followed by maintenance immunotherapy [22, 37]. After progression: if relapse occurs at least 3 months after the end of first-line treatment, re-treatment with carboplatin–etoposide is a suitable option [32]; otherwise, second-line chemotherapy such as topotecan is used. The newer drug tarlatamab provided longer survival than second-line chemotherapy [23].

For patients

What should I do after a diagnosis?

For patients
Slides1 / 5
1

You are not alone

Hearing that you have lung cancer is hard. Treatments for this disease have advanced greatly compared with a few years ago, and many patients, even at advanced stages, live for years with a good quality of life.

2

Know the type and stage of your cancer

Ask your doctor: Is my cancer small cell or non-small cell? What stage is it? Is surgery possible?

3

Ask about genetic testing of the tumor

In many patients, testing for gene changes such as EGFR mutations or ALK rearrangements can open the door to targeted pills. Before starting treatment, ask: “Have molecular and PD-L1 tests been done on my tumor?”

4

Stop smoking now

Quitting smoking, even after a cancer diagnosis, helps improve the results of treatment, reduces complications from surgery and radiotherapy, and helps you feel better. Ask your treatment team for help.

5

Report side effects early

Immunotherapy and targeted drugs have their own side effects. Report a new cough or shortness of breath, diarrhea, skin rashes or severe fatigue to your treatment team right away; most side effects can be controlled if they are recognized early.

Frequently asked questions

Can people who have never smoked get lung cancer?

Yes. Smoking is the most important risk factor, but factors such as radon gas, air pollution and occupational exposure also play a role [9]. Lung cancer in non-smokers is often adenocarcinoma and is more likely to carry mutations that can be treated with targeted drugs.

Who should be screened?

According to the USPSTF recommendation, people aged 50 to 80 with a smoking history of at least 20 pack-years who still smoke or have quit within the past 15 years should have a low-dose CT scan every year [2]. A plain chest X-ray is not recommended for screening.

Does a biopsy make cancer spread?

No; this is a common misconception. A biopsy is essential for a definitive diagnosis and for identifying genetic mutations, and without it the best treatment cannot be chosen. Full answer (Persian)

How is immunotherapy different from chemotherapy?

Chemotherapy directly kills dividing cells, whereas immunotherapy releases the brakes on the immune system so that the body itself can fight the cancer. In some patients, the response to immunotherapy lasts a very long time [25]. Its side effects are different and can affect any organ, including the lungs, bowel, thyroid and skin. Full answer (Persian)

If I have an EGFR mutation or ALK rearrangement, do I need chemotherapy?

In advanced disease, the first treatment is usually an oral targeted drug; sometimes the doctor combines it with chemotherapy or another drug for a greater effect [13, 14]. The final decision depends on your situation and the oncologist’s judgment.

For physicians

Evidence and recent advances (for physicians)

For physicians4 key findings · Early-stage disease · +2 more
For physicians
31.9% vs 16.3%
5-year overall survival with pembrolizumab monotherapy vs chemotherapy (PD-L1 ≥50%)
Median 26.3 vs 13.4 months; KEYNOTE-024 [11]
53.6 vs 42.0 months
Median disease-free survival with adjuvant pembrolizumab vs placebo
HR 0.76; PEARLS/KEYNOTE-091 [29]
4.7 vs 2.7 months
Median progression-free survival with carboplatin–etoposide rechallenge vs oral topotecan (SCLC with sensitive relapse)
HR 0.57; phase 3 trial [32]
24.8 vs 11.2 months
Median progression-free survival with selpercatinib vs platinum chemotherapy with or without pembrolizumab (RET-positive)
HR 0.46; LIBRETTO-431 [30]
For physicians

Early-stage disease

In ADAURA, adjuvant osimertinib (for up to 3 years) in resected EGFR-mutant stage IB–IIIA NSCLC significantly improved not only DFS but also overall survival (5-year survival in stage II–IIIA: 85% vs 73%, HR for death 0.49; in the overall IB–IIIA population: 88% vs 78%, HR for death 0.49) [6]. In ALINA, adjuvant alectinib for 24 months, compared with platinum chemotherapy, increased 2-year disease-free survival in stage II–IIIA to 93.8% vs 63.0% (HR 0.24) [10].

In the neoadjuvant approach, CheckMate 816, with three cycles of nivolumab plus chemotherapy, improved overall survival in the final analysis (5-year survival 65.4% vs 55.0%; HR 0.72); 5-year survival in patients with a pathologic complete response was 95.3% (exploratory analysis) [7]. In the perioperative approach, KEYNOTE-671 (pembrolizumab before and after surgery), at 5-year follow-up, increased event-free survival to 49.9% vs 26.5% (HR 0.58) and overall survival to 64.6% vs 53.6% (HR 0.74) [8]. In patients who have surgery first, adjuvant pembrolizumab in PEARLS/KEYNOTE-091 (up to 18 cycles, after adjuvant chemotherapy if indicated) increased median disease-free survival to 53.6 months vs 42.0 months with placebo (HR 0.76) [29].

Locally advanced disease

In the EGFR-mutant subgroup, osimertinib after chemoradiotherapy in LAURA increased median progression-free survival to 39.1 vs 5.6 months (HR 0.16) [20]. In other patients, consolidation durvalumab after concurrent chemoradiotherapy in PACIFIC resulted in an estimated 5-year survival of 42.9% vs 33.4% with placebo [19].

Oncogene-driven advanced disease

For EGFR, in addition to osimertinib monotherapy, which improved overall survival compared with older inhibitors [12], there are two intensified first-line strategies: osimertinib plus pemetrexed–platinum vs osimertinib monotherapy in FLAURA2 (HR for progression 0.62) [13], which in the final analysis also improved overall survival (median 47.5 vs 37.6 months; HR 0.77) at the cost of more grade ≥3 adverse events (70% vs 34%) [24]; and amivantamab (an EGFR–MET bispecific antibody) plus lazertinib vs osimertinib in MARIPOSA (median PFS 23.7 vs 16.6 months) [14], which in the final analysis also improved overall survival (HR 0.75; 3-year survival 60% vs 51%), albeit with more grade ≥3 adverse events (80% vs 52%), particularly skin toxicity, venous thromboembolism and infusion-related reactions [15]. The NCCN guideline considers all three strategies preferred category 1 options [27]. For ALK, at 5-year follow-up of CROWN with lorlatinib, 60% of patients were progression-free after 5 years, median PFS had not yet been reached, and the HR for time to intracranial progression was 0.06 [16]. The ASCO guideline recommends alectinib, brigatinib or lorlatinib [5], and all four drugs (including ensartinib) are preferred first-line options in the NCCN guideline [27].

For physicians
Other driver alterations: key evidence and guideline recommendations
MarkerEvidence and guideline recommendations
ROS1 rearrangementAll four drugs (crizotinib, entrectinib, repotrectinib and taletrectinib) are recommended in the ASCO guideline [5]; entrectinib, repotrectinib or taletrectinib may be better in the presence of brain metastases [27].
HER2 mutationIn DESTINY-Lung02, at a dose of 5.4 mg/kg, the objective response rate was 49.0% [18].
KRAS G12CThe ASCO guideline does not recommend KRAS G12C inhibitors in the first line and uses them after platinum chemotherapy and immunotherapy [5]; in the phase 3 CodeBreaK 200 trial, sotorasib increased median progression-free survival from 4.5 to 5.6 months compared with docetaxel (HR 0.66), with fewer severe adverse events [17].
MET exon 14 skipping mutationIn the MET cohort of the PROFILE 1001 study, crizotinib achieved an objective response rate of 32% and a median progression-free survival of 7.3 months in 65 evaluable patients [31]; the ASCO and NCCN guidelines consider capmatinib or tepotinib the preferred options [5, 27].
RET rearrangementIn the phase 3 LIBRETTO-431 trial, selpercatinib increased median progression-free survival from 11.2 to 24.8 months compared with platinum chemotherapy with or without pembrolizumab (HR 0.46) [30]; the ASCO guideline prefers selpercatinib [5].
For physicians

Advanced disease without a driver alteration

With PD-L1 ≥50%, in KEYNOTE-024, median overall survival was 26.3 months with pembrolizumab vs 13.4 months with chemotherapy, and 31.9% vs 16.3% of patients were alive after 5 years [11]. In metastatic non-squamous NSCLC without EGFR/ALK alterations, adding pembrolizumab to pemetrexed–platinum in KEYNOTE-189, with 5-year follow-up, improved overall survival (HR 0.60; 5-year survival 19.4% vs 11.3%), regardless of PD-L1 expression [25].

Small cell lung cancer

In limited-stage disease, ADRIATIC made consolidation durvalumab after chemoradiotherapy the new standard (median overall survival 55.9 vs 33.4 months; HR 0.73) [21]. In sensitive relapse (at least 90 days after the end of first-line treatment), carboplatin–etoposide rechallenge increased median progression-free survival from 2.7 to 4.7 months compared with oral topotecan in a phase 3 trial (HR 0.57) [32]. In the phase 3 DeLLphi-304 trial, tarlatamab, a bispecific T-cell engager targeting DLL3, improved overall survival compared with standard second-line chemotherapy (median 13.6 vs 8.3 months; HR 0.60) [23], and it is a preferred option after progression in the NCCN guideline [33].

For physicians

Treatment regimens and dosing (for physicians)

Treatment regimens and doses: index30 regimens
For physicians
Shared safety notes

These notes apply to all the regimens in this section that contain the drug concerned; the note of each regimen gives only the points specific to that regimen.

  • Before starting treatment: in advanced NSCLC, the results of testing for targetable alterations (preferably by NGS) and PD-L1 should be available [5, 27]. In resectable NSCLC, EGFR and ALK status should be determined before starting neoadjuvant treatment, because these patients are candidates for adjuvant targeted therapy [6, 10, 28].
  • Immunotherapy (nivolumab, pembrolizumab, durvalumab, atezolizumab): check liver enzymes, creatinine and thyroid function at the start of treatment and periodically during treatment, and monitor the patient for hyperglycemia and symptoms of diabetes [35, 36, 37, 59].
  • Pemetrexed: premedication: folic acid 400 to 1000 mcg orally daily from 7 days before the first dose until 21 days after the last dose; vitamin B12 1 mg IM one week before the first dose and then every 3 cycles; and dexamethasone 4 mg orally twice daily (the day before, the day of and the day after the infusion) [39]. Pemetrexed has no recommended dose for CrCl below 45 mL/min [39].
  • Cisplatin: hydration before the infusion (1 to 2 liters of fluid), with hydration and urine output maintained for 24 hours; do not give the next cycle until creatinine is below 1.5 mg/dL and platelets are ≥100,000 [64].
  • Paclitaxel: standard premedication (corticosteroid and antihistamine) as per its label.
For physiciansResectable NSCLC: treatment before or after surgery, 6 regimens · Unresectable stage III NSCLC: chemoradiotherapy and consolidation therapy, 3 regimens · +6 more
For physicians

Resectable NSCLC: treatment before or after surgery

Nivolumab + platinum doublet chemotherapy before surgery (CheckMate 816)

Resectable NSCLC, stage IB (tumor ≥4 cm) to IIIA (AJCC 7th edition), without an EGFR mutation or ALK rearrangement; ECOG 0–1Cycle length: Every 21 days

Resectable NSCLC, stage IB (tumor ≥4 cm) to IIIA (AJCC 7th edition), without an EGFR mutation or ALK rearrangement; ECOG 0–1

Before prescribing: Shared safety notes
DrugDoseRouteSchedule
Nivolumab360 mgIV (30 min)Day 1, before chemotherapy
Accompanying chemotherapy (one of the options)
Paclitaxel + carboplatin175 or 200 mg/m² + AUC 5 or 6IVDay 1 (any histology)
Pemetrexed + cisplatin500 + 75 mg/m²IVDay 1 (non-squamous only)
Gemcitabine + cisplatin1000 or 1250 + 75 mg/m²IVGemcitabine days 1 and 8, cisplatin day 1 (squamous only)
Cycle length
Every 21 days
Duration
3 cycles, then surgery

Dose source: FDA label for nivolumab (description of the CheckMate 816 trial) [36] and the trial publication [7]; days 1 and 8 for gemcitabine from the trial protocol [70].

Evidence: CheckMate 816 (2025)

Perioperative pembrolizumab (KEYNOTE-671)

Resectable NSCLC, stage II, IIIA or IIIB (N2) (AJCC 8th edition; tumor ≥4 cm or node-positive), regardless of PD-L1Cycle length: Every 21 days

Resectable NSCLC, stage II, IIIA or IIIB (N2) (AJCC 8th edition; tumor ≥4 cm or node-positive), regardless of PD-L1

Before prescribing: Shared safety notes
DrugDoseRouteSchedule
Neoadjuvant: up to 4 cycles of 21 days
Pembrolizumab200 mgIV (30 min)Day 1, before chemotherapy
Cisplatin75 mg/m²IVDay 1
Pemetrexed (non-squamous) or gemcitabine (squamous)500 mg/m² or 1000 mg/m²IVPemetrexed day 1; gemcitabine days 1 and 8
Adjuvant, after surgery
Pembrolizumab200 mg every 3 weeks (or 400 mg every 6 weeks)IVStart 4 to 12 weeks after surgery
Cycle length
Every 21 days
Duration
12 weeks before surgery, then 39 weeks (up to 13 cycles) after surgery

Dose source: FDA label for pembrolizumab (description of the KEYNOTE-671 trial) [35] and the trial publication [66]; surgery no later than 20 weeks after the first dose; pembrolizumab dose reduction is not permitted (only interruption or discontinuation) [66]; 5-year results [8].

Evidence: KEYNOTE-671 (2026), KEYNOTE-671 (2024)

Cisplatin-based adjuvant chemotherapy (JIPANG)

Completely resected non-squamous NSCLC, pathologic stage II–IIIA (7th edition)Cycle length: Every 3 weeks

Completely resected non-squamous NSCLC, pathologic stage II–IIIA (7th edition)

Before prescribing: Shared safety notes
DrugDoseRouteSchedule
Option A
Pemetrexed + cisplatin500 + 75 mg/m²IVDay 1
Option B
Vinorelbine25 mg/m²IVDays 1 and 8
Cisplatin80 mg/m²IVDay 1
Cycle length
Every 3 weeks
Duration
4 cycles

In JIPANG (804 patients), median recurrence-free survival was 38.9 months with pemetrexed–cisplatin and 37.3 months with vinorelbine–cisplatin (HR 0.98), but febrile neutropenia (0.3% vs 11.6%) and grade 3–4 neutropenia (22.7% vs 81.1%) were less frequent with pemetrexed [67]. After chemotherapy, adjuvant pembrolizumab is considered for stage IB (≥4 cm) to IIIA, and adjuvant targeted therapy for EGFR mutations or ALK rearrangements (regimens below).

Adjuvant pembrolizumab (PEARLS/KEYNOTE-091)

After complete resection and platinum-based adjuvant chemotherapy; NSCLC stage IB (T2a ≥4 cm), II or IIIA

After complete resection and platinum-based adjuvant chemotherapy; NSCLC stage IB (T2a ≥4 cm), II or IIIA

Before prescribing: Shared safety notes
DrugDoseRouteSchedule
Pembrolizumab200 mg every 3 weeks or 400 mg every 6 weeksIV (30 min)Day 1
Cycle length
Every 21 days (or every 42 days)
Duration
Up to 12 months, or until recurrence or intolerable toxicity

Source of dose and indication: FDA label for pembrolizumab [35]; trial [29]. In KEYNOTE-091, pneumonitis occurred in 7% of patients (grade 3 in 1%) [35].

Adjuvant osimertinib (ADAURA)

Resected stage IB–IIIA NSCLC with an EGFR exon 19 deletion or L858R mutationCycle length: Continuous

Resected stage IB–IIIA NSCLC with an EGFR exon 19 deletion or L858R mutation

Before prescribing: Shared safety notes
DrugDoseRouteSchedule
Osimertinib80 mgOral, with or without foodOnce daily, continuous
Cycle length
Continuous
Duration
3 years in total, or until recurrence or intolerable toxicity

Source: FDA label for osimertinib [34]; trial [6]. Before starting: CBC and, in patients with cardiac risk factors, LVEF. QTc greater than 500 ms on two ECGs: withhold until below 481, then resume at 40 mg. Interstitial lung disease of any grade (without recent chemoradiotherapy): discontinue permanently. If a strong CYP3A4 inducer cannot be avoided, increase the dose to 160 mg daily [34].

Evidence: ADAURA (2023)

Adjuvant alectinib (ALINA)

Resected ALK-positive NSCLC (tumor ≥4 cm or node-positive)Cycle length: Continuous

Resected ALK-positive NSCLC (tumor ≥4 cm or node-positive)

Before prescribing: Shared safety notes
DrugDoseRouteSchedule
Alectinib600 mgOral, with foodTwice daily, continuous
Cycle length
Continuous
Duration
2 years in total, or until recurrence or intolerable toxicity

Source: FDA label for alectinib [38]; trial (vs platinum chemotherapy) [10]. Liver tests every 2 weeks for the first 3 months and monthly thereafter; CPK every 2 weeks during the first month; monitor heart rate (bradycardia) [38].

Evidence: ALINA (2024)

Doses follow the trial protocol, guideline or official drug label (source given in the notes of each regimen). Before prescribing, check blood counts, renal and hepatic function, drug interactions and the patient’s condition, and adjust the dose according to the drug label.

For physicians

Unresectable stage III NSCLC: chemoradiotherapy and consolidation therapy

Concurrent chemoradiotherapy: carboplatin + weekly paclitaxel (RTOG 0617)

Unresectable stage III NSCLC; performance status 0–1 and adequate lung functionEach drug’s schedule in the table

Unresectable stage III NSCLC; performance status 0–1 and adequate lung function

Before prescribing: Shared safety notes
DrugDoseRouteSchedule
Paclitaxel45 mg/m²IVWeekly, concurrent with radiotherapy
CarboplatinAUC 2IVWeekly, concurrent with radiotherapy
Radiotherapy60 Gy (2 Gy per fraction)IMRT or three-dimensional conformalDaily
Cycle schedule
Paclitaxel and carboplatin weekly; radiotherapy daily
Duration
Throughout the course of radiotherapy

In RTOG 0617, a dose of 74 Gy was not only not superior but was associated with shorter survival (median overall survival 20.3 vs 28.7 months; HR 1.38); in this trial, 2 consolidation cycles of paclitaxel 200 mg/m² + carboplatin AUC 6 were also given after chemoradiotherapy [65]. PACIFIC enrolled patients who had completed at least 2 cycles of platinum chemotherapy concurrent with radiotherapy, and durvalumab was started within 42 days thereafter [37].

Consolidation durvalumab after chemoradiotherapy (PACIFIC)

Unresectable stage III NSCLC without progression after at least 2 cycles of platinum chemotherapy concurrent with radiotherapy; WHO PS 0–1; with an EGFR mutation, osimertinib (next regimen) is preferredCycle length: Every 14 or 28 days

Unresectable stage III NSCLC without progression after at least 2 cycles of platinum chemotherapy concurrent with radiotherapy; WHO PS 0–1; with an EGFR mutation, osimertinib (next regimen) is preferred [20]

Before prescribing: Shared safety notes
DrugDoseRouteSchedule
Durvalumab10 mg/kg every 2 weeks or 1500 mg every 4 weeks (body weight ≥30 kg)IV (60 min)Start within 42 days after the end of chemoradiotherapy
Cycle length
Every 14 or 28 days
Duration
Up to 12 months, or until progression or intolerable toxicity

Source: FDA label for durvalumab [37]; 5-year results [19]. In PACIFIC, pneumonitis (including radiation pneumonitis) occurred in 18.3% of the durvalumab group vs 12.8% of the placebo group [37].

Evidence: LAURA (2024), PACIFIC (2022)

Osimertinib after chemoradiotherapy (LAURA)

Unresectable stage III NSCLC with an EGFR exon 19 deletion or L858R, without progression after concurrent or sequential platinum-based chemoradiotherapyCycle length: Continuous

Unresectable stage III NSCLC with an EGFR exon 19 deletion or L858R, without progression after concurrent or sequential platinum-based chemoradiotherapy

Before prescribing: Shared safety notes
DrugDoseRouteSchedule
Osimertinib80 mgOral, with or without foodOnce daily, continuous
Cycle length
Continuous
Duration
Until disease progression or intolerable toxicity

Source: FDA label for osimertinib [34]; trial [20]. In LAURA, pneumonitis (including radiation pneumonitis) occurred in 56% of the osimertinib group vs 38% of the placebo group (grade 3: 3.5%). After recent chemoradiotherapy: grade 1 pneumonitis → continue or withhold according to the clinical situation; grade 2 or higher → discontinue permanently [34].

Evidence: LAURA (2024)

Before prescribing, check each dose against the drug label, laboratory tests and the patient’s condition.

For physicians

Advanced NSCLC with an EGFR mutation or ALK rearrangement

Osimertinib monotherapy (FLAURA)

Metastatic NSCLC with an EGFR exon 19 deletion or L858R (tissue or plasma sample); first-line. Also the T790M mutation after older-generation inhibitorsCycle length: Continuous

Metastatic NSCLC with an EGFR exon 19 deletion or L858R (tissue or plasma sample); first-line. Also the T790M mutation after older-generation inhibitors

Before prescribing: Shared safety notes
DrugDoseRouteSchedule
Osimertinib80 mgOral, with or without food (can be dispersed in water)Once daily, continuous
Cycle length
Continuous
Duration
Until disease progression or intolerable toxicity

Source: FDA label [34]; trial [12]. Monitoring and dose modifications as for the adjuvant osimertinib regimen (ADAURA) (QTc, LVEF in patients with cardiac risk factors, permanent discontinuation for interstitial lung disease, 160 mg with a strong CYP3A4 inducer) [34].

Evidence: FLAURA (2020), FLAURA (2018), FLAURA (2018)

Osimertinib + pemetrexed + platinum (FLAURA2)

Locally advanced or metastatic NSCLC with an EGFR exon 19 deletion or L858R; first-lineEach drug’s schedule in the table

Locally advanced or metastatic NSCLC with an EGFR exon 19 deletion or L858R; first-line

Before prescribing: Shared safety notes
DrugDoseRouteSchedule
Induction: 4 cycles of 21 days
Osimertinib80 mgOralOnce daily, continuous
Pemetrexed500 mg/m²IV (10 min)Day 1, every 21 days
Cisplatin or carboplatin75 mg/m² or AUC 5IVDay 1, every 21 days
Maintenance
Osimertinib80 mgOralOnce daily
Pemetrexed500 mg/m²IVEvery 3 weeks
Cycle schedule
Pemetrexed (and platinum during the 4 induction cycles) every 21 days; osimertinib daily and continuously
Duration
4 induction cycles, then maintenance until progression or intolerable toxicity

Source: FDA label for osimertinib (description of the FLAURA2 trial) [34]; overall survival [24]. With this combination, assess LVEF before starting in all patients; interstitial lung disease occurred in 3.3% [34].

Evidence: FLAURA2 (2026), FLAURA2 (2023)

Amivantamab + lazertinib (MARIPOSA)

Locally advanced or metastatic NSCLC with an EGFR exon 19 deletion or L858R; first-lineEach drug’s schedule in the table

Locally advanced or metastatic NSCLC with an EGFR exon 19 deletion or L858R; first-line

Before prescribing: Shared safety notes
DrugDoseRouteSchedule
Lazertinib240 mgOral, with or without foodOnce daily, continuous (on infusion days, before amivantamab)
Amivantamab1050 mg (body weight less than 80 kg) or 1400 mg (≥80 kg)IV (via a peripheral vein in weeks 1 and 2)Weekly in weeks 1 to 5 (week 1 dose split: 350 mg on day 1 and the remainder on day 2); no dose in week 6; then every 2 weeks from week 7
Cycle schedule
Amivantamab weekly (5 doses), then every 2 weeks; lazertinib daily and continuously
Duration
Until disease progression or intolerable toxicity

Source: FDA labels for amivantamab and lazertinib [40, 41]; trial [14, 15]. Premedication (infusion-related reactions): dexamethasone 8 mg orally twice daily on days −2 and −1, and one dose 1 hour before the infusion on day 1; dexamethasone 20 mg IV on day 1 and dexamethasone 10 mg IV on day 2; with all infusions, diphenhydramine 25–50 mg and acetaminophen 650–1000 mg. Thromboembolism prophylaxis: prophylactic anticoagulation for the first 4 months. Skin prophylaxis: doxycycline or minocycline 100 mg twice daily from day 1 for 12 weeks, then clindamycin 1% lotion on the scalp for 9 months; a non-comedogenic moisturizer, washing hands and feet with 4% chlorhexidine, and sun protection [40].

Evidence: MARIPOSA (2025), MARIPOSA (2024)

ALK inhibitors (a single drug)

Metastatic ALK-positive NSCLC; first-lineCycle length: Continuous

Metastatic ALK-positive NSCLC; first-line

Before prescribing: Shared safety notes
DrugDoseRouteSchedule
One of the following drugs, continuous
Alectinib600 mgOral, with foodTwice daily
Lorlatinib100 mgOral, with or without foodOnce daily
Brigatinib90 mg for 7 days, then 180 mgOral, with or without foodOnce daily
Ensartinib225 mgOral, with or without foodOnce daily
Cycle length
Continuous
Duration
Until disease progression or intolerable toxicity

Sources: FDA labels [38, 42, 43, 44]; CROWN [16]. Alectinib: liver tests every 2 weeks for the first 3 months, CPK every 2 weeks during the first month, monitoring for bradycardia. Lorlatinib: cholesterol and triglycerides before starting and at months 1 and 2; monitor for neuropsychiatric effects, atrioventricular block and blood pressure; CrCl 15 to below 30: 75 mg; severe hepatic impairment (Child-Pugh C): 50 mg; concomitant use of a strong CYP3A inducer carries a risk of severe hepatotoxicity. Brigatinib: monitor respiratory symptoms, especially during the first week (the reason for the 90-mg starting dose); if treatment is interrupted for ≥14 days, restart at 90 mg for 7 days. Ensartinib: liver tests and fasting glucose before starting.

Evidence: CROWN (2024)

Before prescribing, check each dose against the drug label, laboratory tests and the patient’s condition.

For physicians

Advanced NSCLC with other driver alterations (ROS1, BRAF, MET, RET, NTRK)

ROS1 inhibitors (a single drug)

Locally advanced or metastatic NSCLC with a ROS1 rearrangementCycle length: Continuous

Locally advanced or metastatic NSCLC with a ROS1 rearrangement

Before prescribing: Shared safety notes
DrugDoseRouteSchedule
One of the following drugs, continuous
Crizotinib250 mgOralTwice daily
Entrectinib600 mgOral, with or without foodOnce daily
Repotrectinib160 mg once daily for 14 days, then 160 mg twice dailyOral, with or without foodContinuous
Taletrectinib600 mgOral, on an empty stomach (no food for 2 hours before and after)Once daily
Cycle length
Continuous
Duration
Until disease progression or intolerable toxicity

Sources: FDA labels [45, 46, 47, 48]; guidelines [5, 27]. Crizotinib: liver tests every 2 weeks for the first 2 months and monthly thereafter; monitor QTc, bradycardia and visual disturbances. Entrectinib: LVEF, uric acid, QTc and electrolytes before starting (risk of heart failure). Taletrectinib: liver tests, electrolytes, ECG and uric acid before starting. Repotrectinib: neurologic adverse effects (dizziness, ataxia) are common.

Dabrafenib + trametinib

Metastatic NSCLC with a BRAF V600E mutationCycle length: Continuous

Metastatic NSCLC with a BRAF V600E mutation

Before prescribing: Shared safety notes
DrugDoseRouteSchedule
Dabrafenib150 mgOral, 1 hour before or 2 hours after a mealTwice daily
Trametinib2 mgOralOnce daily
Cycle length
Continuous
Duration
Until disease progression or intolerable toxicity

Sources: FDA labels [49, 50]. Fever is common: for a fever of 38 to 40 °C, withhold dabrafenib until the fever resolves, then resume at the same or a lower dose [49]. LVEF before starting and during treatment; a decrease of ≥10% to below the normal range → withhold trametinib [50].

MET inhibitors (a single drug)

Metastatic NSCLC with a MET exon 14 skipping mutationCycle length: Continuous

Metastatic NSCLC with a MET exon 14 skipping mutation

Before prescribing: Shared safety notes
DrugDoseRouteSchedule
One of the following drugs, continuous
Crizotinib250 mgOralTwice daily (continuous 28-day cycles in PROFILE 1001)
Capmatinib400 mgOral, with or without foodTwice daily
Tepotinib450 mgOral, with foodOnce daily
Cycle length
Continuous
Duration
Until disease progression or intolerable toxicity

Sources: FDA labels for capmatinib and tepotinib [54, 55]; crizotinib dose from the MET cohort of the PROFILE 1001 study [31] (this indication is not in the FDA label for crizotinib). Monitor liver tests, amylase and lipase, and symptoms of interstitial lung disease [54, 55].

Selective RET inhibitors (a single drug)

Locally advanced or metastatic NSCLC with a RET gene fusionCycle length: Continuous

Locally advanced or metastatic NSCLC with a RET gene fusion

Before prescribing: Shared safety notes
DrugDoseRouteSchedule
One of the following drugs, continuous
Selpercatinib120 mg (body weight less than 50 kg) or 160 mg (≥50 kg)OralTwice daily
Pralsetinib400 mgOral, on an empty stomach (no food for 2 hours before and 1 hour after)Once daily
Cycle length
Continuous
Duration
Until disease progression or intolerable toxicity

Sources: FDA labels [56, 57]; LIBRETTO-431 [30]. Selpercatinib: ALT/AST before starting, every 2 weeks for the first 3 months and monthly thereafter; monitor blood pressure and QTc; avoid PPIs, H2 antihistamines and antacids (if unavoidable: with a PPI, take with food; take 2 hours before or 10 hours after an H2 blocker) [56]. Pralsetinib: risk of serious infections and interstitial lung disease; monitor blood pressure and liver tests [57].

TRK inhibitors (a single drug)

Advanced solid tumors (including NSCLC) with an NTRK gene fusionCycle length: Continuous

Advanced solid tumors (including NSCLC) with an NTRK gene fusion

Before prescribing: Shared safety notes
DrugDoseRouteSchedule
One of the following drugs, continuous
Larotrectinib100 mgOral, with or without foodTwice daily
Entrectinib600 mgOral, with or without foodOnce daily
Cycle length
Continuous
Duration
Until disease progression or intolerable toxicity

Sources: FDA labels [58, 46]. Monitor for neurologic adverse effects, liver tests and fracture risk [58].

Before prescribing, check each dose against the drug label, laboratory tests and the patient’s condition.

For physicians

Advanced NSCLC without a driver alteration: first-line

Pembrolizumab monotherapy (KEYNOTE-024)

Metastatic NSCLC with PD-L1 TPS ≥50%, without EGFR or ALK alterations; first-line; ECOG 0–1

Metastatic NSCLC with PD-L1 TPS ≥50%, without EGFR or ALK alterations; first-line; ECOG 0–1

Before prescribing: Shared safety notes
DrugDoseRouteSchedule
Pembrolizumab200 mg every 3 weeks or 400 mg every 6 weeksIV (30 min)Day 1
Cycle length
Every 21 days (or every 42 days)
Duration
Until progression, intolerable toxicity or a maximum of 24 months (35 three-weekly cycles in KEYNOTE-024)

Source: FDA label [35]; 5-year results [11].

Evidence: KEYNOTE-024 (2016)

Pembrolizumab + pemetrexed + platinum (KEYNOTE-189)

Metastatic non-squamous NSCLC without EGFR or ALK alterations, any PD-L1 level; first-lineCycle length: Every 21 days

Metastatic non-squamous NSCLC without EGFR or ALK alterations, any PD-L1 level; first-line

Before prescribing: Shared safety notes
DrugDoseRouteSchedule
Induction: 4 cycles of 21 days
Pembrolizumab200 mgIV (30 min)Day 1 (first)
Pemetrexed500 mg/m²IV (10 min)Day 1 (after pembrolizumab)
Cisplatin or carboplatin75 mg/m² or AUC 5IVDay 1 (last)
Maintenance
Pembrolizumab + pemetrexed200 mg + 500 mg/m²IVEvery 3 weeks
Cycle length
Every 21 days
Duration
Pembrolizumab for a maximum of 24 months (35 cycles); pemetrexed until progression or intolerable toxicity

Sources: FDA labels for pembrolizumab and pemetrexed [35, 39]; 5-year results [25].

Evidence: KEYNOTE-189 (2023)

Pembrolizumab + carboplatin + paclitaxel or nab-paclitaxel (KEYNOTE-407)

Metastatic squamous NSCLC, any PD-L1 level; first-lineCycle length: Every 21 days

Metastatic squamous NSCLC, any PD-L1 level; first-line

Before prescribing: Shared safety notes
DrugDoseRouteSchedule
Induction: 4 cycles of 21 days
Pembrolizumab200 mgIV (30 min)Day 1 (before chemotherapy)
CarboplatinAUC 6IVDay 1
Paclitaxel or nab-paclitaxel200 mg/m² or 100 mg/m²IVPaclitaxel day 1; nab-paclitaxel days 1, 8 and 15
Maintenance
Pembrolizumab200 mgIVEvery 3 weeks
Cycle length
Every 21 days
Duration
Pembrolizumab until progression, intolerable toxicity or a maximum of 24 months

Source: FDA label for pembrolizumab (description of the KEYNOTE-407 trial) [35].

Before prescribing, check each dose against the drug label, laboratory tests and the patient’s condition.

For physicians

Advanced NSCLC: later lines

Single-agent docetaxel (later line)

Advanced NSCLC after failure of platinum chemotherapy (and immunotherapy)Cycle length: Every 21 days

Advanced NSCLC after failure of platinum chemotherapy (and immunotherapy)

Before prescribing: Shared safety notes
DrugDoseRouteSchedule
Docetaxel75 mg/m²IV (1 h)Day 1
Cycle length
Every 21 days
Duration
Until disease progression or intolerable toxicity

Source: FDA label for docetaxel [63]. Premedication: dexamethasone 8 mg orally twice daily for 3 days, starting one day before the infusion. Do not give with neutrophils below 1500; avoid use if bilirubin is above the upper limit of normal, or if AST/ALT is more than 1.5 times with alkaline phosphatase more than 2.5 times the upper limit of normal (risk of treatment-related death) [63].

Trastuzumab deruxtecan (DESTINY-Lung02)

Metastatic NSCLC with an activating HER2 (ERBB2) mutation after prior systemic therapyCycle length: Every 21 days

Metastatic NSCLC with an activating HER2 (ERBB2) mutation after prior systemic therapy

Before prescribing: Shared safety notes
DrugDoseRouteSchedule
Trastuzumab deruxtecan5.4 mg/kgIV (first infusion over 90 min, then 30 min)Day 1
Cycle length
Every 21 days
Duration
Until disease progression or intolerable toxicity

Source: FDA label [51]; trial [18]. Not interchangeable with trastuzumab or T-DM1. Premedication to prevent nausea and vomiting. Grade 2 or higher interstitial lung disease → discontinue permanently (it occurred in 12.9% at the 5.4 dose in DESTINY-Lung02 [18]); CBC before each dose and LVEF monitoring [51].

KRAS G12C inhibitors (a single drug)

Locally advanced or metastatic NSCLC with a KRAS G12C mutation after at least one systemic therapy (usually platinum and immunotherapy)Cycle length: Continuous

Locally advanced or metastatic NSCLC with a KRAS G12C mutation after at least one systemic therapy (usually platinum and immunotherapy)

Before prescribing: Shared safety notes
DrugDoseRouteSchedule
One of the following drugs, continuous
Sotorasib960 mgOral, with or without foodOnce daily
Adagrasib600 mgOral, with or without foodTwice daily
Cycle length
Continuous
Duration
Until disease progression or intolerable toxicity

Sources: FDA labels [52, 53]; CodeBreaK 200 [17]. Sotorasib: liver tests every 3 weeks for the first 3 months and monthly thereafter [52]. Adagrasib: gastrointestinal adverse effects are common; monitor QTc and liver tests [53].

Before prescribing, check each dose against the drug label, laboratory tests and the patient’s condition.

For physicians

Small cell lung cancer: first-line

Concurrent chemoradiotherapy followed by durvalumab (ADRIATIC)

Limited-stage SCLC (stage I to III; stage I–II only if inoperable) without progression after concurrent chemoradiotherapy

Limited-stage SCLC (stage I to III; stage I–II only if inoperable) without progression after concurrent chemoradiotherapy

Before prescribing: Shared safety notes
DrugDoseRouteSchedule
Concurrent chemoradiotherapy: 4 cycles of 21 days
Cisplatin or carboplatin80 mg/m² or AUC 5IVDay 1
Etoposide100 mg/m²IVDays 1, 2 and 3
Thoracic radiotherapy45 Gy twice daily over 3 weeks, or 60 to 66 Gy once daily over 6 weeks—Concurrent with chemotherapy; starting on day 1 of cycle 1 or 2
Consolidation
Durvalumab1500 mg (body weight less than 30 kg: 20 mg/kg)IV (60 min)Every 4 weeks; start within 42 days after chemoradiotherapy
Cycle length
Chemotherapy every 21 days; durvalumab every 28 days
Duration
Durvalumab for a maximum of 24 months, or until progression or intolerable toxicity

Source: FDA label for durvalumab (description of the ADRIATIC trial) [37]; trial [21]. The dose and timing of the concurrent chemotherapy and the start of radiotherapy are from the CALGB 30610 trial [68]. Prophylactic cranial irradiation (PCI) after chemoradiotherapy was allowed at the physician’s discretion. Pneumonitis: 14% vs 6% with placebo [37].

Evidence: ADRIATIC (2024)

Atezolizumab + carboplatin + etoposide (IMpower133)

Extensive-stage SCLC, no prior chemotherapy; ECOG 0–1Cycle length: Every 21 days

Extensive-stage SCLC, no prior chemotherapy; ECOG 0–1

Before prescribing: Shared safety notes
DrugDoseRouteSchedule
Induction: 4 cycles of 21 days
Atezolizumab1200 mgIV (first infusion over 60 min, then 30 min)Day 1 (before chemotherapy)
CarboplatinAUC 5IVDay 1
Etoposide100 mg/m²IVDays 1, 2 and 3
Maintenance
Atezolizumab1200 mg every 3 weeks (or 840 mg every 2 weeks or 1680 mg every 4 weeks)IVDay 1
Cycle length
Every 21 days
Duration
4 induction cycles, then atezolizumab until progression or intolerable toxicity

Source: FDA label for atezolizumab [59]; trial [22].

Evidence: IMpower133 (2018)

Durvalumab + etoposide + platinum (CASPIAN)

Extensive-stage SCLC, no prior chemotherapy; WHO PS 0–1; asymptomatic or treated brain metastases allowed

Extensive-stage SCLC, no prior chemotherapy; WHO PS 0–1; asymptomatic or treated brain metastases allowed

Before prescribing: Shared safety notes
DrugDoseRouteSchedule
Induction: 4 cycles of 21 days
Durvalumab1500 mgIV (60 min)Day 1 (before chemotherapy)
Carboplatin or cisplatinAUC 5 or 6, or 75 to 80 mg/m²IVDay 1
Etoposide80 to 100 mg/m²IVDays 1, 2 and 3
Maintenance
Durvalumab1500 mgIVEvery 4 weeks
Cycle length
Every 21 days (maintenance every 28 days)
Duration
4 induction cycles, then durvalumab until progression or intolerable toxicity

Source: FDA label for durvalumab (description of the CASPIAN trial) [37]; guideline [33]. Body weight less than 30 kg: 20 mg/kg with chemotherapy, then 10 mg/kg every 2 weeks [37].

Evidence: CASPIAN (2019)

Before prescribing, check each dose against the drug label, laboratory tests and the patient’s condition.

For physicians

Small cell lung cancer: after progression

Carboplatin + etoposide rechallenge in sensitive relapse

Relapsed SCLC that responded to first-line platinum–etoposide and relapsed at least 90 days after its completion; ECOG 0–2Cycle length: Every 21 days

Relapsed SCLC that responded to first-line platinum–etoposide and relapsed at least 90 days after its completion; ECOG 0–2

Before prescribing: Shared safety notes
DrugDoseRouteSchedule
CarboplatinAUC 5IVDay 1
Etoposide100 mg/m²IVDays 1–3
Cycle length
Every 21 days
Duration
A maximum of 6 cycles

Dose source: phase 3 trial [32]; cycle length (every 3 weeks, maximum 6 cycles) from the trial registration on ClinicalTrials.gov (NCT02738346) [69].

Topotecan (second line)

SCLC after progression on first-line chemotherapyCycle length: Every 21 days

SCLC after progression on first-line chemotherapy

Before prescribing: Shared safety notes
DrugDoseRouteSchedule
One of two formulations
Intravenous topotecan1.5 mg/m²IV (30 min)Days 1–5
Oral topotecan2.3 mg/m² per dayOral, with or without foodDays 1–5
Cycle length
Every 21 days
Duration
Until disease progression or intolerable toxicity

Sources: FDA labels [61, 62]. Give the next cycle only with neutrophils above 1000, platelets above 100,000 and hemoglobin ≥9 g/dL. Intravenous: maximum 4 mg per dose; neutrophils below 500 or platelets below 25,000 → 1.25 mg/m² (or G-CSF); CrCl 20 to 39: 0.75 mg/m² [61]. Oral: CrCl 30 to 49: 1.5, and below 30: 0.6 mg/m² per day; grade 3–4 diarrhea → after recovery, reduce by 0.4 mg/m² [62].

Tarlatamab (DeLLphi-304)

Extensive-stage SCLC progressing on or after platinum-based chemotherapy

Extensive-stage SCLC progressing on or after platinum-based chemotherapy

Before prescribing: Shared safety notes
DrugDoseRouteSchedule
Cycle 1
Tarlatamab1 mg (step-up dose)IV (1 h)Cycle 1, day 1
Tarlatamab10 mgIV (1 h)Cycle 1, days 8 and 15
Cycle 2 onward
Tarlatamab10 mgIV (1 h)Days 1 and 15 of each cycle
Cycle length
Every 28 days (i.e., every 2 weeks)
Duration
Until disease progression or intolerable toxicity

Source: FDA label [60]; trial [23]. Boxed warning: cytokine release syndrome (CRS) and neurologic toxicity/ICANS. Premedication on cycle 1, days 1 and 8: dexamethasone 8 mg IV within 1 hour before the infusion, and 1 liter of normal saline IV over 2 to 4 hours immediately after the infusion; the patient should be well hydrated before the infusion. Monitoring: for 6 to 8 hours after the start of the infusion on cycle 1, days 1 and 8 (and cycle 1, day 15 and cycle 2), 3 to 4 hours in cycles 3 and 4, and 2 hours from cycle 5 onward; after the day 1 and day 8 doses, the patient should stay with a caregiver and within 1 hour of a treatment center for 48 hours. CBC and liver tests before each dose until cycle 5, day 15 [60].

Evidence: DeLLphi-304 (2025)

Before prescribing, check each dose against the drug label, laboratory tests and the patient’s condition.

Scientific evidence

Key studies

17 items
Clinical trial

Reduced Lung-Cancer Mortality with Low-Dose Computed Tomographic Screening

N Engl J Med · 2011
Summary
Clinical trial

Reduced Lung-Cancer Mortality with Volume CT Screening in a Randomized Trial

N Engl J Med · 2020
Summary
Clinical trial · Phase 3

Overall Survival with Osimertinib in Resected EGFR-Mutated NSCLC

N Engl J Med · 2023
Summary
Clinical trial · Phase 3

Overall Survival with Neoadjuvant Nivolumab plus Chemotherapy in Lung Cancer

N Engl J Med · 2025
Summary
Clinical trial · Phase 3

Five-Year Outcomes of Perioperative Pembrolizumab for Early-Stage Non-Small-Cell Lung Cancer From the Randomized KEYNOTE-671 Study

Ann Oncol · 2026
Summary
Clinical trial · Phase 3

Pembrolizumab Plus Pemetrexed and Platinum in Nonsquamous Non–Small-Cell Lung Cancer: 5-Year Outcomes From the Phase 3 KEYNOTE-189 Study

J Clin Oncol · 2023
Summary
Clinical trial · Phase 3

Osimertinib after Chemoradiotherapy in Stage III EGFR-Mutated NSCLC

N Engl J Med · 2024
Summary
Clinical trial · Phase 3

Survival with Osimertinib plus Chemotherapy in EGFR -Mutated Advanced NSCLC

N Engl J Med · 2026
Summary
Clinical trial · Phase 3

First-Line Atezolizumab plus Chemotherapy in Extensive-Stage Small-Cell Lung Cancer

N Engl J Med · 2018
Summary
Clinical trial · Phase 3

Alectinib in Resected ALK-Positive Non–Small-Cell Lung Cancer

N Engl J Med · 2024
Summary
Clinical trial · Phase 3

Lorlatinib Versus Crizotinib in Patients With Advanced ALK-Positive Non–Small Cell Lung Cancer: 5-Year Outcomes From the Phase III CROWN Study

J Clin Oncol · 2024
Summary
Clinical trial · Phase 3

Five-Year Survival Outcomes From the PACIFIC Trial: Durvalumab After Chemoradiotherapy in Stage III Non–Small-Cell Lung Cancer

J Clin Oncol · 2022
Summary
Clinical trial · Phase 3

Durvalumab after Chemoradiotherapy in Limited-Stage Small-Cell Lung Cancer

N Engl J Med · 2024
Summary
Clinical trial · Phase 3

Overall Survival with Amivantamab–Lazertinib in EGFR -Mutated Advanced NSCLC

N Engl J Med · 2025
Summary
Clinical trial · Phase 3

Tarlatamab in Small-Cell Lung Cancer after Platinum-Based Chemotherapy

N Engl J Med · 2025
Summary
Clinical trial · Phase 3

Osimertinib with or without Chemotherapy in EGFR-Mutated Advanced NSCLC

N Engl J Med · 2023
Summary
Clinical trial · Phase 3

Amivantamab plus Lazertinib in Previously Untreated EGFR-Mutated Advanced NSCLC

N Engl J Med · 2024
Summary

Clinical guidelines

3 items
Clinical guideline

NCCN Guidelines® Insights: Non-Small Cell Lung Cancer, Version 7.2025

J Natl Compr Canc Netw · 2025
Summary
Clinical guideline

Non-Small Cell Lung Cancer, Version 4.2026, NCCN Clinical Practice Guidelines In Oncology

J Natl Compr Canc Netw · 2026
Summary
Clinical guideline

Pan-Asian adapted ESMO Clinical Practice Guidelines for the diagnosis, treatment and follow-up of patients with oncogene-addicted metastatic non-small-cell lung cancer

ESMO Open · 2024
Summary

References

70 references
Show all references, 24 with a study cardClose the reference list

Numbers in the text, such as [1], refer to these sources. Sources with a “Study card” button are summarised in the site’s evidence library.

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    Global cancer statistics 2022: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countriesBray F, Laversanne M, Sung H, Ferlay J, Siegel RL, Soerjomataram I, et al · CA A Cancer J Clinicians · 2024;74:229-263
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    Screening for Lung CancerUS Preventive Services Task Force; Krist AH, Davidson KW, Mangione CM, Barry MJ, Cabana M, et al · JAMA · 2021;325:962
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    Reduced Lung-Cancer Mortality with Low-Dose Computed Tomographic ScreeningNational Lung Screening Trial Research Team; Aberle DR, Adams AM, Berg CD, Black WC, Clapp JD, Fagerstrom RM, et al · N Engl J Med · 2011;365:395-409
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    Reduced Lung-Cancer Mortality with Volume CT Screening in a Randomized Trialde Koning HJ, van der Aalst CM, de Jong PA, Scholten ET, Nackaerts K, Heuvelmans MA, et al · N Engl J Med · 2020;382:503-513
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    Therapy for Stage IV Non-Small Cell Lung Cancer With Driver Alterations: ASCO Living Guideline, 2026.3.0Puri S, Leighl NB, Ismaila N, Rous FA, Ahluwalia A, Alluri K, et al · J Clin Oncol · 2026;44:e15-e55
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    Overall Survival with Osimertinib in Resected EGFR-Mutated NSCLCTsuboi M, Herbst RS, John T, Kato T, Majem M, Grohé C, et al · N Engl J Med · 2023;389:137-147
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    Overall Survival with Neoadjuvant Nivolumab plus Chemotherapy in Lung CancerForde PM, Spicer JD, Provencio M, Mitsudomi T, Awad MM, Wang C, et al · N Engl J Med · 2025;393:741-752
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    Five-Year Outcomes of Perioperative Pembrolizumab for Early-Stage Non-Small-Cell Lung Cancer From the Randomized KEYNOTE-671 StudyWakelee H, Spicer JD, Gao S, Liberman M, Tsuboi M, Kato T, et al · Ann Oncol · 2026
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    Lung cancerThai AA, Solomon BJ, Sequist LV, Gainor JF, Heist RS · The Lancet · 2021;398:535-554
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    Alectinib in Resected ALK-Positive Non–Small-Cell Lung CancerWu YL, Dziadziuszko R, Ahn JS, Barlesi F, Nishio M, Lee DH, et al · N Engl J Med · 2024;390:1265-1276
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    Five-Year Outcomes With Pembrolizumab Versus Chemotherapy for Metastatic Non-Small-Cell Lung Cancer With PD-L1 Tumor Proportion Score ≥ 50%Reck M, Rodríguez-Abreu D, Robinson AG, Hui R, Csőszi T, Fülöp A, et al · J Clin Oncol · 2021;39:2339-2349
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    Overall Survival with Osimertinib in Untreated, EGFR-Mutated Advanced NSCLCRamalingam SS, Vansteenkiste J, Planchard D, Cho BC, Gray JE, Ohe Y, et al · N Engl J Med · 2020;382:41-50
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    Osimertinib with or without Chemotherapy in EGFR-Mutated Advanced NSCLCPlanchard D, Jänne PA, Cheng Y, Yang JCH, Yanagitani N, Kim SW, et al · N Engl J Med · 2023;389:1935-1948
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    Amivantamab plus Lazertinib in Previously Untreated EGFR-Mutated Advanced NSCLCCho BC, Lu S, Felip E, Spira AI, Girard N, Lee JS, et al · N Engl J Med · 2024;391:1486-1498
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    Overall Survival with Amivantamab–Lazertinib in EGFR-Mutated Advanced NSCLCYang JCH, Lu S, Hayashi H, Felip E, Spira AI, Girard N, et al · N Engl J Med · 2025;393:1681-1693
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    Lorlatinib Versus Crizotinib in Patients With Advanced ALK-Positive Non–Small Cell Lung Cancer: 5-Year Outcomes From the Phase III CROWN StudySolomon BJ, Liu G, Felip E, Mok TSK, Soo RA, Mazieres J, et al · JCO · 2024;42:3400-3409
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    Sotorasib versus docetaxel for previously treated non-small-cell lung cancer with KRASG12C mutation: a randomised, open-label, phase 3 trialde Langen AJ, Johnson ML, Mazieres J, Dingemans AC, Mountzios G, Pless M, et al · Lancet · 2023;401:733-746
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    Trastuzumab Deruxtecan in Patients With HER2-Mutant Metastatic Non-Small-Cell Lung Cancer: Primary Results From the Randomized, Phase II DESTINY-Lung02 TrialGoto K, Goto Y, Kubo T, Ninomiya K, Kim SW, Planchard D, et al · J Clin Oncol · 2023;41:4852-4863
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    Five-Year Survival Outcomes From the PACIFIC Trial: Durvalumab After Chemoradiotherapy in Stage III Non–Small-Cell Lung CancerSpigel DR, Faivre-Finn C, Gray JE, Vicente D, Planchard D, Paz-Ares L, et al · JCO · 2022;40:1301-1311
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    Osimertinib after Chemoradiotherapy in Stage III EGFR-Mutated NSCLCLu S, Kato T, Dong X, Ahn MJ, Quang LV, Soparattanapaisarn N, et al · N Engl J Med · 2024;391:585-597
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    Durvalumab after Chemoradiotherapy in Limited-Stage Small-Cell Lung CancerCheng Y, Spigel DR, Cho BC, Laktionov KK, Fang J, Chen Y, et al · N Engl J Med · 2024;391:1313-1327
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    Pembrolizumab Plus Pemetrexed and Platinum in Nonsquamous Non–Small-Cell Lung Cancer: 5-Year Outcomes From the Phase 3 KEYNOTE-189 StudyGarassino MC, Gadgeel S, Speranza G, Felip E, Esteban E, Dómine M, et al · J Clin Oncol · 2023;41:1992-1998
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    Pembrolizumab versus placebo as adjuvant therapy for completely resected stage IB-IIIA non-small-cell lung cancer (PEARLS/KEYNOTE-091): an interim analysis of a randomised, triple-blind, phase 3 trialO'Brien M, Paz-Ares L, Marreaud S, Dafni U, Oselin K, Havel L, et al · Lancet Oncol · 2022;23:1274-1286
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    First-Line Selpercatinib or Chemotherapy and Pembrolizumab in RET Fusion-Positive NSCLCZhou C, Solomon B, Loong HH, Park K, Pérol M, Arriola E, et al · N Engl J Med · 2023;389:1839-1850
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    Antitumor activity of crizotinib in lung cancers harboring a MET exon 14 alterationDrilon A, Clark JW, Weiss J, Ou SI, Camidge DR, Solomon BJ, et al · Nat Med · 2020;26:47-51
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    Carboplatin plus etoposide versus topotecan as second-line treatment for patients with sensitive relapsed small-cell lung cancer: an open-label, multicentre, randomised, phase 3 trialBaize N, Monnet I, Greillier L, Geier M, Lena H, Janicot H, et al · Lancet Oncol · 2020;21:1224-1233
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    IMFINZI (durvalumab) injection, for intravenous use: Prescribing InformationAstraZeneca Pharmaceuticals LP · DailyMed, U.S. National Library of Medicine · 2026
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    ALECENSA (alectinib) capsules, for oral use: Prescribing InformationGenentech, Inc · DailyMed, U.S. National Library of Medicine · 2026
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    ALIMTA (pemetrexed) for injection, for intravenous use: Prescribing InformationEli Lilly and Company · DailyMed, U.S. National Library of Medicine · 2023
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    RYBREVANT (amivantamab-vmjw) injection, for intravenous use: Prescribing InformationJanssen Biotech, Inc · DailyMed, U.S. National Library of Medicine · 2025
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    LAZCLUZE (lazertinib) tablets, for oral use: Prescribing InformationJanssen Biotech, Inc · DailyMed, U.S. National Library of Medicine · 2026
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    LORBRENA (lorlatinib) tablets, for oral use: Prescribing InformationPfizer Laboratories Div Pfizer Inc · DailyMed, U.S. National Library of Medicine · 2026
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    ALUNBRIG (brigatinib) tablets, for oral use: Prescribing InformationTakeda Pharmaceuticals America, Inc · DailyMed, U.S. National Library of Medicine · 2026
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    ENSACOVE (ensartinib) capsules, for oral use: Prescribing InformationXcovery Holdings, Inc · DailyMed, U.S. National Library of Medicine · 2026
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    XALKORI (crizotinib) capsules / oral pellets: Prescribing InformationPfizer Laboratories Div Pfizer Inc · DailyMed, U.S. National Library of Medicine · 2025
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    ROZLYTREK (entrectinib) capsules / oral pellets: Prescribing InformationGenentech, Inc · DailyMed, U.S. National Library of Medicine · 2026
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    AUGTYRO (repotrectinib) capsules, for oral use: Prescribing InformationE.R. Squibb & Sons, L.L.C · DailyMed, U.S. National Library of Medicine · 2024
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    IBTROZI (taletrectinib) capsules, for oral use: Prescribing InformationNuvation Bio Inc · DailyMed, U.S. National Library of Medicine · 2026
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    TAFINLAR (dabrafenib) capsules / tablets for oral suspension: Prescribing InformationNovartis Pharmaceuticals Corporation · DailyMed, U.S. National Library of Medicine · 2026
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    MEKINIST (trametinib) tablets / oral solution: Prescribing InformationNovartis Pharmaceuticals Corporation · DailyMed, U.S. National Library of Medicine · 2026
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    ENHERTU (fam-trastuzumab deruxtecan-nxki) for injection, for intravenous use: Prescribing InformationDaiichi Sankyo Inc · DailyMed, U.S. National Library of Medicine · 2026
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    LUMAKRAS (sotorasib) tablets, for oral use: Prescribing InformationAmgen Inc · DailyMed, U.S. National Library of Medicine · 2025
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    KRAZATI (adagrasib) tablets, for oral use: Prescribing InformationMirati Therapeutics, Inc · DailyMed, U.S. National Library of Medicine · 2026
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    TABRECTA (capmatinib) tablets, for oral use: Prescribing InformationNovartis Pharmaceuticals Corporation · DailyMed, U.S. National Library of Medicine · 2025
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    TEPMETKO (tepotinib) tablets, for oral use: Prescribing InformationEMD Serono, Inc · DailyMed, U.S. National Library of Medicine · 2025
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    RETEVMO (selpercatinib) capsules / tablets, for oral use: Prescribing InformationEli Lilly and Company · DailyMed, U.S. National Library of Medicine · 2026
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    GAVRETO (pralsetinib) capsules, for oral use: Prescribing InformationRigel Pharmaceuticals, Inc · DailyMed, U.S. National Library of Medicine · 2025
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    VITRAKVI (larotrectinib) capsules / oral solution: Prescribing InformationBayer HealthCare Pharmaceuticals Inc · DailyMed, U.S. National Library of Medicine · 2026
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    TECENTRIQ (atezolizumab) injection, for intravenous use: Prescribing InformationGenentech, Inc · DailyMed, U.S. National Library of Medicine · 2026
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    IMDELLTRA (tarlatamab-dlle) for injection, for intravenous use: Prescribing InformationAmgen, Inc · DailyMed, U.S. National Library of Medicine · 2026
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    Topotecan hydrochloride for injection, for intravenous use: Prescribing InformationFresenius Kabi USA, LLC · DailyMed, U.S. National Library of Medicine · 2026
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    HYCAMTIN (topotecan) capsules, for oral use: Prescribing InformationSandoz Inc · DailyMed, U.S. National Library of Medicine · 2023
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    Standard-dose versus high-dose conformal radiotherapy with concurrent and consolidation carboplatin plus paclitaxel with or without cetuximab for patients with stage IIIA or IIIB non-small-cell lung cancer (RTOG 0617): a randomised, two-by-two factorial phase 3 studyBradley JD, Paulus R, Komaki R, et al · Lancet Oncol · 2015;16:187-199
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    Neoadjuvant pembrolizumab plus chemotherapy followed by adjuvant pembrolizumab compared with neoadjuvant chemotherapy alone in patients with early-stage non-small-cell lung cancer (KEYNOTE-671): a randomised, double-blind, placebo-controlled, phase 3 trialSpicer JD, Garassino MC, Wakelee H, et al · Lancet · 2024;404:1240-1252
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    Randomized Phase III Study of Pemetrexed Plus Cisplatin Versus Vinorelbine Plus Cisplatin for Completely Resected Stage II to IIIA Nonsquamous Non-Small-Cell Lung CancerKenmotsu H, Yamamoto N, Yamanaka T, et al · J Clin Oncol · 2020;38:2187-2196
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    Radiation Therapy Regimens in Treating Patients With Limited-Stage Small Cell Lung Cancer Receiving Cisplatin and Etoposide (CALGB 30610/RTOG 0538) — NCT00632853Alliance for Clinical Trials in Oncology · ClinicalTrials.gov · 2008
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    SCLC on the 2nd Line With Relapsed After Response to Chemotherapy GFPC 01-2013 (carboplatin–etoposide vs topotecan) — NCT02738346University Hospital, Angers · ClinicalTrials.gov · 2016
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This page is based on reputable scientific sources and was last updated on 21 October 2026. The content of this website is for educational and informational purposes only and does not replace consultation, diagnosis or treatment by a specialist physician. Consult your treating physician about any treatment decision.

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