A small percentage of non-small-cell lung cancers (especially in younger people and non-smokers) have an ALK gene change. In this study, patients who took alectinib tablets for 2 years after surgery instead of chemotherapy had a much lower chance of the cancer coming back (after 2 years about 94% versus 63% were free of recurrence), and recurrence in the brain was also less common. It is not yet known whether this benefit also leads to longer life.
Resected ALK-positive NSCLC (tumour ≥4 cm or node-positive)
| Drug | Dose | Route | Schedule |
|---|---|---|---|
| Alectinib | 600 mg | Oral, with food | Twice daily, continuous |
Source: FDA label for alectinib; trial (vs platinum chemotherapy). 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).
On the page “Lung cancer” · Resectable NSCLC: treatment before or after surgery
ALK-positive lung cancer after surgery
| Drug | Dose | Route | Schedule |
|---|---|---|---|
| Alectinib | 600 mg twice a day | Oral, with food | Daily |
As in ALINA; dose source:.
On the page “Adjuvant alectinib after surgery for ALK-positive lung cancer (ALINA)”
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.
Alectinib 600 mg orally twice daily (with food, according to the label) for 24 months or until disease recurrence, unacceptable toxicity or withdrawal. Dose-reduction levels according to the label: 450 mg and then 300 mg twice daily (discontinue if 300 mg is not tolerated). Monitor liver enzymes and bilirubin every 2 weeks for the first 3 months and then monthly; CPK every 2 weeks in the first month.
IV platinum-based chemotherapy, 4 cycles of 21 days, one of these regimens:
If cisplatin was not tolerated, carboplatin AUC 5 or 6 mg/mL·min was given instead.
Source of the regimen details: FDA label for Alecensa (DailyMed, sections 14.1 and 2.4, August 2026 version) and ClinicalTrials.gov NCT03456076; treatment duration from the abstract of the paper
Doses are given for the information of specialists, as in this study’s protocol, and are not a prescription. Every drug must be prescribed by the treating physician for the individual patient.
Adults with completely resected ALK-positive NSCLC, stage IB (tumour ≥4 cm), II or IIIA according to the AJCC/UICC 7th edition; ALK rearrangement by a local FDA-approved test or the central VENTANA ALK (D5F3) test. Randomisation was stratified by race (Asian or non-Asian) and stage (IB, II, IIIA).
Primary endpoint: disease-free survival (DFS), tested hierarchically first in stage II–IIIA and then in the overall ITT population. Other endpoints: CNS disease-free survival, overall survival and safety.
According to the FDA label (median exposure 23.9 months for alectinib and 2.1 months for chemotherapy): serious adverse events in 13% of patients in the alectinib group (pneumonia 3.9%, appendicitis 3.1%, acute myocardial infarction 1.6%). Permanent discontinuation of alectinib due to adverse events 5% (mainly pneumonitis and hepatotoxicity), dose interruption 27% and dose reduction 26%. Hepatotoxicity 61% (grade ≥3: 4.7%; mostly in the first 3 months), increased CPK 77% (grade ≥3: 6%), constipation 42%, myalgia 34%, rash 23%, oedema 16%, haemolytic anaemia 3.1%. No unexpected safety findings were seen.
ALINA was the first phase 3 trial to show the superiority of an ALK inhibitor in the adjuvant setting and led to FDA approval (April 2024) of adjuvant alectinib for resected ALK-positive NSCLC. This finding reinforced the need for ALK testing (alongside EGFR) in all resected patients and before starting neoadjuvant immunotherapy.
Overall survival is immature; the design was open-label; the comparator was chemotherapy rather than an immunotherapy-based approach; few patients had stage IB disease; staging was based on the 7th edition.
This summary was prepared by the editorial team from the published paper; the original paper is the final reference. Read the original abstract on PubMed.
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