Adjuvant atezolizumab after adjuvant chemotherapy in resected stage IB–IIIA non-small-cell lung cancer (IMpower010): a randomised, multicentre, open-label, phase 3 trial
- Study type
- Clinical trial
- Study name
- IMpower010
- Phase
- Phase 3
- Design
- Randomised, multicentre, open-label trial with 1:1 allocation using permuted blocks (block size 4), conducted at 227 centres in 22 countries and regions
- Sample size
- 1280 patients were enrolled; 1269 received adjuvant chemotherapy and 1005 were eligible for randomisation (507 atezolizumab and 498 best supportive care)
- Source
- The Lancet · 2021
- Trial registration
- NCT02486718
In plain words
In this study, patients whose lung cancer had been completely removed by surgery and who had also received chemotherapy were split into two groups: one group received the immunotherapy drug atezolizumab for up to one year, and the other had only regular care and check-ups. Atezolizumab lowered the risk of the cancer coming back or of death, and this effect was clearer in patients whose cancer was stage II to IIIA and whose tumour cells carried the PD-L1 protein at a level of 1% or more. About 11% of patients had serious (grade 3 and 4) side effects related to the drug. The decision to use this treatment should be made with your doctor.
Key results
Treatment arms and regimens
Enrolment phase (all patients, before randomisation): cisplatin-based adjuvant chemotherapy for up to 4 cycles of 21 days — cisplatin 75 mg/m² IV day 1 plus one of: vinorelbine 30 mg/m² IV days 1 and 8, docetaxel 75 mg/m² IV day 1, gemcitabine 1250 mg/m² IV days 1 and 8, or pemetrexed 500 mg/m² IV day 1 (non-squamous only). Started 28 to 84 days after surgery; patients who completed at least 1 cycle without recurrence were randomised.
Randomised phase: atezolizumab 1200 mg IV every 3 weeks (day 1 of a 21-day cycle) for 16 cycles (1 year) or until recurrence or unacceptable toxicity, with periodic imaging (495 patients treated).
Enrolment phase (all patients, before randomisation): cisplatin-based adjuvant chemotherapy for up to 4 cycles of 21 days — cisplatin 75 mg/m² IV day 1 plus one of: vinorelbine 30 mg/m² IV days 1 and 8, docetaxel 75 mg/m² IV day 1, gemcitabine 1250 mg/m² IV days 1 and 8, or pemetrexed 500 mg/m² IV day 1 (non-squamous only). Started 28 to 84 days after surgery; patients who completed at least 1 cycle without recurrence were randomised.
Randomised phase: best supportive care — observation only, with regular imaging (chest radiography and CT) to detect recurrence (495 patients).
Source of the regimen details: ClinicalTrials.gov NCT02486718 (chemotherapy and atezolizumab doses), full text of the Japanese subgroup report of the same trial in Cancer Sci 2026 (PMC12951087; timing of chemotherapy start and randomisation criterion) and the FDA label for Tecentriq (DailyMed, section 14.1)
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.
Study population
Patients aged ≥18 years with completely resected stage IB (tumour ≥4 cm) to IIIA NSCLC (UICC/AJCC 7th edition), ECOG 0 or 1 and suitable for cisplatin-based chemotherapy; patients with EGFR mutations or ALK rearrangements were also enrolled. Exclusion criteria (FDA label): history of autoimmune disease, idiopathic pulmonary fibrosis, organising pneumonia or drug-induced/active pneumonitis, a live vaccine within the past 28 days and systemic immunosuppressive drugs within the past 2 weeks. Patients were randomised after 1 to 4 cycles of adjuvant chemotherapy.
Endpoints
Primary endpoint: investigator-assessed disease-free survival (DFS), tested hierarchically: first in the stage II–IIIA subgroup with PD-L1 expression on 1% or more of tumour cells (SP263), then in all stage II–IIIA patients and finally in the intention-to-treat population (ITT, stage IB–IIIA). Safety was assessed in all randomised patients who received atezolizumab or best supportive care.
Safety and side effects
Atezolizumab-related grade 3 and 4 adverse events occurred in 53 (11%) of 495 patients and grade 5 events in 4 patients (1%). According to the FDA label: serious adverse events 18% (pneumonia 1.8%, pneumonitis 1.6%, pyrexia 1.2%); atezolizumab discontinuation due to adverse events 18% (pneumonitis 2.2%, hypothyroidism 1.6%, increased AST 1.4%); treatment interruption 29%. Immune-related adverse events: hypothyroidism 17%, hyperthyroidism 6%, pneumonitis 3.8%, adrenal insufficiency 1.2%. The median number of cycles received was 16. No new safety signals were observed.
Clinical significance and place in guidelines
According to the abstract, atezolizumab after adjuvant chemotherapy is a promising option for patients with resected early-stage NSCLC, with the greatest benefit seen in stage II–IIIA patients with PD-L1 expression on 1% or more of tumour cells. The abstract gives no information on overall survival, regulatory approvals or guideline recommendations; the current status of guidelines and approvals should be checked separately.
Limitations
The study was open-label and the primary endpoint was investigator-assessed. Median follow-up in the stage II–IIIA population was 32.2 months. According to the abstract, hypothesis testing was hierarchical, and the effect in the ITT population (p=0.040) and in the whole stage II–IIIA population (p=0.020) was weaker than in the PD-L1-positive subgroup. Other limitations should be checked in the full text.
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.