At a glance
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A Phase III, Open-Label, Randomized Study to Investigate the Efficacy and Safety of Atezolizumab (Anti-PD-L1 Antibody) Compared With Best Supportive Care Following Adjuvant Cisplatin-Based Chemotherapy in Patients With Completely Resected Stage IB-IIIA Non-Small Cell Lung Cancer
In Brief
A Phase 3 clinical trial evaluating Atezolizumab, Cisplatin, and 4 other interventions for Non-Small Cell Lung Cancer. Active but no longer recruiting, targeting 1,280 participants across 154 sites in 21 countries.
Detailed Summary
This is a Phase III, global, multicenter, open-label, randomized study to compare the efficacy and safety of 16 cycles (1 cycle duration=21 days) of atezolizumab (MPDL3280A) treatment compared with best supportive care (BSC) in participants with Stage IB-Stage IIIA non-small cell lung cancer (NSCLC) following resection and adjuvant chemotherapy, as measured by disease-free survival (DFS) as assessed by the investigator and overall survival (OS). Participants, after completing up to 4 cycles of adjuvant cisplatin-based chemotherapy, will be randomized in a 1:1 ratio to receive atezolizumab for 16 cycles or BSC.
Study Details
Timeline
Interventions
Participants will receive atezolizumab (1200 mg IV) Q3W for 16 cycles (cycle length=21 days).
Participants will receive cisplatin 75 milligrams per square meter (mg/m\^2) IV on Day 1 of up to four 21-day cycles.
Participants will receive vinorelbine 30 mg/m\^2 IV on Days 1 and 8 of each of the four 21-day cycles.
Participants will receive docetaxel 75 mg/m\^2 IV on Day 1 of each of the four 21-day cycles.
Participants will receive gemcitabine 1250 mg/m\^2 IV on Days 1 and 8 of each of the four 21-day cycles.
Participants will receive pemetrexed 500 mg/m\^2 IV on Day 1 of each of the four 21-day cycles. Pemetrexed will be administered only in participants with non-squamous cell NSCLC.