Atezolizumab (MPDL3280A), an engineered anti-PD-L1 antibody
DrugAtezolizumab will be administered at a fixed dose of 1200 milligrams (mg) via intravenous (IV) infusion on Day 1 of each 21-day cycle.
Other names: MDPL3280A, RO5541267
NCT Number: NCT02813785
This Phase III, multicenter, open-label, randomized, controlled study is designed to evaluate the efficacy and safety of the anti-programmed death-ligand 1 (PD-L1) antibody atezolizumab compared with docetaxel in participants with locally advanced or metastatic NSCLC who have progressed during or following a platinum-containing regimen. Treatment may continue until disease progression, loss of clinical benefit, or unacceptable toxicity.
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Notify Me18 year and older
All sexes
Interventional
Phase 3
Beijing Cancer Hospital, Beijing, China
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Atezolizumab will be administered at a fixed dose of 1200 milligrams (mg) via intravenous (IV) infusion on Day 1 of each 21-day cycle.
Other names: MDPL3280A, RO5541267
Docetaxel will be administered as 75 milligrams per square meter (mg/m^2) via IV infusion on Day 1 of each 21-day cycle.
Other names: Taxotere
Time frame: Baseline until death from any cause (up to approximately 3 years)
Time frame: Baseline until disease progression or death from any cause (up to approximately 3 years)
Time frame: Baseline until disease progression or death from any cause (up to approximately 3 years)
Time frame: From first objective response until disease progression or death from any cause (up to approximately 3 years)
Time frame: From start of treatment until 90 days after treatment discontinuation or initiation of other anti-cancer therapy (up to approximately 3 years)
Time frame: Predose (0 hours) on Day 1 of Cycles 1, 2, 3, 4, 8, 16, and every eight cycles thereafter (cycle length of 21 days) until/at treatment discontinuation (up to approximately 3 years) and 120 days after last dose (up to approximately 3 years overall)
Time frame: Predose (0 hours) on Day 1 of Cycles 1, 2, 3, 4, 8, 16, and every eight cycles thereafter (cycle length of 21 days) until/at treatment discontinuation (up to approximately 3 years) and 120 days after last dose (up to approximately 3 years overall)
Time frame: From start of treatment until treatment discontinuation (up to approximately 3 years)
Time frame: From start of treatment until treatment discontinuation (up to approximately 3 years)
Time frame: Day 1 of every cycle (cycle length of 21 days) until/at treatment discontinuation (up to approximately 3 years)
Time frame: Day 1 of every cycle (cycle length of 21 days) until/at treatment discontinuation (up to approximately 3 years)
Hoffmann-La Roche
Industry
A Phase III, Open-Label, Multicenter, Randomized Study to Investigate the Efficacy and Safety of Atezolizumab (Anti-PD-L1 Antibody) Compared With Docetaxel in Patients With Non-Small Cell Lung Cancer After Failure With Platinum-Containing Chemotherapy
Acronym: IMpower210
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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