A Study of Atezolizumab Compared With Docetaxel in Non-Small Cell Lung Cancer (NSCLC) After Failure With Platinum-Containing Chemotherapy

Sponsor
Hoffmann-La Roche
Study ID
NCT02813785
Phase
PHASE3
Status
Completed

Conditions

  • Carcinoma, Non-Small-Cell Lung

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Atezolizumab (MPDL3280A), an engineered anti-PD-L1 antibody — DRUG
    Atezolizumab will be administered at a fixed dose of 1200 milligrams (mg) via intravenous (IV) infusion on Day 1 of each 21-day cycle.
  • Docetaxel — DRUG
    Docetaxel will be administered as 75 milligrams per square meter (mg/m\^2) via IV infusion on Day 1 of each 21-day cycle.

Study Details

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.

Key Dates

Start date
Jul 1, 2016
Status verified
Jan 2023
Primary completion
Aug 1, 2019
Completion
Dec 27, 2022

Study Design

Enrollment
565 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Atezolizumab
    Participants will receive atezolizumab until loss of clinical benefit and will thereafter enter survival follow-up until death, loss to follow-up, withdrawal, or study end.
  • Active Comparator: Docetaxel
    Participants will receive docetaxel until disease progression per standard RECIST v1.1 criteria or unacceptable toxicity and will thereafter enter survival follow-up until death, loss to follow-up, withdrawal, or study end.

Primary Outcome Measure

Overall Survival (OS) [ Time Frame: Baseline until death from any cause (up to approximately 3 years) ]

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