A Study of Atezolizumab Compared With a Single-Agent Chemotherapy in Treatment Naïve Participants With Locally Advanced or Recurrent or Metastatic Non-Small Cell Lung Cancer Who Are Deemed Unsuitable For Platinum-Doublet Chemotherapy

Sponsor
Hoffmann-La Roche
Study ID
NCT03191786
Phase
PHASE3
Status
Completed

Conditions

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 via IV infusion once every three weeks (QW3).
  • Vinorelbine — DRUG
    Vinorelbine will be administered per relevant local guidelines and Summary of Product Characteristics (SmPC) management.
  • Gemcitabine — DRUG
    Gemcitabine will be administered per relevant local guidelines and SmPC management.

Study Details

This Phase III, global, multicenter, open-label, randomized, controlled study will evaluate the efficacy and safety of atezolizumab (an anti-programmed death-ligand 1 \[anti-PD-L1\] antibody) compared with a single agent chemotherapy regimen by investigator choice (vinorelbine or gemcitabine) in treatment-naïve participants with locally advanced or metastatic non-small cell lung cancer (NSCLC) who are deemed unsuitable for any platinum-doublet chemotherapy due to poor performance status (Eastern Cooperative Oncology Group \[ECOG\] performance status of 2-3).

Key Dates

Start date
Sep 11, 2017
Status verified
Sep 2024
Primary completion
Apr 30, 2022
Completion
Oct 25, 2023

Study Design

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

Arms

  • Experimental: Atezolizumab
    Participants will receive atezolizumab 1200 milligrams (mg) intravenous (IV) infusion on Day 1 of each 21-day cycle until loss of clinical benefit, unacceptable toxicity, participant or physician decision to discontinue, or death.
  • Active Comparator: Single Agent Chemotherapy (Vinorelbine or Gemcitabine)
    Participants will receive single agent chemotherapy; either vinorelbine oral or IV, or gemcitabine IV, according to the label based on investigator's choice.

Primary Outcome Measure

Overall Survival (OS) [ Time Frame: From randomization up to death from any cause (up to approximately 55 months) ]

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