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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

NCT03191786 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 453

Last updated 2024-10-23

Study results available
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Summary

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).

Conditions

Interventions

DRUG

Atezolizumab (MPDL3280A), an engineered anti-PD-L1 antibody

Atezolizumab will be administered via IV infusion once every three weeks (QW3).

DRUG

Vinorelbine

Vinorelbine will be administered per relevant local guidelines and Summary of Product Characteristics (SmPC) management.

DRUG

Gemcitabine

Gemcitabine will be administered per relevant local guidelines and SmPC management.

Sponsors & Collaborators

Principal Investigators

  • Clinical Trials · Hoffmann-La Roche

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-09-11
Primary Completion
2022-04-30
Completion
2023-10-25
FDA Drug
Yes

Countries

  • Argentina
  • Belgium
  • Brazil
  • Bulgaria
  • Canada
  • China
  • Colombia
  • Czechia
  • Denmark
  • Germany
  • India
  • Ireland
  • Italy
  • Kazakhstan
  • Luxembourg
  • Mexico
  • Poland
  • Portugal
  • Romania
  • Slovakia
  • Spain
  • Switzerland
  • United Kingdom
  • Vietnam

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03191786 on ClinicalTrials.gov