A Study to Investigate the Safety and Efficacy of Atezolizumab in Previously-Treated Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer

Sponsor
Hoffmann-La Roche
Study ID
NCT03922997
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Atezolizumab — DRUG
    Atezolizumab will be administered at a fixed dose of 1200 mg intravenously on the first day of each 21-day cycle.

Study Details

This is a phase III, single-arm, multicenter study of the long-term safety and efficacy of atezolizumab treatment in patients with Stage IIIb or Stage IV non-small cell lung cancer (NSCLC) who have progressed following standard systemic chemotherapy (including if given in combination with anti-PD-1 therapy or after anti-PD-1 as monotherapy).

Key Dates

Start date
Jul 3, 2019
Status verified
Sep 2022
Primary completion
Aug 11, 2022
Completion
Aug 11, 2022

Study Design

Enrollment
101 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Atezolizumab
    Participants will receive atezolizumab intravenously on the first day of each cycle. Atezolizumab treatment will continue until investigator-assessed loss of clinical benefit, unacceptable toxicity, investigator or patient decision to withdraw from therapy, or death (whichever occurs first).

Primary Outcome Measure

Serious Adverse Event Incidence Rates [ Time Frame: Baseline up to approximately 3 years ]

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