A Study of Atezolizumab in High PD-L1 Expression, Chemotherapy-Naïve Patients With Stage IV Non-Squamous or Squamous Non-Small Cell Lung Cancer

Sponsor
Hoffmann-La Roche
Study ID
NCT05047250
Phase
PHASE3
Status
Active Not Recruiting

Conditions

Eligibility Criteria

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

Interventions

  • Atezolizumab — DRUG
    Atezolizumab will be administered by IV infusion at a fixed dose of 1200 mg on Day 1 of each 21-day cycle until unacceptable toxicity or loss of clinical benefit as determined by investigators.

Study Details

This is a Phase III, single arm, multicenter study designed to evaluate the efficacy and safety of atezolizumab in high PD-L1 expression, chemotherapy-naïve, without a sensitizing EGFR mutation or ALK translocation patients with stage IV non-squamous or squamous NSCLC.

Key Dates

Start date
Jun 14, 2022
Status verified
Apr 2026
Primary completion
Dec 30, 2025
Completion
Aug 30, 2027

Study Design

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

Arms

  • Experimental: Atezolizumab
    Participants will receive IV infusion of atezolizumab on Day 1 of each 21-day cycle until unacceptable toxicity or loss of clinical benefit as determined by investigators.

Primary Outcome Measure

Overall survival (OS) [ Time Frame: Atezolizumab initiation to death from any cause (up to approximately 28 months) ]

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