Study of Atezolizumab Plus Carboplatin and Etoposide With or Without Tiragolumab in Participants With Untreated Extensive-Stage Small Cell Lung Cancer

Sponsor
Hoffmann-La Roche
Study ID
NCT04665856
Phase
PHASE3
Status
Active Not Recruiting

Conditions

  • Small Cell Lung Carcinoma

Eligibility Criteria

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

Interventions

  • Tiragolumab — DRUG
    Tiragolumab at a fixed dose of 600 milligrams (mg), administered by intravenous (IV) infusion, every 3 weeks (Q3W) on Day 1 of each 21-day cycle.
  • Atezolizumab — DRUG
    Atezolizumab at a fixed dose of 1200 mg, administered by IV infusion, Q3W on Day 1 of each 21-day cycle.
  • Carboplatin — DRUG
    Carboplatin administered IV to achieve an initial target area under the concentration time curve (AUC) of 5 mg/mL/min, Q3W on Day 1 of each 21-day cycle for 4 cycles.
  • Etoposide — DRUG
    Etoposide 100 mg/m\^2, administered by IV infusion, Q3W on Day 1, 2 and 3 of each 21-day cycle for 4 cycles.
  • Tiragolumab Matching Placebo — DRUG
    Matching placebo, administered by IV infusion, Q3W on Day 1 of each 21-day cycle.

Study Details

The purpose of this multicenter study in China is to evaluate the safety and efficacy of tiragolumab plus atezolizumab and carboplatin and etoposide (CE) compared with placebo plus atezolizumab and CE in participants with untreated extensive-stage small cell lung cancer.

Key Dates

Start date
Dec 21, 2020
Status verified
Jan 2026
Primary completion
Aug 31, 2023
Completion
Jun 30, 2026

Study Design

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

Arms

  • Experimental: Tiragolumab + Atezolizumab + Carboplatin and Etoposide
    Induction treatment with tiragolumab plus atezolizumab and CE will be administered on a 21-day cycle for 4 cycles. Following the induction phase, participants will continue maintenance therapy with tiragolumab plus atezolizumab for 21-day cycles.
  • Placebo Comparator: Placebo + Atezolizumab + Carboplatin and Etoposide
    Induction treatment with placebo plus atezolizumab and CE will be administered on a 21-day cycle for 4 cycles. Following the induction phase, participants will continue maintenance therapy with placebo plus atezolizumab for 21-day cycles

Primary Outcome Measure

Investigator-Assessed Progression-Free Survival (PFS) in the Primary Analysis Set (PAS) [ Time Frame: Up to 32.3 months ]

Related coverage on Hipa.ai

Related Studies