Recruiting

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

# NCT04256421 Trial phase: 3 Study type: immunotherapy, chemotherapy

Study Start Date

February, 2020

Scientific Title

A Phase III, Randomized, Double-Blind, Placebo-Controlled Study of Atezolizumab Plus Carboplatin and Etoposide With or Without Tiragolumab (Anti-Tigit Antibody) in Patients With Untreated Extensive-Stage Small Cell Lung Cancer

Summary

This study will evaluate the efficacy of tiragolumab plus atezolizumab and carboplatin and etoposide (CE) compared with placebo plus atezolizumab and CE in participants with chemotherapy-naive extensive-stage small cell lung cancer (ES-SCLC). Eligible participants will be randomized in a 1:1 ratio to receive one of the following treatment regimens during induction phase:- - Arm A: Tiragolumab plus atezolizumab and CE - Arm B: Placebo plus atezolizumab and CE Following the induction phase, participants will continue maintenance therapy with either atezolizumab plus tiragolumab (Arm A) or atezolizumab plus placebo (Arm B).

- Histologically or cytologically confirmed extensive-stage small cell lung cancer (ES-SCLC) - No prior systemic treatment for ES-SCLC - Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 - Measurable disease, as defined by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) - Adequate hematologic and end-organ function - Treatment-free for at least 6 months since last chemo/radiotherapy, among those treated (with curative intent) with prior chemo/radiotherapy for limited-stage SCLC

Study Design

Primary purpose: Treatment , Allocation: Randomized , Intervention model: Parallel Assignment , Masking: Triple , Subject masked: Yes , Caregiver masked: Yes , Investigator masked: Yes

Conditions

Small Cell Lung Cancer

Locations

Roche

Roche

Official trial

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