OncRef

Clinical Trial: NCT02763579

A Study of Carboplatin Plus Etoposide With or Without Atezolizumab in Participants With Untreated Extensive-Stage (ES) Small Cell Lung Cancer (SCLC)

Status:

COMPLETED

Phase:

Phase 3

Lead Sponsor:Hoffmann-La Roche
Information Provided By:Hoffmann-La Roche
Last Update Posted:2023-07-28

Study Overview

Brief Summary

This randomized, Phase I/III, multicenter, double-blinded, placebo-controlled study was designed to evaluate the safety and efficacy of atezolizumab (anti-programmed death-ligand 1 [PD-L1] antibody) in combination with carboplatin plus (+) etoposide compared with treatment with placebo + carboplatin + etoposide in chemotherapy-naive participants with ES-SCLC. Participants will be randomized in a 1:1 ratio to receive either atezolizumab + carboplatin + etoposide or placebo + carboplatin + etoposide on 21-day cycles for four cycles in the induction phase followed by maintenance with atezolizumab or placebo until progressive disease (PD) as assessed by the investigator using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1). Treatment can be continued until persistent radiographic PD or symptomatic deterioration.

Official Title

A Phase I/III, Randomized, Double-Blind, Placebo-Controlled Study of Carboplatin Plus Etoposide With or Without Atezolizumab (Anti-PD-L1 Antibody) in Patients With Untreated Extensive-Stage Small Cell Lung Cancer

Conditions

Small Cell Lung Carcinoma

Intervention / Treatment

  • Drug: Atezolizumab (MPDL3280A), an engineered anti-PD-L1 antibody
  • Drug: Carboplatin
  • Drug: Etoposide
  • Drug: Placebo

Other Study ID Numbers

  • GO30081
  • 2015-004861-97
  • 2015

Start Date (Actual)

2016-06-07

Primary Completion Date (Actual)

2018-04-24

Study Completion Date (Actual)

2022-07-07

Enrollment (Actual)

503

Study Type

Interventional

Phase

Phase 3