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Completed Phase 3 Interventional Results available

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

ClinicalTrials.gov ID: NCT04256421

Public ClinicalTrials.gov record NCT04256421. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 2, 2026, 5:27 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official 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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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 stratified by Eastern Cooperative Oncology Group (ECOG) Performance Status (0 vs. 1), LDH (\</= upper limit of normal \[ULN\] vs. \> ULN), and presence or history of brain metastasis (yes vs. no) and randomly assigned in a 1:1 ratio to receive one of the following treatment regimens during induction phase: * Arm A: Tiragolumab plus atezolizumab plus CE * Arm B: Placebo plus atezolizumab plus CE Following the induction phase, participants will continue maintenance therapy with either atezolizumab plus tiragolumab (Arm A) or atezolizumab plus placebo (Arm B).

Study identification

NCT ID
NCT04256421
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Hoffmann-La Roche
Industry
Enrollment
490 participants

Conditions and interventions

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Feb 3, 2020
Primary completion
Sep 5, 2022
Completion
Jul 30, 2025
Last update posted
Apr 2, 2026

2020 – 2025

United States locations

U.S. sites
18
U.S. states
14
U.S. cities
18
Facility City State ZIP Site status
Rocky Mountain Cancer Centers - Lone Tree Lone Tree Colorado 80124
MedStar Georgetown University Hospital (Lombardi Comprehensive Cancer Center) Washington D.C. District of Columbia 20007
Florida Cancer Specialists Fort Myers Florida 33901
SCRI Florida Cancer Specialists North Sarasota Florida 34232
Northwest Georgia Oncology Centers PC - Marietta Marietta Georgia 30060
Illinois Cancer Care Peoria Illinois 61615
New England Cancer Specialists Scarborough Maine 04074
Weinberg Cancer Institution at Franklin Square Baltimore Maryland 21237
Minnesota Oncology Hematology Minneapolis Minnesota 55404
Comprehensive Cancer Centers of Nevada Henderson Nevada 89052
Broome Oncology - Binghamton Binghamton New York 13905
Memorial Sloan Kettering Cancer Center New York New York 10065
Sarah Cannon Research Institute / Tennessee Oncology Chattanooga Tennessee 37404
Sarah Cannon Research Inst. Nashville Tennessee 37203
Texas Oncology Cancer Center Austin Texas 78731
Virginia Cancer Specialists Fairfax Virginia 22031
Blue Ridge Cancer Care Roanoke Virginia 24014
University of Wisconsin School of Medicine and Public Health Madison Wisconsin 53792

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 103 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT04256421, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Apr 2, 2026 · Synced Sep 2, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT04256421 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →