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

ACTIVE_NOT_RECRUITINGPHASE3

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

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

NCT04665856•Hoffmann-La Roche

View on ClinicalTrials.gov

Summary

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
•Histologically or cytologically confirmed Extensive-Stage Small Cell Lung Cancer (ES-SCLC) per the modified Veterans Administration Lung Study Group (VALG) staging system
•No prior systemic treatment for ES-SCLC
•For participants who have received prior chemoradiotherapy for limited-stage SCLC must have had treatment with curative intent and a treatment-free interval of at least 6 months between the last dose/cycle of chemotherapy, thoracic radiotherapy, or chemoradiotherapy and the diagnosis of ES-SCLC
•Measurable diseases as defined by RECIST v1.1
•Submission of a pre-treatment tumor tissue sample
•Adequate hematologic and end-organ function
•Participants not receiving therapeutic anticoagulation with International Normalized Ratio (INR) and Activated Clotting Time (aPTT) \</= 1.5 x ULN
•Participants receiving therapeutic anticoagulation: stable anticoagulant regimen
•Negative Human Immunodeficiency Virus (HIV) test at screening
+6 more criteria

Exclusion Criteria

•Symptomatic or actively progressing central nervous system (CNS) metastases
•Spinal cord compression
•Leptomeningeal disease
•Uncontrolled pleural effusion, pericardial effusion, or ascites
•Uncontrolled or symptomatic hypercalcemia
•Known clinically significant liver disease, including active viral, alcoholic, or other hepatitis, cirrhosis, and inherited liver disease, or current alcohol abuse
•Malignancies other than SCLC within 5 years prior to randomization
•Active or history of autoimmune disease or immune deficiencies
•History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest Computer Tomography (CT) scan
•Known active tuberculosis, Current treatment with anti-viral therapy for HBV or HCV
+14 more criteria

Locations (16)

Beijing Cancer Hospital

Beijing, China

Beijing Chest Hospital

Beijing, China

the First Affiliated Hospital of Bengbu Medical College

Bengbu, China

the First Hospital of Jilin University

Changchun, China

Fujian Provincial Cancer Hospital

Fuzhou, China

Cancer Center of Guangzhou Medical University

Guangzhou, China

Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University

Hangzhou, China

Zhejiang Cancer Hospital

Hangzhou, China

Harbin Medical University Cancer Hospital

Harbin, China

The 1st Affiliated Hospital of Nanchang Unversity

Nanchang, China

Key Dates

Start Date

December 21, 2020

Primary Completion Date

August 31, 2023

Completion Date

June 30, 2026

Last Updated

February 13, 2026

Enrollment

123

ACTUAL participants

Conditions

Small Cell Lung Carcinoma

Interventions

Tiragolumab

DRUG

Atezolizumab

DRUG

Carboplatin

DRUG

Etoposide

DRUG

Tiragolumab Matching Placebo

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 13, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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