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

COMPLETEDPHASE3

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

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

NCT02763579•Hoffmann-La Roche

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Histologically or cytologically confirmed ES-SCLC (per the Veterans Administration Lung Study Group \[VALG\] staging system)
•No prior systemic treatment for ES-SCLC
•Eastern Cooperative Oncology Group performance status of 0 or 1
•Measurable disease, as defined by 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

Exclusion Criteria

•Active or untreated central nervous system (CNS) metastases as determined by computed tomography (CT) or magnetic resonance imaging (MRI) evaluation
•Malignancies other than SCLC within 5 years prior to randomization, with the exception of those with a negligible risk of metastasis or death treated with expected curative outcome
•Pregnant or lactating women
•History of autoimmune disease
•History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest CT scan. History of radiation pneumonitis in the radiation field (fibrosis) is permitted.
•Positive test result for human immunodeficiency virus (HIV)
•Active hepatitis B or hepatitis C
•Severe infections at the time of randomization
•Significant cardiovascular disease
•Prior treatment with cluster of differentiation (CD) 137 agonists or immune checkpoint blockade therapies, anti-programmed death-1 (PD-1), and anti-PD-L1 therapeutic antibody
+1 more criteria

Locations (114)

Florida Cancer Specialists - Fort Myers (Broadway)

Fort Myers, Florida, United States

Florida Hospital

Orlando, Florida, United States

Florida Cancer Specialists.

St. Petersburg, Florida, United States

Northwest Georgia Oncology Centers PC - Marietta

Marietta, Georgia, United States

Rush University Medical Center

Chicago, Illinois, United States

Illinois Cancer Care

Peoria, Illinois, United States

Cancer Treatment Centers of America - Midwestern Regional Medical Center

Zion, Illinois, United States

Louisville Oncology

Louisville, Kentucky, United States

New England Cancer Specialists

Scarborough, Maine, United States

Weinberg CA Inst Franklin Sq

Baltimore, Maryland, United States

Key Dates

Start Date

June 7, 2016

Primary Completion Date

April 24, 2018

Completion Date

July 7, 2022

Last Updated

July 28, 2023

Enrollment

503

ACTUAL participants

Conditions

Small Cell Lung Carcinoma

Interventions

Atezolizumab (MPDL3280A), an engineered anti-PD-L1 antibody

DRUG

Carboplatin

DRUG

Etoposide

DRUG

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: July 28, 2023Data 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.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

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