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

STATUS

Recruiting
participants needed

400
sponsor

Hoffmann-La Roche

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Updated on 19 February 2024

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cancer

measurable disease

atezolizumab

carboplatin

solid tumour

lung cancer

etoposide

maintenance therapy

solid neoplasm

extensive stage small cell lung cancer

small cell lung cancer

tiragolumab

extensive stage sclc

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).

Details

Condition	Small Cell Lung Cancer, Small Cell Lung Cancer
Age	18-100 years
Treatment	Placebo, Atezolizumab, Carboplatin, Etoposide, Tiragolumab
Clinical Study Identifier	NCT04256421
Sponsor	Hoffmann-La Roche
Last Modified on	19 February 2024

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Eligibility		Yes	No	Not Sure
Inclusion Criteria
	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
Exclusion Criteria
	Symptomatic or actively progressing central nervous system (CNS) metastases
	Malignancies other than small cell lung cancer (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
	Active or history of autoimmune disease or immune deficiency
	History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (CT) scan
	Positive test result for human immunodeficiency virus (HIV)
	Active hepatitis B or hepatitis C
	Severe infection at the time of randomization
	Treatment with any other investigational agent within 28 days prior to initiation of study treatment
	Prior treatment with CD137 agonists or immune checkpoint blockade therapies, anti-CTLA-4, anti-TIGIT, anti-PD-1, and anti-PD-L1 therapeutic antibodies
	Treatment with systemic immunostimulatory agents within 4 weeks or 5 drug elimination half-lives prior to randomization

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Study Definition

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