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
See if I qualify
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 18years - 100years
Treatment Placebo, Atezolizumab, Carboplatin, Etoposide, Tiragolumab
Clinical Study IdentifierNCT04256421
SponsorHoffmann-La Roche
Last Modified on19 February 2024

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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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

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