A Study of Tiragolumab Plus Atezolizumab Compared With Placebo Plus Atezolizumab in Participants With Completely Resected Non-small Cell Lung Cancer Who Have Received Adjuvant Platinum-based Chemotherapy
Sponsor: Hoffmann-La Roche
Sponsor score: 40
Inactive
ClinicalTrials ID:NCT06267001
This study assesses the efficacy and safety of tiragolumab plus atezolizumab versus placebo plus atezolizumab in NSCLC patients post-resection and chemotherapy. Eligible participants have Stage IIB-IIIB NSCLC, ECOG status 0-1, PD-L1 expression ≥1%, and adequate recovery from surgery and chemotherapy. Interventions include IV administration of atezolizumab, tiragolumab, or placebo.
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Program Overview
The purpose of this study is to evaluate the efficacy and safety of tiragolumab plus atezolizumab compared with placebo plus atezolizumab administered to participants with non-small cell lung cancer (NSCLC) following resection and adjuvant chemotherapy.
Eligibility Criteria
Inclusion Criteria
- Eastern Cooperative Oncology Group performance status of 0 or 1
- Histological or cytological diagnosis of Stage IIB, IIIA, and select IIIB NSCLC of either non-squamous or squamous histology
- Participants must have had complete resection of NSCLC
- Participants must have received between one to four cycles of adjuvant histology-based platinum doublet chemotherapy
- Participants must have recovered adequately from surgery and from adjuvant chemotherapy
- Tumor cell PD-L1 expression at >/= 1%
- Adequate hematologic and end-organ function.
Exclusion Criteria
- Any history of prior NSCLC within the last 5 years
- Any evidence of residual disease or disease recurrence following surgical resection of NSCLC, or during or following adjuvant chemotherapy
- NSCLC known to have mutation in the EGFR gene or an ALK fusion oncogene
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