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
- Conditions
- Non-small Cell Lung Cancer (NSCLC)
- Interventions
- Registration Number
- NCT06267001
- Lead Sponsor
- Hoffmann-La Roche
- Brief Summary
The purpose of this study was 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.
- Detailed Description
With Protocol Amendment 2, enrollment will be stopped. The primary objective of the study has been changed to a safety objective and no other analysis will be conducted
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 56
- Eastern Cooperative Oncology Group (ECOG) 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.
- 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 epidermal growth factor receptor (EGFR) gene or an anaplastic lymphoma kinase (ALK) fusion oncogene
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Atezolizumab + Tiragolumab Atezolizumab Participants will receive atezolizumab and tiragolumab intravenously (IV). Atezolizumab + Tiragolumab Tiragolumab Participants will receive atezolizumab and tiragolumab intravenously (IV). Atezolizumab + Placebo Atezolizumab Participants will receive atezolizumab and placebo IV. Atezolizumab + Placebo Placebo Participants will receive atezolizumab and placebo IV.
- Primary Outcome Measures
Name Time Method Percentage of Participants With Adverse Events (AEs) Up to approximately 2 years
- Secondary Outcome Measures
Name Time Method DFS Rate Year 3, Year 5, Year 7 Overall Survival (OS) Up to approximately 15 years Percentage of Participants With Anti-Drug Antibodies (ADAs) to Tiragolumab Up to approximately 1 year Percentage of Participants Who Maintained or Meaningfully Improved from Baseline in Patient-reported Role, Emotional, and Physical Functioning and Global Health Status (GHS)/Quality of Life (QoL) Up to approximately 1 year Serum Concentration of Atezolizumab Up to approximately 1 year Percentage of Participants With Adverse Events (AEs) Up to approximately 15 years Percentage of Participants With ADAs to Atezolizumab Up to approximately 1 year Serum Concentration of Tiragolumab Up to approximately 1 year
Related Research Topics
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Trial Locations
- Locations (163)
Arizona Oncology Associates, PC - NAHOA
🇺🇸Prescott, Arizona, United States
The Oncology Institute of Hope and Innovation; Cerritos
🇺🇸Cerritos, California, United States
Glendale Adventist Medical Ctr
🇺🇸Glendale, California, United States
University of California, San Francisco; Medical Center
🇺🇸San Francisco, California, United States
Eastern CT Hematology and Oncology Associates
🇺🇸Norwich, Connecticut, United States
The Oncology Institute of Hope and Innovation - Florida
🇺🇸Fort Lauderdale, Florida, United States
Florida Cancer Specialists - SOUTH - SCRI - PPDS
🇺🇸Fort Myers, Florida, United States
Woodlands Medical Specialists, P.A.
🇺🇸Pensacola, Florida, United States
James A. Haley Veterans Hospital
🇺🇸Tampa, Florida, United States
Northwest Georgia Oncology Centers, a Service of WellStar Cobb Hospital
🇺🇸Marietta, Georgia, United States
Scroll for more (153 remaining)Arizona Oncology Associates, PC - NAHOA🇺🇸Prescott, Arizona, United States