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

Phase 3

Active, not recruiting

• Conditions: Non-small Cell Lung Cancer (NSCLC)
• Interventions: Drug: Atezolizumab; Drug: Tiragolumab; Drug: Placebo

• 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

Study Timeline

• Study First Submitted: 2024-02-12
• Study First Submitted QC: 2024-02-12
• Study First Posted: 2024-02-20
• Study Start: 2024-03-21
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-28
• Last Update Posted: 2025-04-29
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 56

Inclusion Criteria

• 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.

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 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

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

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