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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
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
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
GroupInterventionDescription
Atezolizumab + TiragolumabAtezolizumabParticipants will receive atezolizumab and tiragolumab intravenously (IV).
Atezolizumab + TiragolumabTiragolumabParticipants will receive atezolizumab and tiragolumab intravenously (IV).
Atezolizumab + PlaceboAtezolizumabParticipants will receive atezolizumab and placebo IV.
Atezolizumab + PlaceboPlaceboParticipants will receive atezolizumab and placebo IV.
Primary Outcome Measures
NameTimeMethod
Percentage of Participants With Adverse Events (AEs)Up to approximately 2 years
Secondary Outcome Measures
NameTimeMethod
DFS RateYear 3, Year 5, Year 7
Overall Survival (OS)Up to approximately 15 years
Percentage of Participants With Anti-Drug Antibodies (ADAs) to TiragolumabUp 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 AtezolizumabUp to approximately 1 year
Percentage of Participants With Adverse Events (AEs)Up to approximately 15 years
Percentage of Participants With ADAs to AtezolizumabUp to approximately 1 year
Serum Concentration of TiragolumabUp 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

Scroll for more (153 remaining)
Arizona Oncology Associates, PC - NAHOA
🇺🇸Prescott, Arizona, United States

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