A Study of Atezolizumab and Tiragolumab Compared With Durvalumab in Participants With Locally Advanced, Unresectable Stage III Non-Small Cell Lung Cancer (NSCLC)

Official Title

A Phase III, Open-Label, Randomized Study of Atezolizumab and Tiragolumab Compared With Durvalumab in Patients With Locally Advanced, Unresectable Stage III Non-Small Cell Lung Cancer Who Have Not Progressed After Concurrent Platinum-Based Chemoradiation

Summary:

The purpose of this study is to evaluate the efficacy and safety of atezolizumab in combination with tiragolumab compared with durvalumab in participants with locally advanced, unresectable Stage III non-small cell lung cancer (NSCLC) who have received at least two cycles of concurrent platinum-based chemoradiotherapy (CRT) and have not had radiographic disease progression.

Trial Description

Primary Outcome:

• Independent Review Facility (IRF) Assessed Progression Free Survival (PFS)

• Overall Survival (OS)
• Investigator-assessed PFS
• Confirmed Overall Response Rate (ORR)
• Duration of Response (DOR)
• PFS Rates at 12 Months, 18 Months and 24 Months
• OS Rates at 12 Months, 24 Months, 36 Months and 48 Months
• Time to Death or Distant Metastasis (TTDM)
• Time to Confirmed Deterioration (TTCD) Assessed Using European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core (QLQ-C30) Score
• Percentage of Participants With Adverse Events
• Serum Concentration of Tiragolumab
• Serum Concentration of Atezolizumab
• Percentage of Participants With Anti-Drug Antibodies (ADAs) to Tiragolumab
• Percentage of Participants With ADAs to Atezolizumab

View this trial on ClinicalTrials.gov