A Study of Nivolumab and Ipilimumab in Untreated Participants With Stage 3 Non-small Cell Lung Cancer (NSCLC) That is Unable or Not Planned to be Removed by Surgery

Official Title

A Phase 3, Randomized, Open Label Study to Compare Nivolumab Plus Concurrent Chemoradiotherapy (CCRT) Followed by Nivolumab Plus Ipilimumab or Nivolumab Plus CCRT Followed by Nivolumab vs CCRT Followed by Durvalumab in Previously Untreated, Locally Advanced Non-small Cell Lung Cancer (LA NSCLC)

Summary:

The primary purpose of the study is to compare the effectiveness of nivolumab plus concurrent chemoradiotherapy (CCRT) followed by nivolumab plus ipilimumab vs CCRT followed by durvalumab in participants with untreated Locally Advanced Non-small Cell Lung Cancer (LA NSCLC).

Trial Description

Primary Outcome:

• Progression-free survival (PFS) by RECIST 1.1 per Blinded Independent Central Review (BICR) for Arm A vs Arm C

• Overall Survival (OS) for Arm A vs Arm C
• PFS by RECIST 1.1 per BICR for Arm B vs Arm C
• OS for Arm B vs Arm C
• PFS by RECIST 1.1 per BICR for Arm A vs Arm B
• OS for Arm A vs Arm B
• Objective Response Rate (ORR) by RECIST 1.1 per BICR
• Duration of Response (DoR) by RECIST 1.1 per BICR
• Time to Response (TTR) by RECIST 1.1 per BICR
• PFS by RECIST 1.1 per Investigator assessment
• ORR by RECIST 1.1 per Investigator assessment
• DoR by RECIST 1.1 per Investigator assessment
• TTR by RECIST 1.1 per Investigator assessment
• Time to Death or Distant Metastases (TTDM) by RECIST 1.1 per Investigator assessment
• Incidence of Adverse Events (AEs)
• Incidence of Serious Adverse Events (SAEs)
• Incidence of select AEs
• Proportion of participants without symptom deterioration based on NSCLC-SAQ

View this trial on ClinicalTrials.gov