A Study of Nivolumab and Ipilimumab in Untreated Patients With Stage 3 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 + CCRT followed by nivolumab + ipilimumab (Arm A) vs CCRT followed by durvalumab (Arm C) in participants with untreated Locally Advanced Non-small Cell Lung Cancer

Trial Description

Primary Outcome:

  • Progression Free Survival (PFS) Assessed by RECIST 1.1 per Blinded Independent Central Review (BICR) for Arm A and Arm C
  • Overall Survival (OS) for Arm A and Arm C
Secondary Outcome:
  • Overall Survival (OS) for Arm B and Arm C
  • Progression Free Survival (PFS) Assessed as per BICR for Arm B and Arm C
  • Objective Response Rate (ORR) and Complete Response Rate Assessed as per BICR
  • Duration of Response (DOR) Assessed as per BICR
  • Time to Response (TTR) Assessed as per BICR
  • Time to Death or Distant Metastases (TTDM) Assessed as per BICR
  • Incidence of Adverse Events (AEs), Serious Adverse Events (SAEs), and select AEs
  • Percentage of Participants Without Meaningful Symptom Deterioration Following 48 Weeks of Maintenance Therapy Based on Lung Cancer Subscale (LCS) of FACT-L and NSCLC-SAQ

View this trial on ClinicalTrials.gov

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Resources

Canadian Cancer Society

These resources are provided in partnership with the Canadian Cancer Society