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 plus concurrent chemoradiotherapy (CCRT) followed by nivolumab plus 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) 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:
  • Progression-free survival (PFS) by RECIST 1.1 per Blinded Independent Central Review (BICR) for Arm B and Arm C
  • Overall Survival (OS) for Arm B and Arm C
  • Progression-free survival (PFS) by RECIST 1.1 per Blinded Independent Central Review (BICR) for Arm A and Arm B
  • Overall Survival (OS) for Arm A and Arm B
  • Objective Response Rate (ORR) by RECIST 1.1 per Blinded Independent Central Review (BICR)
  • Complete Response Rate (CR rate) by RECIST 1.1 per Blinded Independent Central Review (BICR)
  • Duration of Response (DoR) by RECIST 1.1 per Blinded Independent Central Review (BICR)
  • Time to Response (TTR) by RECIST 1.1 per Blinded Independent Central Review (BICR)
  • Progression-free survival (PFS) by RECIST 1.1 per investigator assessment
  • Objective response rate (ORR) by RECIST 1.1 per investigator assessment
  • CR rate 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)
  • Proportion of participants without symptom deterioration based on LCS subscale of FACT-L and NSCLC-SAQ

View this trial on ClinicalTrials.gov

Interested in this trial?

Print this page and take it to your doctor to discuss your eligibilty and treatment options. Only your doctor can refer you to a clinical trial.

Resources

Canadian Cancer Society

These resources are provided in partnership with the Canadian Cancer Society