nivolumab for Non-Small Cell Lung Cancer

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Non-Small Cell Lung Cancernivolumab - Biological
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial will compare two different treatments for locally advanced non-small cell lung cancer.

Eligible Conditions
  • Non-Small Cell Lung Cancer

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Similar Trials

Study Objectives

3 Primary · 34 Secondary · Reporting Duration: Up to 7.5 years

48 Weeks
Proportion of participants without symptom deterioration based on LCS subscale of FACT-L and NSCLC-SAQ
Up to 40 months
Progression-free survival (PFS) by RECIST 1.1 per Blinded Independent Central Review (BICR) for Arm A and Arm B
Progression-free survival (PFS) by RECIST 1.1 per Blinded Independent Central Review (BICR) for Arm B and Arm C
Progression-free survival (PFS) by RECIST 1.1 per investigator assessment
Up to 5 years
Incidence of adverse events (AEs)
Incidence of serious adverse events (SAEs)
Upper arm
Progression-free survival (PFS) by RECIST 1.1 per Blinded Independent Central Review (BICR) for Arm A and Arm C
Up to 55 months
Overall Survival (OS) for Arm A and Arm B
Overall Survival (OS) for Arm B and Arm C
Up to 7 years
DoR by RECIST 1.1 per Investigator assessment
Duration of Response (DoR) by RECIST 1.1 per BICR
Incidence of Adverse Events (AEs)
Incidence of Serious Adverse Events (SAEs)
Incidence of select AEs
ORR by RECIST 1.1 per Investigator assessment
OS for Arm A vs Arm B
OS for Arm B vs Arm C
Objective Response Rate (ORR) by RECIST 1.1 per BICR
Overall Survival (OS) for Arm A vs Arm C
PFS by RECIST 1.1 per BICR for Arm A vs Arm B
PFS by RECIST 1.1 per BICR for Arm B vs Arm C
PFS by RECIST 1.1 per Investigator assessment
Progression-free survival (PFS) by RECIST 1.1 per Blinded Independent Central Review (BICR) for Arm A vs Arm C
Proportion of participants without symptom deterioration based on NSCLC-SAQ
TTR by RECIST 1.1 per Investigator assessment
Time to Death or Distant Metastases (TTDM) by RECIST 1.1 per Investigator assessment
Time to Response (TTR) by RECIST 1.1 per BICR
Up to 7.5 years
CR rate by RECIST 1.1 per investigator assessment
Complete Response Rate (CR rate) by RECIST 1.1 per Blinded Independent Central Review (BICR)
DoR by RECIST 1.1 per investigator assessment
Duration of Response (DoR) by RECIST 1.1 per Blinded Independent Central Review (BICR)
Objective Response Rate (ORR) by RECIST 1.1 per Blinded Independent Central Review (BICR)
Objective response rate (ORR) by RECIST 1.1 per investigator assessment
TTR by RECIST 1.1 per investigator assessment
Time to Response (TTR) by RECIST 1.1 per Blinded Independent Central Review (BICR)
Time to death or distant metastases (TTDM) by RECIST 1.1 per Investigator assessment

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Similar Trials

Trial Design

3 Treatment Groups

Arm B: nivolumab + CCRT
1 of 3
Arm C: CCRT + durvalumab
1 of 3
Arm A: nivolumab + CCRT + ipilimumab
1 of 3

Experimental Treatment

888 Total Participants · 3 Treatment Groups

Primary Treatment: nivolumab · No Placebo Group · Phase 3

Arm B: nivolumab + CCRT
Biological
Experimental Group · 1 Intervention: nivolumab · Intervention Types: Biological
Arm C: CCRT + durvalumab
Biological
Experimental Group · 1 Intervention: durvalumab · Intervention Types: Biological
Arm A: nivolumab + CCRT + ipilimumabExperimental Group · 2 Interventions: nivolumab, ipilimumab · Intervention Types: Biological, Biological
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Durvalumab
FDA approved
Nivolumab
FDA approved
Ipilimumab
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 7.5 years

Who is running the clinical trial?

Bristol-Myers SquibbLead Sponsor
2,501 Previous Clinical Trials
3,927,380 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 3 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have no prior local or systemic anticancer therapy given as primary therapy for locally advanced disease.
You have an Eastern Cooperative Oncology Group (ECOG) performance status of 1 or 2.