An Open-label Randomized Multinational Phase 3 Trial of Nivolumab Versus Docetaxel in Previously Treated Subjects With Advanced or Metastatic Non-small Cell Lung Cancer (CheckMate 078: CHECKpoint Pathway and nivoluMAb Clinical Trial Evaluation 078)
Overview
- Phase
- Phase 3
- Intervention
- Nivolumab
- Conditions
- Non-Small Cell Lung Cancer
- Sponsor
- Bristol-Myers Squibb
- Enrollment
- 504
- Locations
- 33
- Primary Endpoint
- Median Overall Survival
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
The purpose of this study is to determine whether Nivolumab improves life expectancy compared to Docetaxel in Subjects with Advanced or Metastatic Non-small Cell Lung Cancer who have failed prior platinum-based doublet chemotherapy.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Disease progression experienced during or after one prior platinum containing doublet chemotherapy
- •Stage IIIb/IV or recurrent disease
- •Male and Female ≥ 18 years of age
- •Measurable disease per RECIST 1.1
- •Performance Status ≤ 1
Exclusion Criteria
- •History of Carcinomatous meningitis
- •Active Central nervous system (CNS) metastases
- •History of auto immune diseases
- •Prior treatment with Docetaxel
- •Prior treatment with ipilimumab or any drug targeting T-Cell costimulation or checkpoint pathways
Arms & Interventions
Arm A: Nivolumab
Nivolumab Intravenous infusion specified dose on specified days
Intervention: Nivolumab
Arm B: Docetaxel
Docetaxel Intravenous infusion specified dose on specified days
Intervention: Docetaxel
Outcomes
Primary Outcomes
Median Overall Survival
Time Frame: From randomization to the date of death or date participant was last known to be alive (assessed from December 2015 to Oct 2017 approximately 22 months)
OS was defined as the time between the date of randomization and the date of death. For subjects without documentation of death, OS was censored on the last date the subject was known to be alive
Overall Survival Rate
Time Frame: From first dose to the date of death or date participant was last known to be alive (assessed from December 2015 to Oct 2017 approximately 22 months)
OS was defined as the time between the date of randomization and the date of death. For subjects without documentation of death, OS was censored on the last date the subject was known to be alive. Rates provided are Kaplan-Meier estimates.
Secondary Outcomes
- Objective Response Rate (ORR)(From date of first dose up to partial or complete response (up to approximately 90 months))
- Overall Survival (OS) in Subpopulations(From randomization to the date of death or date participant was last known to be alive (up to approximately 90 months))
- Progression Free Survival (PFS)(From the time of randomization to the date of the first documented tumor progression or death due to any cause (up to approximately 90 months))
- Progression Free Survival Rate(From the time of randomization up to 6 months)
- Time to Treatment Failure (TTF)(From randomization up to disease progression, death, or last dose (up to approximately 17 months))
- Number of Participants Experiencing Treatment-Related Adverse Events (AEs)(From first dose up to 100 days after last dose (up to 93 months))
- Number of Participants Experiencing Treatment-Related Serious Adverse Events (SAEs)(From first dose up to 100 days after last dose (up to 93 months))
- Disease Related Symptom Deterioration Rate by Week 12 and Week 24(At Week 12 and Week 24)