Efficacy Study of Nivolumab Compared to Docetaxel in Subjects Previously Treated With Advanced or Metastatic Non Small Cell Lung Cancer

Study Overview
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Brief Summary
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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.

Official Title
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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)

Conditions
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Non-Small Cell Lung Cancer

Intervention / Treatment
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* Drug: Nivolumab
* Drug: Docetaxel


Participation Criteria
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Eligibility Criteria
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For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm A: Nivolumab<br>Nivolumab Intravenous infusion specified dose on specified days | Drug: Nivolumab<br> <br> |
| Active Comparator: Arm B: Docetaxel<br>Docetaxel Intravenous infusion specified dose on specified days | Drug: Docetaxel<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Median Overall Survival | 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 | 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) | 
| Overall Survival Rate | 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. | 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) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective Response Rate | Investigator assessed ORR was defined as the number of subjects whose best objective response (BOR) was a confirmed complete response (CR) or confirmed partial response (PR), as determined by the investigator, divided by the number of randomized subjects | From date of first dose up to assessed from December 2015 to Oct 2017 approximately 22 months | 
| Overall Survival in Subpopulations | 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. Test stratified by histology (SQ vs NSQ), PD-L1 status at 1%expression level (positive vs negative/unevaluable). | 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) | 
| Median Progression Free Survival (PFS) | PFS was defined as the time from randomization to the date of the first documented tumor progression as determined by investigators per RECIST 1.1, or death due to any cause. Clinical deterioration in the absence of unequivocal evidence of progression (per RECIST 1.1) was not considered progression for purposes of determining PFS. Subjects who died without a reported prior progression were considered to have progressed on the date of their death. Subjects who did not have disease progression or die were censored on the date of their last evaluable tumor assessment. Subjects who did not have any on study tumor assessments and did not die were censored at the randomization date. Subjects who started any subsequent anti-cancer therapy (including on-treatment palliative RT of non-target bone lesions, skin lesions or CNS lesions) without a prior reported progression were censored at the last evaluable tumor assessment prior to or on initiation of the subsequent anti-cancer therapy | From the time of randomization to the date of the first documented tumor progression or death due to any cause (assessed from December 2015 to Oct 2017 approximately 22 months) | 
| Progression Free Survival Rate | Clinical deterioration in the absence of unequivocal evidence of progression (per RECIST 1.1) is not considered progression for purposes of determining PFS. Subjects who die without a reported prior progression will be considered to have progressed on the date of their death. Subjects who did not have disease progression or die will be censored on the date of their last evaluable tumor assessment. Subjects who did not have any on study tumor assessments and did not die will be censored at the randomization date. Subjects who started any subsequent anti-cancer therapy without a prior reported progression will be censored at the last evaluable tumor assessment prior to or on initiation of the subsequent anti-cancer therapy. Six month progression-free survival rate as estimated using the Kaplan-Meier method | From the time of randomization to the date of the first documented tumor progression or death due to any cause (assessed from December 2015 to Oct 2017 approximately 22 months) |