Efficacy Study of Nivolumab Compared to Docetaxel in Subjects Previously Treated With Advanced or Metastatic Non Small Cell Lung Cancer (CheckMate 078)
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ClinicalTrials.gov Identifier: NCT02613507 |
Recruitment Status :
Active, not recruiting
First Posted : November 24, 2015
Results First Posted : February 22, 2019
Last Update Posted : May 3, 2022
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Non-Small Cell Lung Cancer | Drug: Nivolumab Drug: Docetaxel | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 639 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | 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) |
Actual Study Start Date : | December 11, 2015 |
Actual Primary Completion Date : | September 15, 2017 |
Estimated Study Completion Date : | February 1, 2023 |

Arm | Intervention/treatment |
---|---|
Experimental: Arm A: Nivolumab
Nivolumab Intravenous infusion specified dose on specified days
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Drug: Nivolumab |
Active Comparator: Arm B: Docetaxel
Docetaxel Intravenous infusion specified dose on specified days
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Drug: Docetaxel |
- 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.
- Objective Response Rate [ Time Frame: From date of first dose up to assessed from December 2015 to Oct 2017 approximately 22 months ]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
- Overall Survival in Subpopulations [ 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. Test stratified by histology (SQ vs NSQ), PD-L1 status at 1%expression level (positive vs negative/unevaluable).
- Median Progression Free Survival (PFS) [ Time Frame: 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) ]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
- Progression Free Survival Rate [ Time Frame: 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) ]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

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02613507
China, Beijing | |
Local Institution | |
Beijing, Beijing, China, 100021 | |
Local Institution | |
Beijing, Beijing, China, 100032 | |
Local Institution | |
Beijing, Beijing, China, 100071 | |
Local Institution | |
Beijing, Beijing, China, 100853 | |
China, Chongqing | |
Local Institution | |
Chongqing, Chongqing, China, 400042 | |
China, Fujian | |
Local Institution | |
Fuzhou, Fujian, China, 350025 | |
China, Guangdong | |
Local Institution | |
Guangzhou, Guangdong, China, 510060 | |
Local Institution | |
Guangzhou, Guangdong, China, 510080 | |
China, Henan | |
Local Institution | |
Zhengzhou, Henan, China, 450008 | |
China, Hunan | |
Local Institution | |
Changsha, Hunan, China, 410008 | |
Local Institution | |
Changsha, Hunan, China, 410013 | |
China, Jiangsu | |
Local Institution | |
Nanjing, Jiangsu, China, 210000 | |
China, Jilin | |
Local Institution | |
Changchun, Jilin, China, 130012 | |
Local Institution | |
Changchun, Jilin, China, 130021 | |
China, Shanghai | |
Local Institution | |
Shanghai, Shanghai, China, 200032 | |
Local Institution | |
Shanghai, Shanghai, China, 200433 | |
China, Sichuan | |
Local Institution | |
Chengdu, Sichuan, China, 610041 | |
China, Zhejiang | |
Local Institution | |
Hangzhou, Zhejiang, China, 310003 | |
Local Institution | |
Hangzhou, Zhejiang, China, 310016 | |
Local Institution | |
Hangzhou, Zhejiang, China | |
China | |
Local Institution | |
Beijing, China, 100021 | |
Local Institution | |
Beijing, China | |
Local Institution | |
Shanghai, China, 200030 | |
Hong Kong | |
Local Institution | |
Hong Kong, Hong Kong | |
Russian Federation | |
Local Institution | |
Chelyabinsk, Russian Federation, 454048 | |
Local Institution | |
Moscow, Russian Federation, 105229 | |
Local Institution | |
Moscow, Russian Federation, 121309 | |
Local Institution | |
St. Petersburg, Russian Federation, 194291 | |
Local Institution | |
St. Petersburg, Russian Federation, 198255 | |
Local Institution | |
St.petersburg, Russian Federation, 197758 | |
Singapore | |
Local Institution | |
Singapore, Singapore, 119228 | |
Local Institution | |
Singapore, Singapore, 308433 |
Study Director: | Bristol Myers Squibb | Bristol-Myers Squibb |
Documents provided by Bristol-Myers Squibb:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Bristol-Myers Squibb |
ClinicalTrials.gov Identifier: | NCT02613507 |
Other Study ID Numbers: |
CA209-078 2015-001893-16 ( EudraCT Number ) |
First Posted: | November 24, 2015 Key Record Dates |
Results First Posted: | February 22, 2019 |
Last Update Posted: | May 3, 2022 |
Last Verified: | April 2022 |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Lung Neoplasms Carcinoma, Non-Small-Cell Lung Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases Respiratory Tract Diseases Carcinoma, Bronchogenic Bronchial Neoplasms |
Docetaxel Nivolumab Antineoplastic Agents Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action Antineoplastic Agents, Immunological Immune Checkpoint Inhibitors |