Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Efficacy Study of Nivolumab Compared to Docetaxel in Subjects Previously Treated With Advanced or Metastatic Non Small Cell Lung Cancer (CheckMate 078)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02613507
Recruitment Status : Active, not recruiting
First Posted : November 24, 2015
Results First Posted : February 22, 2019
Last Update Posted : March 27, 2020
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

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.

Condition or disease Intervention/treatment Phase
Non-Small Cell Lung Cancer Drug: Nivolumab Drug: Docetaxel Phase 3

Layout table for study information
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 10, 2015
Actual Primary Completion Date : September 15, 2017
Estimated Study Completion Date : February 3, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Arm A: Nivolumab
Nivolumab Intravenous infusion specified dose on specified days
Drug: Nivolumab
Active Comparator: Arm B: Docetaxel
Docetaxel Intravenous infusion specified dose on specified days
Drug: Docetaxel



Primary Outcome Measures :
  1. 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

  2. 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 Outcome Measures :
  1. 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

  2. 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).

  3. 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

  4. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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


Locations
Layout table for location information
China, Beijing
Local Institution
Beijing, Beijing, China, 100021
Local Institution
Beijing, Beijing, China, 100032
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
Chang Chun, 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
China
Local Institution
Beijing, China, 100021
Local Institution
Beijing, China, 100071
Local Institution
Beijing, China
Local Institution
Hangzhou, China, 310022
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
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Layout table for investigator information
Study Director: Bristol Myers Squibb Bristol-Myers Squibb
  Study Documents (Full-Text)

Documents provided by Bristol-Myers Squibb:
Study Protocol  [PDF] December 13, 2017
Statistical Analysis Plan  [PDF] May 2, 2017


Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
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: March 27, 2020
Last Verified: March 2020

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
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