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

• 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: Bristol-Myers Squibb
• Information provided by (Responsible Party): Bristol-Myers Squibb

Study Description

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

Study Design

• 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

Arms and Interventions

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

Outcome Measures

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

Eligibility Criteria

• 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

Contacts and Locations

Locations

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

• 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

More Information

Additional Information:

BMS Clinical Trial Information  BMS Clinical Trial Patient Recruiting  Investigator Inquiry Form  FDA Safety Alerts and Recalls 

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Wu YL, Lu S, Cheng Y, Zhou C, Wang J, Mok T, Zhang L, Tu HY, Wu L, Feng J, Zhang Y, Luft AV, Zhou J, Ma Z, Lu Y, Hu C, Shi Y, Baudelet C, Cai J, Chang J. Nivolumab Versus Docetaxel in a Predominantly Chinese Patient Population With Previously Treated Advanced NSCLC: CheckMate 078 Randomized Phase III Clinical Trial. J Thorac Oncol. 2019 May;14(5):867-875. doi: 10.1016/j.jtho.2019.01.006. Epub 2019 Jan 17.

• 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
• Results First Posted: February 22, 2019
• Last Update Posted: March 27, 2020
• Last Verified: March 2020

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant 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