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

Non-Small Cell Lung Cancer Clinical Trial

— CheckMate 078  

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02613507
• Other study ID #: CA209-078
• Secondary ID: 2015-001893-16
• Status: Completed
• Phase: Phase 3
• Start date: December 11, 2015
• Est. completion date: May 31, 2023

Study information

• Verified date: October 2023
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 639
• Est. completion date: May 31, 2023
• Est. primary completion date: September 15, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-Small Cell Lung Cancer

Intervention

Drug:
• Nivolumab

• Docetaxel

Locations

Country	Name	City	State
China	Local Institution - 0007	Beijing	Beijing
China	Local Institution - 0026	Beijing	Beijing
China	Local Institution - 0029	Beijing
China	Local Institution - 0031	Beijing
China	Local Institution - 0032	Beijing	Beijing
China	Local Institution - 0051	Beijing	Beijing
China	Local Institution - 0006	Changchun	Jilin
China	Local Institution - 0022	Changchun	Jilin
China	Local Institution - 0012	Changsha	Hunan
China	Local Institution - 0023	Changsha	Hunan
China	Local Institution - 0011	Chengdu	Sichuan
China	Local Institution - 0020	Chongqing	Chongqing
China	Local Institution - 0015	Fuzhou	Fujian
China	Local Institution - 0002	Guangzhou	Guangdong
China	Local Institution - 0003	Guangzhou	Guangdong
China	Local Institution - 0008	Hangzhou	Zhejiang
China	Local Institution - 0009	Hangzhou	Zhejiang
China	Local Institution - 0010	Hangzhou	Zhejiang
China	Local Institution - 0034	Nanjing	Jiangsu
China	Local Institution - 0014	Shanghai
China	Local Institution - 0017	Shanghai	Shanghai
China	Local Institution - 0025	Shanghai	Shanghai
China	Local Institution - 0028	Shanghai
China	Local Institution - 0024	Zhengzhou	Henan
Hong Kong	Local Institution - 0049	Hong Kong
Russian Federation	Local Institution - 0039	Chelyabinsk
Russian Federation	Local Institution - 0046	Moscow
Russian Federation	Local Institution - 0052	Moscow
Russian Federation	Local Institution - 0041	St. Petersburg
Russian Federation	Local Institution - 0042	St. Petersburg
Russian Federation	Local Institution - 0040	St.petersburg
Singapore	Local Institution - 0037	Singapore
Singapore	Local Institution - 0048	Singapore

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Countries where clinical trial is conducted

China,  Hong Kong,  Russian Federation,  Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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	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
Secondary	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)
Secondary	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)
Secondary	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)

External Links

•   BMS Clinical Trial Information
•   BMS Clinical Trial Patient Recruiting
•   FDA Safety Alerts and Recalls