Clinical trial NCT02613507: Efficacy Study of Nivolumab Compared to Docetaxel in Subjects Previously Treated With Advanced or Metastatic Non Small Cell Lung Cancer
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Non-Small Cell Lung Cancer
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2015-11-24
Enrollment: 504
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Median Overall Survival
timeFrame: 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)
measure: Overall Survival Rate
timeFrame: 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 outcomes:
measure: Objective Response Rate (ORR)
timeFrame: From date of first dose up to partial or complete response (up to approximately 90 months)
measure: Overall Survival (OS) in Subpopulations
timeFrame: From randomization to the date of death or date participant was last known to be alive (up to approximately 90 months)
measure: Progression Free Survival (PFS)
timeFrame: From the time of randomization to the date of the first documented tumor progression or death due to any cause (up to approximately 90 months)
measure: Progression Free Survival Rate
timeFrame: From the time of randomization up to 6 months
measure: Time to Treatment Failure (TTF)
timeFrame: From randomization up to disease progression, death, or last dose (up to approximately 17 months)
measure: Number of Participants Experiencing Treatment-Related Adverse Events (AEs)
timeFrame: From first dose up to 100 days after last dose (up to 93 months)
measure: Number of Participants Experiencing Treatment-Related Serious Adverse Events (SAEs)
timeFrame: From first dose up to 100 days after last dose (up to 93 months)
measure: Disease Related Symptom Deterioration Rate by Week 12 and Week 24
timeFrame: At Week 12 and Week 24
Other outcomes:
Locations:
city: Beijing
country: China
facility: Local Institution - 0051
state: Beijing
city: Beijing
country: China
facility: Local Institution - 0007
state: Beijing
city: Beijing
country: China
facility: Local Institution - 0032
state: Beijing
city: Beijing
country: China
facility: Local Institution - 0026
state: Beijing
city: Chongqing
country: China
facility: Local Institution - 0020
state: Chongqing
city: Fuzhou
country: China
facility: Local Institution - 0015
state: Fujian
city: Guangzhou
country: China
facility: Local Institution - 0003
state: Guangdong
city: Guangzhou
country: China
facility: Local Institution - 0002
state: Guangdong
city: Zhengzhou
country: China
facility: Local Institution - 0024
state: Henan
city: Changsha
country: China
facility: Local Institution - 0023
state: Hunan
city: Changsha
country: China
facility: Local Institution - 0012
state: Hunan
city: Nanjing
country: China
facility: Local Institution - 0034
state: Jiangsu
city: Changchun
country: China
facility: Local Institution - 0006
state: Jilin
city: Changchun
country: China
facility: Local Institution - 0022
state: Jilin
city: Shanghai
country: China
facility: Local Institution - 0017
state: Shanghai
city: Shanghai
country: China
facility: Local Institution - 0025
state: Shanghai
city: Chengdu
country: China
facility: Local Institution - 0011
state: Sichuan
city: Hangzhou
country: China
facility: Local Institution - 0008
state: Zhejiang
city: Hangzhou
country: China
facility: Local Institution - 0009
state: Zhejiang
city: Hangzhou
country: China
facility: Local Institution - 0010
state: Zhejiang
city: Beijing
country: China
facility: Local Institution - 0031
city: Beijing
country: China
facility: Local Institution - 0029
city: Shanghai
country: China
facility: Local Institution - 0014
city: Shanghai
country: China
facility: Local Institution - 0028
city: Hong Kong
country: Hong Kong
facility: Local Institution - 0049
city: Chelyabinsk
country: Russian Federation
facility: Local Institution - 0039
city: Moscow
country: Russian Federation
facility: Local Institution - 0052
city: Moscow
country: Russian Federation
facility: Local Institution - 0046
city: St. Petersburg
country: Russian Federation
facility: Local Institution - 0042
city: St. Petersburg
country: Russian Federation
facility: Local Institution - 0041
city: St.petersburg
country: Russian Federation
facility: Local Institution - 0040
city: Singapore
country: Singapore
facility: Local Institution - 0048
city: Singapore
country: Singapore
facility: Local Institution - 0037
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol Myers Squibb
role: STUDY_DIRECTOR
References:
citation: 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.