Efficacy Study of Nivolumab Compared to Docetaxel in Subjects Previously Treated With Advanced or Metastatic Non Small Cell Lung Cancer
NCT ID: NCT02613507
Last Updated: 2024-11-19
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
504 participants
INTERVENTIONAL
2015-12-11
2023-11-24
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Study of Nivolumab in Advanced Non-Small Cell Lung Cancer (NSCLC)
NCT02574078
A Study of Nivolumab +/- Docetaxel in Patients Previously Treated With Advanced or Metastatic NSCLC
NCT04023617
Study of BMS-936558 (Nivolumab) Compared to Docetaxel in Previously Treated Advanced or Metastatic Squamous Cell Non-small Cell Lung Cancer (NSCLC) (CheckMate 017)
NCT01642004
Nivolumab After Cyclophosphamide and Doxorubicin Induction Therapy in NSCLC With PD-L1<10%
NCT03808480
Study of BMS-936558 (Nivolumab) Compared to Docetaxel in Previously Treated Metastatic Non-squamous NSCLC
NCT01673867
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Arm A: Nivolumab
Nivolumab Intravenous infusion specified dose on specified days
Nivolumab
Arm B: Docetaxel
Docetaxel Intravenous infusion specified dose on specified days
Docetaxel
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Nivolumab
Docetaxel
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Stage IIIb/IV or recurrent disease
* Male and Female ≥ 18 years of age
* Measurable disease per RECIST 1.1
* Performance Status ≤ 1
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Bristol-Myers Squibb
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Bristol Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Local Institution - 0051
Beijing, Beijing Municipality, China
Local Institution - 0007
Beijing, Beijing Municipality, China
Local Institution - 0032
Beijing, Beijing Municipality, China
Local Institution - 0026
Beijing, Beijing Municipality, China
Local Institution - 0020
Chongqing, Chongqing Municipality, China
Local Institution - 0015
Fuzhou, Fujian, China
Local Institution - 0003
Guangzhou, Guangdong, China
Local Institution - 0002
Guangzhou, Guangdong, China
Local Institution - 0024
Zhengzhou, Henan, China
Local Institution - 0023
Changsha, Hunan, China
Local Institution - 0012
Changsha, Hunan, China
Local Institution - 0034
Nanjing, Jiangsu, China
Local Institution - 0006
Changchun, Jilin, China
Local Institution - 0022
Changchun, Jilin, China
Local Institution - 0017
Shanghai, Shanghai Municipality, China
Local Institution - 0025
Shanghai, Shanghai Municipality, China
Local Institution - 0011
Chengdu, Sichuan, China
Local Institution - 0008
Hangzhou, Zhejiang, China
Local Institution - 0009
Hangzhou, Zhejiang, China
Local Institution - 0010
Hangzhou, Zhejiang, China
Local Institution - 0031
Beijing, , China
Local Institution - 0029
Beijing, , China
Local Institution - 0014
Shanghai, , China
Local Institution - 0028
Shanghai, , China
Local Institution - 0049
Hong Kong, , Hong Kong
Local Institution - 0039
Chelyabinsk, , Russia
Local Institution - 0052
Moscow, , Russia
Local Institution - 0046
Moscow, , Russia
Local Institution - 0042
Saint Petersburg, , Russia
Local Institution - 0040
Saint Petersburg, , Russia
Local Institution - 0041
Saint Petersburg, , Russia
Local Institution - 0048
Singapore, , Singapore
Local Institution - 0037
Singapore, , Singapore
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Hu S, Tang Z, Harrison JP, Hertel N, Penrod JR, May JR, Juarez-Garcia A, Holdgate O. Economic Evaluation of Nivolumab Versus Docetaxel for the Treatment of Advanced Squamous and Non-squamous Non-small Cell Lung Cancer After Prior Chemotherapy in China. Pharmacoecon Open. 2023 Mar;7(2):273-284. doi: 10.1007/s41669-022-00383-x. Epub 2023 Mar 10.
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.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
Access external resources that provide additional context or updates about the study.
BMS Clinical Trial Information
BMS Clinical Trial Patient Recruiting
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CA209-078
Identifier Type: -
Identifier Source: org_study_id
2015-001893-16
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.