Phase 3 Trial in Squamous Non Small Cell Lung Cancer Subjects Comparing Ipilimumab Plus Paclitaxel and Carboplatin Versus Placebo Plus Paclitaxel and Carboplatin
NCT ID: NCT02279732
Last Updated: 2019-08-28
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
342 participants
INTERVENTIONAL
2014-10-13
2018-05-03
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Arm 1: Carboplatin + Paclitaxel + Ipilimumab
Paclitaxel 175 mg/m² IV Solution Every 3 weeks during induction and every 12 weeks during maintenance until disease progression declared by modified WHO (mWHO)
Carboplatin Area Under the Curve (AUC6) IV Solution Every 3 weeks during induction and every 12 weeks during maintenance until disease progression declared by mWHO
Ipilimumab 10 mg/kg IV Solution Every 3 weeks during induction and every 12 weeks during maintenance until disease progression declared by mWHO
Paclitaxel
Carboplatin
Ipilimumab
Arm 2: Carboplatin + Paclitaxel + Placebo
Carboplatin AUC6 IV Solution Every 3 weeks during induction and every 12 weeks during maintenance until disease progression declared by mWHO
Paclitaxel 175 mg/m² IV Solution Every 3 weeks during induction and every 12 weeks during maintenance until disease progression declared by mWHO
Placebo IV Solution Every 3 weeks during induction and every 12 weeks during maintenance until disease progression declared by mWHO
Paclitaxel
Carboplatin
Placebo
0.9% sodium chloride injection, USP, or 5% dextrose injection
Interventions
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Paclitaxel
Carboplatin
Ipilimumab
Placebo
0.9% sodium chloride injection, USP, or 5% dextrose injection
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Stage IV or Recurrent NSCLC (per the 7th International Association for the Study of Lung Cancer (IASLC) classification)
* At least 1 measurable tumor lesion, as defined by mWHO criteria, that is not located in a previously irradiated area
* Eastern Cooperative Oncology Group (ECOG) performance status ≤1
Exclusion Criteria
* Malignant pleural effusion that is recurrent
* Documented history of severe autoimmune or immune mediated symptomatic disease that required prolonged (more than 2 months) systemic immunosuppressive (ie, steroids) treatment
18 Years
ALL
No
Sponsors
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Bristol-Myers Squibb
INDUSTRY
Responsible Party
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Principal Investigators
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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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Local Institution
Beijing, Beijing Municipality, China
Local Institution
Beijing, Beijing Municipality, China
Local Institution
Chongqing, Chongqing Municipality, China
Local Institution
Fuzhou, Fujian, China
Local Institution
Guangzhou, Guangdong, China
Local Institution
Guangzhou, Guangdong, China
Local Institution
Guangzhou, Guangdong, China
Local Institution
Shantou, Guangdong, China
Local Institution
Zhengzhou, Henan, China
Local Institution
Changsha, Hunan, China
Local Institution
Changsha, Hunan, China
Local Institution
Nanjing, Jiangsu, China
Local Institution
Nanjing, Jiangsu, China
Local Institution
Changchun, Jilin, China
Local Institution
Changchun, Jilin, China
Local Institution
Xi'an, Shan3xi, China
Local Institution
Xi'an, Shan3xi, China
Local Institution
Shanghai, Shanghai Municipality, China
Local Institution
Shanghai, Shanghai Municipality, China
Local Institution
Chengdu, Sichuan, China
Local Institution
Hangzhou, Zhejiang, China
Local Institution
Hangzhou, Zhejiang, China
Local Institution
Hangzhou, Zhejiang, China
Local Institution
Hangzhou, Zhejiang, China
Local Institution
Beijing, , China
Local Institution
Chongqing, , China
Local Institution
Fuzhou, , China
Local Institution
Kunming, , China
Local Institution
Shanghai, , China
Local Institution
Berlin, , Germany
Local Institution
Halle, , Germany
Local Institution
Hamburg, , Germany
Local Institution
Leipzig, , Germany
Local Institution
Löwenstein, , Germany
Local Institution
Mainz, , Germany
Pulmonologiai Klinika
Budapest, , Hungary
Csongrad Megyei Onkormanyzat Mellkasi Betegsegek Szakkorhaza
Deszk, , Hungary
Torokbalinti Tudogyogyintezet
Törökbálint, , Hungary
Oddzial Onkologiczny
Elblag, , Poland
Oddzial Chemioterapii
Poznan, , Poland
Klinika Nowotworow Pluca i Klatki Piersiowej
Warsaw, , Poland
Local Institution
Singapore, , Singapore
Local Institution
Singapore, , Singapore
Local Institution
Cheongju-si, Chungcheonbuk-do, South Korea
Local Institution
Suwon, Gyeonggi-do, South Korea
Local Institution
Hwasun-gun, Jeollanam-do, South Korea
Local Institution
Seoul, , South Korea
Local Institution
Seoul, , South Korea
Local Institution
Seoul, , South Korea
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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BMS Clinical Trial Information
BMS Clinical Trial Patient Recruiting
Investigator Inquiry Form
Other Identifiers
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2014-002604-25
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CA184-153
Identifier Type: -
Identifier Source: org_study_id
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