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Phase 3 Trial in Squamous Non Small Cell Lung Cancer Subjects Comparing Ipilimumab Plus Paclitaxel and Carboplatin Versus Placebo Plus Paclitaxel and Carboplatin

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02279732
Recruitment Status : Completed
First Posted : October 31, 2014
Results First Posted : August 28, 2019
Last Update Posted : August 28, 2019
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Brief Summary:
The purpose of the study is to determine whether Ipilimumab plus Paclitaxel and Carboplatin will extend the life of patients with squamous only non small cell lung cancer more than placebo plus Paclitaxel and Carboplatin.

Condition or disease Intervention/treatment Phase
Lung Cancer (NSCLC) Biological: Paclitaxel Biological: Carboplatin Biological: Ipilimumab Other: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 342 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Multicenter, Double-Blind, Multinational, Phase 3 Trial Comparing the Efficacy of Ipilimumab in Addition to Paclitaxel and Carboplatin Versus Placebo in Addition to Paclitaxel and Carboplatin in Subjects With Stage IV/Recurrent Non-Small Cell Lung Cancer (NSCLC) With Squamous Histology
Actual Study Start Date : October 13, 2014
Actual Primary Completion Date : May 3, 2018
Actual Study Completion Date : May 3, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Arm Intervention/treatment
Experimental: 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

Biological: Paclitaxel
Other Names:
  • Taxol®
  • BMS-181339

Biological: Carboplatin
Other Name: Paraplatin®

Biological: Ipilimumab
Other Names:
  • MDX-010
  • BMS-734016

Experimental: 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

Biological: Paclitaxel
Other Names:
  • Taxol®
  • BMS-181339

Biological: Carboplatin
Other Name: Paraplatin®

Other: Placebo
0.9% sodium chloride injection, USP, or 5% dextrose injection




Primary Outcome Measures :
  1. Overall Survival (OS) of All Randomized Participants Who Received at Least One Dose of Blinded Study Therapy [ Time Frame: Approximately 43 months post study start ]
    OS is defined as the time from the date of randomization until the date of death. For those participants who have not died, OS was censored on the last date the participant was known to be alive.


Secondary Outcome Measures :
  1. Overall Survival of All Randomized Participants [ Time Frame: Approximately 43 months post study start ]
    OS is defined as the time from the date of randomization until the date of death. For those participants who have not died, OS was censored on the last date the participant was known to be alive.

  2. Progression-free Survival (PFS) Among All Randomized Particiapants Who Received at Least One Dose of Blinded Study Therapy Using Modified World Health Organization (mWHO) Criteria [ Time Frame: Approximately 43 months post study start ]
    PFS is defined as the time between the date of randomization and the date of progression per mWHO criteria or death, whichever occurs first. A participant who died without reported progression per mWHO criteria was considered to have progressed on the date of death. For those participants who remained alive and had not progressed, PFS was censored on the date of last evaluable tumor assessment. For those participants who remained alive and had no recorded post-baseline tumor assessment, PFS was censored on the day of randomization.



Information from the National Library of Medicine

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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:

  • Subjects with NSCLC of predominantly squamous histology documented by histology or cytology from brushing, washing or needle aspiration of a defined lesion but not from sputum cytology alone
  • 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:

  • Brain metastases
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02279732


Locations
Show Show 49 study locations
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  Study Documents (Full-Text)

Documents provided by Bristol-Myers Squibb:
Study Protocol  [PDF] December 11, 2014
Statistical Analysis Plan  [PDF] December 11, 2014


Additional Information:
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Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT02279732    
Other Study ID Numbers: CA184-153
2014-002604-25 ( EudraCT Number )
First Posted: October 31, 2014    Key Record Dates
Results First Posted: August 28, 2019
Last Update Posted: August 28, 2019
Last Verified: July 2019
Additional relevant MeSH terms:
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Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Paclitaxel
Albumin-Bound Paclitaxel
Carboplatin
Ipilimumab
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Immunological