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

July 22, 2019 updated by: Bristol-Myers Squibb

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

342

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Beijing, China, 100071
        • Local Institution
      • Chongqing, China, 400038
        • Local Institution
      • Fuzhou, China
        • Local Institution
      • Kunming, China
        • Local Institution
      • Shanghai, China, 200030
        • Local Institution
    • Beijing
      • Beijing, Beijing, China, 100032
        • Local Institution
      • Beijing, Beijing, China, 100042
        • Local Institution
    • Chongqing
      • Chongqing, Chongqing, China, 400042
        • Local Institution
    • Fujian
      • Fuzhou, Fujian, China, 350025
        • Local Institution
    • Guangdong
      • Guangzhou, Guangdong, China, 510080
        • Local Institution
      • Guangzhou, Guangdong, China, 510060
        • Local Institution
      • Guangzhou, Guangdong, China, 510120
        • Local Institution
      • Shantou, Guangdong, China, 515041
        • Local Institution
    • Henan
      • Zhengzhou, Henan, China
        • Local Institution
    • Hunan
      • Changsha, Hunan, China, 410008
        • Local Institution
      • Changsha, Hunan, China
        • Local Institution
    • Jiangsu
      • Nanjing, Jiangsu, China, 210000
        • Local Institution
      • Nanjing, Jiangsu, China, 210002
        • Local Institution
    • Jilin
      • Chang Chun, Jilin, China, 130012
        • Local Institution
      • Changchun, Jilin, China, 130021
        • Local Institution
    • Shan3xi
      • Xi'an, Shan3xi, China, 710038
        • Local Institution
      • Xi'an, Shan3xi, China, 710061
        • Local Institution
    • Shanghai
      • Shanghai, Shanghai, China, 200025
        • Local Institution
      • Shanghai, Shanghai, China, 200032
        • Local Institution
    • Sichuan
      • Chengdu, Sichuan, China, 610041
        • Local Institution
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310003
        • Local Institution
      • Hangzhou, Zhejiang, China, 310022
        • Local Institution
      • Hangzhou, Zhejiang, China, 310016
        • Local Institution
      • Hangzhou, Zhejiang, China, 310009
        • Local Institution
  • Germany
      • Berlin, Germany, 13125
        • Local Institution
      • Halle, Germany, 06120
        • Local Institution
      • Hamburg, Germany, 21075
        • Local Institution
      • Leipzig, Germany, 04357
        • Local Institution
      • Loewenstein, Germany, 74245
        • Local Institution
      • Mainz, Germany, 55131
        • Local Institution
  • Hungary
      • Budapest, Hungary, 1125
        • Pulmonologiai Klinika
      • Deszk, Hungary, 6772
        • Csongrád Megyei Önkormányzat Mellkasi Betegségek Szakkórháza
      • Torokbalint, Hungary, 2045
        • Törökbálinti Tüdőgyógyintézet
  • Korea, Republic of
      • Seoul, Korea, Republic of, 06351
        • Local Institution
      • Seoul, Korea, Republic of, 03722
        • Local Institution
      • Seoul, Korea, Republic of, 05368
        • Local Institution
    • Chungcheonbuk-do
      • Cheongju-si, Chungcheonbuk-do, Korea, Republic of, 28644
        • Local Institution
    • Gyeonggi-do
      • Suwon-si, Gyeonggi-do, Korea, Republic of, 16499
        • Local Institution
    • Jeonnam
      • Hwasun-gun, Jeonnam, Korea, Republic of, 58128
        • Local Institution
  • Poland
      • Elblag, Poland, 82-300
        • Oddzial Onkologiczny
      • Poznan, Poland, 60-569
        • Oddzial Chemioterapii
      • Warszawa, Poland, 02-781
        • Klinika Nowotworow Pluca i Klatki Piersiowej
  • Singapore
      • Singapore, Singapore, 308433
        • Local Institution
      • Singapore, Singapore, 169610
        • Local Institution

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / 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: Ipilimumab
Other Names:
  • BMS-734016
  • MDX-010
Biological: Paclitaxel
Other Names:
  • BMS-181339
  • Taxol®
Biological: Carboplatin
Other Names:
  • Paraplatin®
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:
  • BMS-181339
  • Taxol®
Biological: Carboplatin
Other Names:
  • Paraplatin®
Other: Placebo
0.9% sodium chloride injection, USP, or 5% dextrose injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Approximately 43 months post study start

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Approximately 43 months post study start
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.
Approximately 43 months post study start

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bristol-Myers Squibb

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 13, 2014

Primary Completion (Actual)

May 3, 2018

Study Completion (Actual)

May 3, 2018

Study Registration Dates

First Submitted

October 14, 2014

First Submitted That Met QC Criteria

October 28, 2014

First Posted (Estimate)

October 31, 2014

Study Record Updates

Last Update Posted (Actual)

August 28, 2019

Last Update Submitted That Met QC Criteria

July 22, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CA184-153
  • 2014-002604-25 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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