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

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: Lung Cancer (NSCLC)
• Intervention / Treatment: Biological: Ipilimumab; Biological: Paclitaxel; Biological: Carboplatin; Other: Placebo

• Study Type: Interventional
• Enrollment (Actual): 342
• Phase: Phase 3

Contacts and Locations

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

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

How is the study designed?

Design Details

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

Number of Arms

2

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	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	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	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

• Sponsor: Bristol-Myers Squibb

Publications and helpful links

Helpful Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting

Study record dates

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: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Antineoplastic Agents, Phytogenic; Antineoplastic Agents, Immunological; Immune Checkpoint Inhibitors; Carboplatin; Paclitaxel; Ipilimumab
• Other Study ID Numbers: CA184-153; 2014-002604-25 (EudraCT Number)