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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Lung Cancer (NSCLC)

Intervention / Treatment
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* Biological: Paclitaxel
* Biological: Carboplatin
* Biological: Ipilimumab
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1: Carboplatin + Paclitaxel + Ipilimumab<br>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<br> <br> * Other names: BMS-181339;Biological: Carboplatin<br> <br> * Other names: Paraplatin®;Biological: Ipilimumab<br> <br> * Other names: BMS-734016;|
| Experimental: Arm 2: Carboplatin + Paclitaxel + Placebo<br>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<br> <br> * Other names: BMS-181339;Biological: Carboplatin<br> <br> * Other names: Paraplatin®;Other: Placebo<br>* 0.9% sodium chloride injection, USP, or 5% dextrose injection<br>|

What is the study measuring?
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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 |