Trial in Extensive-Disease Small Cell Lung Cancer (ED-SCLC) Subjects Comparing Ipilimumab Plus Etoposide and Platinum Therapy to Etoposide and Platinum Therapy Alone

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to determine whether the addition of Ipilimumab to Etoposide and Platinum therapy will extend the lives of patients with Extensive-Stage Disease Small Cell Lung Cancer (ED-SCLC) more than Etoposide and Platinum therapy alone.

Official Title
-----------------
Randomized, Multicenter, Double-Blind, Phase 3 Trial Comparing the Efficacy of Ipilimumab Plus Etoposide/Platinum Versus Etoposide/Platinum in Subjects With Newly Diagnosed Extensive-Stage Disease Small Cell Lung Cancer (ED-SCLC)

Conditions
-----------------
Small Cell Lung Carcinoma

Intervention / Treatment
-----------------
* Biological: Ipilimumab
* Biological: Placebo matching Ipilimumab
* Drug: Etoposide
* Drug: Cisplatin
* Drug: Carboplatin


Participation Criteria
=================
Eligibility Criteria
-----------------
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com. Inclusion Criteria: Extensive-Stage Disease Small Cell Lung Cancer (ED-SCLC) Eastern Cooperative Oncology Group (ECOG) of 0 or 1 Exclusion Criteria: Prior systemic therapy for lung cancer Symptomatic Central Nervous System (CNS) metastases History of autoimmune disease

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ipilimumab+Etoposide+Cisplatin/Carboplatin<br>Ipilimumab: IV solution, Intravenous (IV), 10 mg/kg, Once every 3 weeks for 4 doses, then every 12 weeks, Until progression of disease or unacceptable toxicity, or until the maximum treatment period of 3 years is reached Etoposide: IV solution, IV, 100 mg/m2, Days 1-3 every 3 weeks, 4 cycles Cisplatin: IV solution, IV, 75 mg/m2, Once every 3 weeks, 4 doses Carboplatin: IV Solution, IV, Area Under the Curve (AUC) 5, Once every 3 weeks, 4 doses | Biological: Ipilimumab<br> <br> * Other names: BMS-734016;Drug: Etoposide<br> <br> * Other names: Eposin;Drug: Cisplatin<br> <br> * Other names: Platinol;Drug: Carboplatin<br> <br> * Other names: Paraplatin;|
| Placebo Comparator: Placebo matching Ipilimumab+Etoposide+Cisplatin/Carboplatin<br>Placebo matching Ipilimumab: IV solution, IV, 0 mg/kg, Once every 3 weeks for 4 doses, then every 12 weeks, Until progression of disease or unacceptable toxicity, or until the maximum treatment period of 3 years is reached Etoposide: IV solution, IV, 100 mg/m2, Days 1-3 every 3 weeks, 4 cycles Cisplatin: IV solution, IV, 75 mg/m2, Once every 3 weeks, 4 doses Carboplatin: IV Solution, IV, Area Under the Curve (AUC) 5, Once every 3 weeks, 4 doses | Biological: Placebo matching Ipilimumab<br> <br> Drug: Etoposide<br> <br> * Other names: Eposin;Drug: Cisplatin<br> <br> * Other names: Platinol;Drug: Carboplatin<br> <br> * Other names: Paraplatin;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival (OS) in Participants Who Received at Least One Dose of Blinded Study Therapy | Overall Survival was defined as the time from the date of randomization until the date of death from any cause. For participants without documentation of death, OS was censored on the last date the participant was known to be alive. | Randomization until date of death, up to March 2015, approximately 38 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival in All Randomized Participants | Overall Survival was defined as the time from the date of randomization until the date of death from any cause. For participants without documentation of death, OS was censored on the last date the participant was known to be alive. | From randomization until date of death, up to March 2015, approximately 38 months | 
| Progression Free Survival (PFS) Time in Participants Who Have Received at Least One Dose of Blinded Study Therapy | Progression-Free Survival was defined as the time from the date of randomization to the date of progression per modified World Health Organization (mWHO) criteria or death, whichever occured first. A participant who died without reported progression per mWHO criteria was considered progressed on the date of death. For those participants who remained alive and did not progress, 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. | From randomization until disease progression, up to March 2015, approximately 38 months |