Trial of BMS-986012 in Combination With Platinum and Etoposide

Study Overview
=================
Brief Summary
-----------------
The purpose of this this study is to administer BMS-986012 in Combination with Platinum and Etoposide as First-line Therapy in Extensive Small Cell Lung Cancer.

Official Title
-----------------
A Phase 1/2 Randomized Trial of BMS-986012 in Combination With Platinum and Etoposide as First-line Therapy in Extensive-Stage Small Cell Lung Cancer

Conditions
-----------------
Small Cell Lung Cancer

Intervention / Treatment
-----------------
* Drug: BMS-986012
* Drug: Cisplatin
* Drug: Etoposide
* Drug: Platinum
* Drug: Carboplatin


Participation Criteria
=================
Eligibility Criteria
-----------------
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: Male and Females 18 years of age or older Pulmonary SCLC documented by histology or cytology Extensive disease (Stage IV) SCLC Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 Exclusion Criteria: Prior systemic therapy for lung cancer Symptomatic brain metastases Grade 2 peripheral neuropathy Active or chronic infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV Other active malignancies or prior malignancy within 2 years Other protocol defined inclusion/exclusion criteria could apply

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental Arm 1<br>BMS-986012/Cisplatin/Etoposide | Drug: BMS-986012<br> <br> Drug: Cisplatin<br> <br> Drug: Etoposide<br> <br> |
| Experimental: Experimental Arm 2<br>BMS-986012/Carboplatin/Etoposide | Drug: BMS-986012<br> <br> Drug: Etoposide<br> <br> Drug: Carboplatin<br> <br> |
| Experimental: Experimental Arm 3A<br>BMS-986012/Platinum/Etoposide | Drug: BMS-986012<br> <br> Drug: Etoposide<br> <br> Drug: Platinum<br> <br> |
| Active Comparator: Active Comparator Arm 3B<br>Platinum/Etoposide | Drug: Etoposide<br> <br> Drug: Platinum<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with adverse events (AEs) |  | Cycle 1, Day 1 up to approximately 26 months. | 
| Number of participants with serious adverse events (SAEs ) |  | Date of enrollment up to approximately 26 months. | 
| Discontinuations due to AEs |  | Cycle 1, Day 1 up to approximately 26 months. | 
| Number of participants who died due to AEs |  | Cycle 1, Day 1 up to approximately 26 months. | 
| Number of participants with laboratory toxicity grade shift from baseline |  | Cycle 1, Day 1 up to approximately 26 months. | 
| Progression Free Survival |  | From date of first dose or randomization until date of confirmed disease progression, up to 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum observed serum concentration(Cmax) |  | Cycle 1 Day 1 up to 60 days after last dose | 
| Time of maximum observed serum concentration(Tmax) |  | Cycle 1 Day 1 up to 60 days after last dose | 
| Area under the plasma concentration-time curve from time 0 to time of last quantifiable concentration(AUC(0-T)) |  | Cycle 1 Day 1 up to 60 days after last dose | 
| Observed serum concentration at the end of a dosing interval(Ctau) |  | Cycle 1 Day 1 up to 60 days after last dose | 
| Area under the concentration-time curve in 1 dosing interval(AUC(TAU)) |  | Cycle 1 Day 1 up to 60 days after last dose | 
| Characterization of Immunogenicity | Anti-Drug Antibodies | Cycle 1 Day 1 up to 60 days after last dose |