Study of BMS-986012 in Subjects With Small Cell Lung Caner

Study Overview
=================
Brief Summary
-----------------
A study to evaluate safety and tolerability of BMS-986012 in patients with small cell lung cancer

Official Title
-----------------
A Phase 1 Study of the Safety and Tolerability of BMS-986012 in Subjects With Small Cell Lung Cancer

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

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com Histological or cytological confirmed small cell lung cancer (SCLC) Eastern Cooperative Oncology Group Performance Status 0-1 at least one measurable lesion that is not amenable to resection. Adequate organ function Exclusion Criteria: Symptomatic central nervous system (CNS) metastases Grade ≥ 2 peripheral neuropathy Uncontrolled or significant cardiac disease Active or chronic infection with Human Immunodeficiency Virus(HIV), Hepatitis B Virus (HBV), or Hepatitis C Virus (HCV) Other protocol defined inclusion/exclusion criteria could apply

Ages Eligible for Study
-----------------
Minimum Age: 20 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dose Escalation Dose 1<br>BMS-986012 Dose Escalation Dose 1 | Drug: BMS-986012<br> <br> |
| Experimental: Dose Escalation Dose 2<br>BMS-986012 Dose Escalation Dose 2 | Drug: BMS-986012<br> <br> |
| Experimental: Chemotherapy Combination<br>BMS-986012 + Cisplatin + Etoposide | Drug: BMS-986012<br> <br> Drug: Cisplatin<br> <br> Drug: Etoposide<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with adverse events (AEs) |  | Up to 2 years | 
| Number of participants with serious adverse events (SAEs ) |  | Up to 2 years | 
| Number of Discontinuations due to AEs |  | Up to 2 years | 
| Number of Deaths due to AEs |  | Up to 2 years | 
| Number of participants with laboratory toxicity grade shift from baseline |  | Up to 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum observed serum concentration (Cmax) |  | Cycle 1(each cycle is 21 days) Day 1 up to 60 days after last dose | 
| Time of maximum observed serum concentration(Tmax) |  | Cycle 1(each cycle is 21 days) 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(each cycle is 21 days) Day 1 up to 60 days after last dose | 
| Observed serum concentration at the end of a dosing interval(Ctau) |  | Cycle 1(each cycle is 21 days) Day 1 up to 60 days after last dose | 
| Area under the concentration-time curve in 1 dosing interval(AUC(TAU)) |  | Cycle 1(each cycle is 21 days) Day 1 up to 60 days after last dose | 
| Characterization of Immunogenicity as measured by Anti-Drug Antibodies (ADA) |  | Cycle 1(each cycle is 21 days) Day 1 up to 60 days after last dose | 
| Best overall response (BOR) |  | Cycle 1(each cycle is 21 days) Day 1 up to approximately 2 years | 
| Duration of response (DOR) |  | Cycle 1(each cycle is 21 days) Day 1 up to approximately 2 years |