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Trial of BMS-986012 in Combination With Platinum and Etoposide

Primary Purpose

Small Cell Lung Cancer

Status

Active

Phase

Phase 1

Locations

Spain

Study Type

Interventional

Intervention

BMS-986012

Cisplatin

Etoposide

Platinum

Carboplatin

About this trial

This is an interventional treatment trial for Small Cell Lung Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Local Institution - 0002
Local Institution
Local Institution - 0003
Local Institution - 0010

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Arm Label

Experimental Arm 1

Experimental Arm 2

Experimental Arm 3A

Active Comparator Arm 3B

Arm Description

BMS-986012/Cisplatin/Etoposide

BMS-986012/Carboplatin/Etoposide

BMS-986012/Platinum/Etoposide

Platinum/Etoposide

Outcomes

Primary Outcome Measures

Number of participants with adverse events (AEs)

Number of participants with serious adverse events (SAEs )

Discontinuations due to AEs

Number of participants who died due to AEs

Number of participants with laboratory toxicity grade shift from baseline

Progression Free Survival

Secondary Outcome Measures

Maximum observed serum concentration(Cmax)

Time of maximum observed serum concentration(Tmax)

Area under the plasma concentration-time curve from time 0 to time of last quantifiable concentration(AUC(0-T))

Observed serum concentration at the end of a dosing interval(Ctau)

Area under the concentration-time curve in 1 dosing interval(AUC(TAU))

Characterization of Immunogenicity

Anti-Drug Antibodies

Full Information

NCT ID

NCT02815592

First Posted

June 24, 2016

Last Updated

August 16, 2023

Sponsor

Bristol-Myers Squibb

1. Study Identification

Unique Protocol Identification Number

NCT02815592

Brief Title

Trial of BMS-986012 in Combination With Platinum and Etoposide

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

November 28, 2016 (Actual)

Primary Completion Date

December 15, 2019 (Actual)

Study Completion Date

December 29, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Bristol-Myers Squibb

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Small Cell Lung Cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

12 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Experimental Arm 1

Arm Type

Experimental

Arm Description

BMS-986012/Cisplatin/Etoposide

Arm Title

Experimental Arm 2

Arm Type

Experimental

Arm Description

BMS-986012/Carboplatin/Etoposide

Arm Title

Experimental Arm 3A

Arm Type

Experimental

Arm Description

BMS-986012/Platinum/Etoposide

Arm Title

Active Comparator Arm 3B

Arm Type

Active Comparator

Arm Description

Platinum/Etoposide

Intervention Type

Drug

Intervention Name(s)

BMS-986012

Intervention Type

Drug

Intervention Name(s)

Cisplatin

Intervention Type

Drug

Intervention Name(s)

Etoposide

Intervention Type

Drug

Intervention Name(s)

Platinum

Intervention Type

Drug

Intervention Name(s)

Carboplatin

Primary Outcome Measure Information:

Title

Number of participants with adverse events (AEs)

Time Frame

Cycle 1, Day 1 up to approximately 26 months.

Title

Number of participants with serious adverse events (SAEs )

Time Frame

Date of enrollment up to approximately 26 months.

Title

Discontinuations due to AEs

Time Frame

Cycle 1, Day 1 up to approximately 26 months.

Title

Number of participants who died due to AEs

Time Frame

Cycle 1, Day 1 up to approximately 26 months.

Title

Number of participants with laboratory toxicity grade shift from baseline

Time Frame

Cycle 1, Day 1 up to approximately 26 months.

Title

Progression Free Survival

Time Frame

From date of first dose or randomization until date of confirmed disease progression, up to 2 years

Secondary Outcome Measure Information:

Title

Maximum observed serum concentration(Cmax)

Time Frame