Trial of BMS-986012 in Combination With Platinum and Etoposide

Phase 1

Active, not recruiting

• Conditions: Small Cell Lung Cancer
• Interventions: Drug: BMS-986012; Drug: Etoposide; Drug: Cisplatin; Drug: Platinum; Drug: Carboplatin

• Registration Number: NCT02815592
• Lead Sponsor: Bristol-Myers Squibb

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-06-24
• Study First Submitted QC: 2016-06-27
• Study First Posted: 2016-06-28
• Study Start: 2016-11-28
• Primary Completion: 2019-12-15
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-21
• Last Update Posted: 2024-05-23
• Study Completion: 2024-06-03

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 12

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental Arm 3A	Etoposide	BMS-986012/Platinum/Etoposide
Experimental Arm 1	Cisplatin	BMS-986012/Cisplatin/Etoposide
Experimental Arm 1	Etoposide	BMS-986012/Cisplatin/Etoposide
Experimental Arm 2	Etoposide	BMS-986012/Carboplatin/Etoposide
Experimental Arm 2	Carboplatin	BMS-986012/Carboplatin/Etoposide
Active Comparator Arm 3B	Etoposide	Platinum/Etoposide
Active Comparator Arm 3B	Platinum	Platinum/Etoposide
Experimental Arm 1	BMS-986012	BMS-986012/Cisplatin/Etoposide
Experimental Arm 2	BMS-986012	BMS-986012/Carboplatin/Etoposide
Experimental Arm 3A	BMS-986012	BMS-986012/Platinum/Etoposide
Experimental Arm 3A	Platinum	BMS-986012/Platinum/Etoposide

Primary Outcome Measures

Name	Time	Method
Progression Free Survival	From date of first dose or randomization until date of confirmed disease progression, up to 2 years
Discontinuations due to AEs	Cycle 1, Day 1 up to approximately 26 months.
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.
Number of participants with laboratory toxicity grade shift from baseline	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.

Secondary Outcome Measures

Name	Time	Method
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
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
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	Cycle 1 Day 1 up to 60 days after last dose	Anti-Drug Antibodies

Trial Locations

Locations (4)

Local Institution - 0002; 🇪🇸 Barcelona, Spain

Local Institution - 0004; 🇪🇸 Madrid, Spain

Local Institution - 0010; 🇪🇸 Malaga, Spain

Local Institution - 0003; 🇪🇸 Majadahonda - Madrid, Spain