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
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 12
- Locations
- 4
- Primary Endpoint
- Discontinuations due to AEs
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Experimental Arm 3A
BMS-986012/Platinum/Etoposide
Intervention: Platinum (Drug)
Experimental Arm 1
BMS-986012/Cisplatin/Etoposide
Intervention: BMS-986012 (Drug)
Experimental Arm 1
BMS-986012/Cisplatin/Etoposide
Intervention: Cisplatin (Drug)
Experimental Arm 1
BMS-986012/Cisplatin/Etoposide
Intervention: Etoposide (Drug)
Experimental Arm 2
BMS-986012/Carboplatin/Etoposide
Intervention: BMS-986012 (Drug)
Experimental Arm 2
BMS-986012/Carboplatin/Etoposide
Intervention: Etoposide (Drug)
Experimental Arm 2
BMS-986012/Carboplatin/Etoposide
Intervention: Carboplatin (Drug)
Experimental Arm 3A
BMS-986012/Platinum/Etoposide
Intervention: BMS-986012 (Drug)
Experimental Arm 3A
BMS-986012/Platinum/Etoposide
Intervention: Etoposide (Drug)
Active Comparator Arm 3B
Platinum/Etoposide
Intervention: Etoposide (Drug)
Active Comparator Arm 3B
Platinum/Etoposide
Intervention: Platinum (Drug)
Outcomes
Primary Outcomes
Discontinuations due to AEs
Time Frame: Cycle 1, Day 1 up to approximately 26 months.
Number of participants with adverse events (AEs)
Time Frame: Cycle 1, Day 1 up to approximately 26 months.
Number of participants with serious adverse events (SAEs )
Time Frame: Date of enrollment up to approximately 26 months.
Number of participants with laboratory toxicity grade shift from baseline
Time Frame: Cycle 1, Day 1 up to approximately 26 months.
Number of participants who died due to AEs
Time Frame: Cycle 1, Day 1 up to approximately 26 months.
Progression Free Survival
Time Frame: From date of first dose or randomization until date of confirmed disease progression, up to 2 years
Secondary Outcomes
- 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)