Trial of BMS-986012 in Combination With Platinum and Etoposide
Study Details
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.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
Phase 1 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: Experimental Arm 1 BMS-986012/Cisplatin/Etoposide |
Drug: BMS-986012
Drug: Cisplatin
Drug: Etoposide
|
Experimental: Experimental Arm 2 BMS-986012/Carboplatin/Etoposide |
Drug: BMS-986012
Drug: Etoposide
Drug: Carboplatin
|
Experimental: Experimental Arm 3A BMS-986012/Platinum/Etoposide |
Drug: BMS-986012
Drug: Etoposide
Drug: Platinum
|
Active Comparator: Active Comparator Arm 3B Platinum/Etoposide |
Drug: Etoposide
Drug: Platinum
|
Outcome Measures
Primary Outcome Measures
- 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
- 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 [Cycle 1 Day 1 up to 60 days after last dose]
Anti-Drug Antibodies
Eligibility Criteria
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
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Local Institution | Barcelona | Spain | 08035 | |
2 | Local Institution | Madrid | Spain | 28041 | |
3 | Local Institution | Majadahonda - Madrid | Spain | 28222 | |
4 | Local Institution | Malaga | Spain | 29010 |
Sponsors and Collaborators
- Bristol-Myers Squibb
Investigators
- Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- CA001-044
- 2016-001692-67