Small Cell Lung Cancer
Conditions
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.
Interventions
Sponsors
Bristol-Myers Squibb
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression Free Survival | From date of first dose or randomization until date of confirmed disease progression, up to 2 years |
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Spain
Outcome results
None listed