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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
12
Local Institution - 0002
Barcelona, Spain
Local Institution - 0004
Madrid, Spain
Local Institution - 0003
Majadahonda - Madrid, Spain
Local Institution - 0010
Málaga, Spain
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.
Discontinuations due to AEs
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.
Number of participants with laboratory toxicity grade shift from baseline
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
Maximum observed serum concentration(Cmax)
Time frame: Cycle 1 Day 1 up to 60 days after last dose
Time of maximum observed serum concentration(Tmax)
Time frame: 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))
Time frame: Cycle 1 Day 1 up to 60 days after last dose
Observed serum concentration at the end of a dosing interval(Ctau)
Time frame: Cycle 1 Day 1 up to 60 days after last dose
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Area under the concentration-time curve in 1 dosing interval(AUC(TAU))
Time frame: Cycle 1 Day 1 up to 60 days after last dose
Characterization of Immunogenicity
Anti-Drug Antibodies
Time frame: Cycle 1 Day 1 up to 60 days after last dose