Small Cell Lung Cancer
Conditions
Brief summary
A study to evaluate safety and tolerability of BMS-986012 in patients with small cell lung cancer
Interventions
Sponsors
Bristol-Myers Squibb
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com * Histological or cytological confirmed small cell lung cancer (SCLC) * Eastern Cooperative Oncology Group Performance Status 0-1 * at least one measurable lesion that is not amenable to resection. * Adequate organ function
Exclusion criteria
* Symptomatic central nervous system (CNS) metastases * Grade ≥ 2 peripheral neuropathy * Uncontrolled or significant cardiac disease * Active or chronic infection with Human Immunodeficiency Virus(HIV), Hepatitis B Virus (HBV), or Hepatitis C Virus (HCV) Other protocol defined inclusion/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of participants with adverse events (AEs) | Up to 2 years |
| Number of participants with serious adverse events (SAEs ) | Up to 2 years |
| Number of Discontinuations due to AEs | Up to 2 years |
| Number of Deaths due to AEs | Up to 2 years |
| Number of participants with laboratory toxicity grade shift from baseline | Up to 2 years |
Secondary
| Measure | Time frame |
|---|---|
| Characterization of Immunogenicity as measured by Anti-Drug Antibodies (ADA) | Cycle 1(each cycle is 21 days) Day 1 up to 60 days after last dose |
| Maximum observed serum concentration (Cmax) | Cycle 1(each cycle is 21 days) Day 1 up to 60 days after last dose |
| Duration of response (DOR) | Cycle 1(each cycle is 21 days) Day 1 up to approximately 2 years |
| Best overall response (BOR) | Cycle 1(each cycle is 21 days) Day 1 up to approximately 2 years |
| Time of maximum observed serum concentration(Tmax) | Cycle 1(each cycle is 21 days) 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(each cycle is 21 days) Day 1 up to 60 days after last dose |
| Observed serum concentration at the end of a dosing interval(Ctau) | Cycle 1(each cycle is 21 days) Day 1 up to 60 days after last dose |
| Area under the concentration-time curve in 1 dosing interval(AUC(TAU)) | Cycle 1(each cycle is 21 days) Day 1 up to 60 days after last dose |
Countries
Japan
Outcome results
None listed