Small Cell Lung Cancer
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria: Symptomatic central nervous system (CNS) metastases Greater than or equal to 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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety and Tolerability Number of participants with adverse events (AEs) Number of participants with serious adverse events (SAEs ) Number of Discontinuations due to AEs Number of Deaths due to AEs Number of participants with laboratory toxicity grade shift from baseline | — |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacokinetics (PK) Immunogenicity Efficacy Following PK Parameters: Cmax, Tmax, AUC(0-T), Ctau, AUC(TAU) Anti-drug antibodies (ADA) Best overall response (BOR) and duration of response (DOR) | — |