Non-small cell lung cancer (NSCLC)
Conditions
Brief summary
ORR is the proportion of subjects with confirmed complete response (CR) or confirmed partial response (PR) per blinded independent central review (BICR).
Detailed description
PFS is the time from randomization until the first documentation of disease progression per BICR or death due to any cause, whichever occurs first., ORR is the proportion of subjects with confirmed CR or confirmed PR per BICR., OS is the time from randomization until death due to any cause., Safety including but not limited to: TEAEs, SAEs, deaths, and clinical laboratory abnormalities per NCI CTCAE v5.0 except for CRS, which will be graded according to the ASTCT guidelines., Incidence of STK-012 antibodies and qualitative assessment of safety outcomes., PK characterization of STK-012 (eg, AUC, Cmax, Tmax, t1/2).
Interventions
DRUGSTK-012
DRUGPemetrexed Glenmark 10 mg/ml Infusionslösung
Sponsors
Synthekine Inc.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ORR is the proportion of subjects with confirmed complete response (CR) or confirmed partial response (PR) per blinded independent central review (BICR). | — |
Secondary
| Measure | Time frame |
|---|---|
| PFS is the time from randomization until the first documentation of disease progression per BICR or death due to any cause, whichever occurs first., ORR is the proportion of subjects with confirmed CR or confirmed PR per BICR., OS is the time from randomization until death due to any cause., Safety including but not limited to: TEAEs, SAEs, deaths, and clinical laboratory abnormalities per NCI CTCAE v5.0 except for CRS, which will be graded according to the ASTCT guidelines., Incidence of STK-012 antibodies and qualitative assessment of safety outcomes., PK characterization of STK-012 (eg, AUC, Cmax, Tmax, t1/2). | — |
Countries
Ireland, Italy, Poland, Spain
Outcome results
None listed