non-small cell lung cancer
Conditions
Brief summary
OS, PFS using Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1) as assessed by BICR
Detailed description
Confirmed ORR using RECIST v1.1 as assessed by BICR, PFS using RECIST v1.1 as assessed by investigator, Confirmed ORR using RECIST v1.1 as assessed by investigator, Duration of response (DOR) using RECIST v1.1 as assessed by BICR, DOR using RECIST v1.1 as assessed by investigator, Type, incidence, severity, seriousness, and relatedness of adverse events (AEs), Plasma concentration at end of infusion (CEOI) and Plasma predose concentration (Cpredose) for antibody conjugated monomethyl auristatin E (ac-MMAE) and unconjugated monomethyl auristatin E (MMAE), Incidence of antidrug antibodies (ADAs)
Interventions
Sponsors
Eligibility
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| OS, PFS using Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1) as assessed by BICR | — |
Secondary
| Measure | Time frame |
|---|---|
| Confirmed ORR using RECIST v1.1 as assessed by BICR, PFS using RECIST v1.1 as assessed by investigator, Confirmed ORR using RECIST v1.1 as assessed by investigator, Duration of response (DOR) using RECIST v1.1 as assessed by BICR, DOR using RECIST v1.1 as assessed by investigator, Type, incidence, severity, seriousness, and relatedness of adverse events (AEs), Plasma concentration at end of infusion (CEOI) and Plasma predose concentration (Cpredose) for antibody conjugated monomethyl auristatin E (ac-MMAE) and unconjugated monomethyl auristatin E (MMAE), Incidence of antidrug antibodies (ADAs) | — |
Countries
Austria, Belgium, Bulgaria, Czechia, Denmark, France, Germany, Greece, Hungary, Italy, Netherlands, Poland, Romania, Slovakia, Spain