Advanced Non-Small Cell Lung Cancer
Conditions
Brief summary
Objective response rate (ORR) as assessed by blinded independent review committee (BIRC) using Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1)
Detailed description
ORR by investigator assessment, Duration of Response (DOR) as assessed by BIRC using RECIST 1.1, DOR by investigator assessment, Progression Free Survival (PFS) as assessed by BIRC using RECIST 1.1, PFS by investigator assessment, Overall Survival (OS), Incidence of treatment-emergent adverse events (TEAEs), Incidences of serious adverse events (SAEs), Incidences of deaths, Incidences of laboratory abnormalities
Interventions
DRUGBNT116
DRUGLIBTAYO 350 mg concentrate for solution for infusion.
Sponsors
Regeneron Pharmaceuticals Inc.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate (ORR) as assessed by blinded independent review committee (BIRC) using Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) | — |
Secondary
| Measure | Time frame |
|---|---|
| ORR by investigator assessment, Duration of Response (DOR) as assessed by BIRC using RECIST 1.1, DOR by investigator assessment, Progression Free Survival (PFS) as assessed by BIRC using RECIST 1.1, PFS by investigator assessment, Overall Survival (OS), Incidence of treatment-emergent adverse events (TEAEs), Incidences of serious adverse events (SAEs), Incidences of deaths, Incidences of laboratory abnormalities | — |
Countries
Germany, Poland, Spain
Outcome results
None listed