Advanced Non-small Cell Lung Cancer
Conditions
Brief summary
Part 1 Primary - Incidence of TEAEs Treatment-related adverse events leading to discontinuation of treatment, Part 2 Primary - PFS (time from randomization to disease progression per RECIST 1.1 or death, whichever comes first)
Detailed description
Part 1 Secondary - ORR, as determined by the Investigator (per RECIST 1.1), and DOR. Part 1 Secondary - Changes in ctDNA over time. Part 1 Secondary - Cmax, Ctrough, and other key exposure parameters., Part 2 Secondary - ORR (RECIST 1.1), DCR and DOR. Part 2 Secondary - OS (time from randomization to death from any cause). Part 2 Secondary - Incidence of TEAEs. Part 2 Secondary - Changes in ctDNA over time. Part 2 Secondary - Cmax, Ctrough and other key exposure parameters.
Interventions
DRUGVudalimab
DRUGKEYTRUDA 25 mg/mL concentrate for solution for infusion
Sponsors
Xencor Inc.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Part 1 Primary - Incidence of TEAEs Treatment-related adverse events leading to discontinuation of treatment, Part 2 Primary - PFS (time from randomization to disease progression per RECIST 1.1 or death, whichever comes first) | — |
Secondary
| Measure | Time frame |
|---|---|
| Part 1 Secondary - ORR, as determined by the Investigator (per RECIST 1.1), and DOR. Part 1 Secondary - Changes in ctDNA over time. Part 1 Secondary - Cmax, Ctrough, and other key exposure parameters., Part 2 Secondary - ORR (RECIST 1.1), DCR and DOR. Part 2 Secondary - OS (time from randomization to death from any cause). Part 2 Secondary - Incidence of TEAEs. Part 2 Secondary - Changes in ctDNA over time. Part 2 Secondary - Cmax, Ctrough and other key exposure parameters. | — |
Countries
Belgium, Greece, Netherlands, Poland, Portugal, Romania, Spain
Outcome results
None listed