Extensive Stage Small Cell Lung Cancer (ES-SCLC)
Conditions
Brief summary
ORR is defined as the percentage of participants who have achieved a complete response (CR) or partial response (PR) as assessed by BICR according to RECIST v1.1, OS is defined as length of time from randomization until the date of death from any cause
Detailed description
PFS is defined as the time from date of randomization until disease progression as assessed by BICR according to RECIST v1.1 or death from any cause, whichever comes first, DOR is defined as is measured from the time of first response (CR or PR) as assessed by BICR according to RECIST v1.1, until the date of first documented disease progression or death, whichever comes first, Time to first deterioration in shortness of breath, Time to first deterioration in physical functioning, Incidence of treatment-emergent adverse events (AEs) and clinical laboratory abnormalities
Interventions
DRUGTrodelvy 200 mg powder for concentrate for solution for infusion
Sponsors
Gilead Sciences Inc.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ORR is defined as the percentage of participants who have achieved a complete response (CR) or partial response (PR) as assessed by BICR according to RECIST v1.1, OS is defined as length of time from randomization until the date of death from any cause | — |
Secondary
| Measure | Time frame |
|---|---|
| PFS is defined as the time from date of randomization until disease progression as assessed by BICR according to RECIST v1.1 or death from any cause, whichever comes first, DOR is defined as is measured from the time of first response (CR or PR) as assessed by BICR according to RECIST v1.1, until the date of first documented disease progression or death, whichever comes first, Time to first deterioration in shortness of breath, Time to first deterioration in physical functioning, Incidence of treatment-emergent adverse events (AEs) and clinical laboratory abnormalities | — |
Countries
Belgium, France, Germany, Greece, Hungary, Italy, Netherlands, Norway, Poland, Romania, Spain
Outcome results
None listed