Metastatic Non–Small Cell Lung Cancer
Conditions
Brief summary
OS is defined as the time from the date of randomization to the date of death from any cause (both in participants with positive PD-L1 expression [≥ 1% TC] and in all randomized participants as dual primary endpoints)
Detailed description
PFS is defined as the time from the date of randomization until progressive disease (PD) as assessed by BICR according to RECIST v1.1 or death from any cause, whichever comes first. , ORR is defined as the proportion of participants who have achieved a complete response (CR) or partial response (PR) that is confirmed at least 4 weeks later as assessed by BICR according to RECIST v1.1, DOR is defined as the time from the first response (CR or PR), to the first documented PD, as assessed by BICR according to RECIST v1.1, or death from any cause, whichever comes first., Incidence, severity, seriousness, and relatedness of treatment-emergent adverse events (TEAEs) and incidence and severity of clinical laboratory abnormalities, Time to first symptom deterioration in NSCLC SAQ shortness of breath domain, Time to first deterioration in NSCLC-SAQ total score
Interventions
Sponsors
Eligibility
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| OS is defined as the time from the date of randomization to the date of death from any cause (both in participants with positive PD-L1 expression [≥ 1% TC] and in all randomized participants as dual primary endpoints) | — |
Secondary
| Measure | Time frame |
|---|---|
| PFS is defined as the time from the date of randomization until progressive disease (PD) as assessed by BICR according to RECIST v1.1 or death from any cause, whichever comes first. , ORR is defined as the proportion of participants who have achieved a complete response (CR) or partial response (PR) that is confirmed at least 4 weeks later as assessed by BICR according to RECIST v1.1, DOR is defined as the time from the first response (CR or PR), to the first documented PD, as assessed by BICR according to RECIST v1.1, or death from any cause, whichever comes first., Incidence, severity, seriousness, and relatedness of treatment-emergent adverse events (TEAEs) and incidence and severity of clinical laboratory abnormalities, Time to first symptom deterioration in NSCLC SAQ shortness of breath domain, Time to first deterioration in NSCLC-SAQ total score | — |
Countries
Austria, Belgium, France, Germany, Italy, Netherlands, Portugal, Spain