Non-Small Cell Lung Cancer (NSCLC)
Conditions
Brief summary
Progression-Free Survival as assessed by BICR in non-squamous TROP2 biomarker positive analysis set, defined as time from randomisation until progression per RECIST 1.1 or death due to any cause., Overall Survival in non-squamous TROP2 biomarker positive analysis set, defined as the time from randomisation until the date of death due to any cause, Progression-Free Survival as assessed by BICR in non-squamous full analysis set, defined as time from randomisation until progression per RECIST 1.1 or death due to any cause., Overall Survival in non-squamous full analysis set, defined as the time from randomisation until the date of death due to any cause
Detailed description
Progression-Free Survival as assessed by BICR, Overall Survival, Objective Response Rate as determined by BICR, Duration of Response as assessed by BICR and investigator assessment, Progression-Free Survival as assessed by investigator assessment, and Time to second progression or death in ITT and TROP2 biomarker-defined populations, Objective Response Rate as determined by BICR, Duration of Response as assessed by BICR and investigator assessment, Progression-Free Survival as assessed by investigator assessment, and Progression-Free Survival 2 in the non-squamous population, Clinical Outcome Assessments as measured by the NSCLC-SAQ and PROMIS Physical Function short form 8c., Pharmacokinetics and immunogenicity
Interventions
Sponsors
Eligibility
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-Free Survival as assessed by BICR in non-squamous TROP2 biomarker positive analysis set, defined as time from randomisation until progression per RECIST 1.1 or death due to any cause., Overall Survival in non-squamous TROP2 biomarker positive analysis set, defined as the time from randomisation until the date of death due to any cause, Progression-Free Survival as assessed by BICR in non-squamous full analysis set, defined as time from randomisation until progression per RECIST 1.1 or death due to any cause., Overall Survival in non-squamous full analysis set, defined as the time from randomisation until the date of death due to any cause | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-Free Survival as assessed by BICR, Overall Survival, Objective Response Rate as determined by BICR, Duration of Response as assessed by BICR and investigator assessment, Progression-Free Survival as assessed by investigator assessment, and Time to second progression or death in ITT and TROP2 biomarker-defined populations, Objective Response Rate as determined by BICR, Duration of Response as assessed by BICR and investigator assessment, Progression-Free Survival as assessed by investigator assessment, and Progression-Free Survival 2 in the non-squamous population, Clinical Outcome Assessments as measured by the NSCLC-SAQ and PROMIS Physical Function short form 8c., Pharmacokinetics and immunogenicity | — |
Countries
Austria, Bulgaria, France, Germany, Greece, Hungary, Italy, Poland, Spain, Sweden