C5751002 - A randomized, phase 3, open-label study to evaluate sigvotatug vedotin compared with docetaxel in adult participants with previously treated non-small cell lung cancer (Be6A Lung-01)

Conditions

Non-Small Cell Lung Cancer (NSCLC)

Brief summary

OS, PFS using Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1) as assessed by BICR

Detailed description

Confirmed ORR using RECIST v1.1 as assessed by BICR, Confirmed ORR using RECIST v1.1 as assessed by investigator, PFS using RECIST v1.1 as assessed by investigator, DOR using RECIST v1.1 as assessed by BICR, DOR using RECIST v1.1 as assessed by investigator, Type, incidence, severity, seriousness, and relatedness of adverse events (AEs), Mean scores and change from baseline in the global health status/QoL combined score on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30), Mean scores and change from baseline in physical functioning and role functioning scores on the EORTC QLQ-C30, Mean scores and change from baseline in the dyspnea, cough, and chest pain scores on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Lung Cancer 13 (EORTC QLQ-LC13), TTD in the global health status/QoL combined score on the EORTC QLQ-C30, TTD in physical functioning and role functioning scores on the EORTC QLQ-C30, TTD in the dyspnea, cough, and chest pain scores on the EORTC QLQ-LC13

Related papers

No related papers found yet.

Interventions

DRUGDOCETAXEL

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
OS, PFS using Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1) as assessed by BICR	—

Secondary

Measure	Time frame
Confirmed ORR using RECIST v1.1 as assessed by BICR, Confirmed ORR using RECIST v1.1 as assessed by investigator, PFS using RECIST v1.1 as assessed by investigator, DOR using RECIST v1.1 as assessed by BICR, DOR using RECIST v1.1 as assessed by investigator, Type, incidence, severity, seriousness, and relatedness of adverse events (AEs), Mean scores and change from baseline in the global health status/QoL combined score on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30), Mean scores and change from baseline in physical functioning and role functioning scores on the EORTC QLQ-C30, Mean scores and change from baseline in the dyspnea, cough, and chest pain scores on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Lung Cancer 13 (EORTC QLQ-LC13), TTD in the global health status/QoL combined score on the EORTC QLQ-C30, TTD in physical functioning and role functioning scores on t	—

Measure

Time frame

Confirmed ORR using RECIST v1.1 as assessed by BICR, Confirmed ORR using RECIST v1.1 as assessed by investigator, PFS using RECIST v1.1 as assessed by investigator, DOR using RECIST v1.1 as assessed by BICR, DOR using RECIST v1.1 as assessed by investigator, Type, incidence, severity, seriousness, and relatedness of adverse events (AEs), Mean scores and change from baseline in the global health status/QoL combined score on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30), Mean scores and change from baseline in physical functioning and role functioning scores on the EORTC QLQ-C30, Mean scores and change from baseline in the dyspnea, cough, and chest pain scores on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Lung Cancer 13 (EORTC QLQ-LC13), TTD in the global health status/QoL combined score on the EORTC QLQ-C30, TTD in physical functioning and role functioning scores on t

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Countries

Austria, Belgium, Czechia, France, Germany, Greece, Hungary, Italy, Netherlands, Norway, Poland, Romania, Spain

Outcome results

None listed