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- Telimet-01: M18-868
Lung cancer
Telimet-01: M18-868
A Phase 3 Open-Label, Randomized, Controlled, Global Study of Telisotuzumab Vedotin;(ABBV-399) Versus Docetaxel in Subjects with Previously Treated c-Met Overexpressing, EGFR Wildtype,;Locally Advanced/Metastatic Non-Squamous Non-Small Cell Lung Cancer.
- Open at Paris since : 05/06/2024
- Target : Adult
- Phase : Phase III
Trial description
The primary objective is to determine if telisotuzumab vedotin;improves progression-free survival (PFS) per ICR assessment and/or;Overall Survival (OS) compared to docetaxel in the following nested;populations:;À Subjects with c-Met high overexpressing, EGFR wildtype, nonsquamous;NSCLC;and;À All subjects with c-Met overexpressing, EGFR wildtype, nonsquamous;NSCLC;The secondary objectives are to determine:;À Overall response rate (ORR);;À Time to deterioration in cough, pain or dyspnea as measured by;the cough, pain and dyspnea items of the European Organization;for Research and Treatment of Cancer Quality of Life;Questionnaire Lung Cancer Module 13 (EORTC QLQ-LC13);;À Time to deterioration of physical functioning as measured by the;physical functioning domain of the EORTC QLQ-Core 30 (EORTC;QLQ-C30);;À Change from baseline in quality of life as measured by the global;health status/quality of life domain of the EORTC QLQ-C30;;À Duration of response (DoR);;À Progression-free survival (PFS) per investigator assessment;;À Change from baseline in quality of life as measured by the global;health status/quality of life domain of the EORTC QLQ-C30;;À Safety and tolerability.
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