Phase 23 Study of Telisotuzumab Adizutecan Compared to Standard of Care in Adults With Advanced EGFR-Mutated Non-Squamous NSCLC After Progression on Third-Generation EGFR TKI

What this Trial Is About

This research aims to evaluate the effects of telisotuzumab adizutecan, an investigational drug, compared to standard treatments in adults with locally advanced or metastatic EGFR-mutated non-squamous non-small cell lung cancer NSCLC who have progressed after third-generation EGFR TKI therapy. The study includes two stages a phase 2 dose-finding period and a phase 3 randomized comparison. Approximately 430 adults will participate across about 200 sites worldwide, with the study lasting approximately 69 months. In phase 2, participants receive one of two intravenous doses of telisotuzumab adizutecan. In phase 3, participants are randomly assigned to receive either the recommended phase 3 dose of telisotuzumab adizutecan or the investigators choice of standard of care SOC. Treatments are delivered via IV infusion throughout the study period. The trial is open-label and aims to compare safety and disease activity outcomes between the drug and SOC. Participants will attend regular visits at hospitals or clinics for medical assessments, blood tests, and questionnaires to monitor side effects and treatment effects. Researchers will measure objective response, progression-free survival, overall survival, duration of response, disease control, and quality of life, including physical functioning and lung cancer symptoms. These assessments will be conducted up to about 69 months, with some quality of life measures evaluated up to week 12.

A Study to Assess Adverse Events and Change in Disease Activity of Intravenous (IV) Telisotuzumab Adizutecan Compared to Standard of Care in Adult Participants With Locally Advanced or Metastatic EGFR-Mutated Non-Squamous Non-Small Cell Lung Cancer