Phase 23 Study of Telisotuzumab Adizutecan with Osimertinib as First Treatment for Adults with Advanced EGFR-Mutated Non-Squamous Non-Small Cell Lung Cancer

What this Trial Is About

Researchers are studying non-squamous non-small cell lung cancer NSCLC with specific mutations in the EGFR gene that cause abnormal cell growth in the lungs. This study aims to evaluate side effects and changes in disease activity when the investigational drug telisotuzumab adizutecan is combined with the approved drug osimertinib Osi, compared to standard care that includes Osi with chemotherapy. The study is conducted in two stages and includes adults with locally advanced or metastatic NSCLC. In the first stage, participants receive increasing intravenous doses of telisotuzumab adizutecan along with oral osimertinib. Then, participants are randomly assigned to one of several groups receiving different doses of telisotuzumab adizutecan plus Osi or the standard of care involving Osi plus chemotherapy. In the second stage, participants receive the optimal dose of telisotuzumab adizutecan with Osi or standard care. The study treatments will be given over approximately 76 months at medical centers worldwide. Participants will attend regular visits where doctors will monitor treatment effects through medical exams, blood tests, questionnaires, and side effect evaluations. Researchers will measure tumor response, progression-free survival, and adverse events over the study period. Quality of life and lung cancer symptoms will also be assessed using questionnaires. Safety and disease activity will be closely followed throughout the long duration of the trial.

A Study to Assess Adverse Events, Change in Disease Activity of Intravenous Telisotuzumab Adizutecan in Combination With Osimertinib as First-Line Treatment in Adult Participants With Locally Advanced Unresectable or Metastatic EGFR-Mutated Non-Squamous Non-Small Cell Lung Cancer