Phase II Study of Sacituzumab Tirumotecan and Furmonertinib in Adults with Advanced EGFR-Mutated Non-Squamous Non-Small Cell Lung Cancer After EGFR-TKI and Chemotherapy

What this Trial Is About

This research aims to evaluate the effectiveness and safety of combining sacituzumab tirumotecan with furmonertinib in patients who have locally advanced or metastatic non-squamous non-small cell lung cancer NSCLC with specific EGFR mutations. These patients have experienced progression after treatment with EGFR-TKI therapies and platinum-based chemotherapy. The study builds on previous findings that showed promising benefits with similar drug combinations in this patient population. Participants receive sacituzumab tirumotecan at a dose of 5 mgkg through intravenous infusion on days 1 and 15 of each treatment cycle, along with daily oral doses of furmonertinib mesylate at 80 mg. The study will monitor patients over a period of up to 24 months to assess progression-free survival, overall survival, response rates, duration of response, quality of life, and safety. Throughout the study, participants will undergo regular assessments including tumor tissue or biopsy for biomarker analysis, laboratory tests to monitor organ and cardiac function, and questionnaires to evaluate quality of life. Safety and treatment responses will be closely monitored up to 24 months. The study requires patients to have adequate organ function and an ECOG performance status of 0 or 1, with expected survival beyond six months, ensuring they can comply with study procedures and visits.

A Phase II Study of Sacituzumab Tirumotecan in Combination With Furmonertinib in Patients With Non-squamous Non-Small Cell Lung Cancer Who Have Progressed After EGFR-TKI and Platinum-Based Chemotherapy