Phase 2 Study of Osimertinib as Pre-Surgery Treatment for Resectable Stage II-IIIB EGFR-Mutated Lung Squamous Cell Carcinoma

What this Trial Is About

Researchers are studying the safety and feasibility of neoadjuvant osimertinib treatment in patients with resectable stage II-IIIB lung squamous cell carcinoma who have EGFR mutations. This research addresses a gap as previous trials focused less on this rare lung cancer subtype. The study is a phase 2 trial conducted by The First Affiliated Hospital of Guangzhou Medical University, aiming to understand how well this targeted therapy works before surgery. Patients enrolled in this trial will receive osimertinib orally at a dose of 80 mg daily for at least 9 weeks before surgery. This neoadjuvant treatment aims to reduce tumor size and improve surgical outcomes. The trial is a single-arm study, meaning all participants receive the same treatment without comparison groups. During the study, participants will be monitored for tumor response and safety. Key measures include the objective response rate four weeks after treatment, severe adverse events up to 30 days after drug administration or surgery, and major pathologic response after surgery. Participants will also be followed for progression-free survival, overall survival, disease control, and remission duration for up to five years. The study will involve imaging, lab tests, and clinical evaluations throughout the treatment and follow-up periods.

Neoadjuvant Targeted Therapy in Patients With Resectable EGFR-mutated Lung Squamous Cell Carcinoma