Phase II Study of Oral Osimertinib for Advanced or Recurrent Non-Small Cell Lung Cancer with EGFR Exon 20 Insertion Mutation

What this Trial Is About

Researchers are evaluating how well osimertinib works in treating patients with advanced non-small cell lung cancer NSCLC that has a specific EGFR exon 20 insertion mutation. This includes patients with stage IIIB-IV disease or those whose cancer has returned after improvement. The study is a phase II trial aiming to understand the tumor response and safety profile of osimertinib in this group. Researchers also want to explore molecular and genetic markers related to treatment response and resistance. Participants receive osimertinib orally once daily in 21-day cycles, continuing until the cancer worsens or side effects become unacceptable. During treatment, patients have imaging tests like echocardiography or MUGA scans, MRI or CT scans with contrast, and blood samples collected to monitor their health and disease. After stopping treatment, patients are followed for 30 days and then every three months for up to five years to assess long-term outcomes. Throughout the study, researchers measure the best tumor response, progression-free survival, overall survival, and any side effects experienced. They also analyze blood and tumor samples to study molecular markers and resistance mechanisms. The total participation can last up to five years, including treatment and follow-up periods, with regular imaging and laboratory assessments to track the disease and patient safety.

Testing Osimertinib as a Treatment for Lung Cancers With an EGFR Exon 20 Change