Phase II Study of Osimertinib (AZD9291) in Advanced NSCLC Patients With Exon 20 Insertion Mutations in EGFR
National Cancer Institute (NCI)
Summary
This phase II trial studies how well osimertinib works in treating patients with non-small cell lung cancer with EGFR exon 20 insertion mutation that is stage IIIB-IV or has come back after a period of improvement (recurrent). Osimertinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
Description
PRIMARY OBJECTIVE: I. To evaluate the best objective response rate of osimertinib (AZD9291) among patients with EGFR exon 20 insertions. SECONDARY OBJECTIVES: I. To determine the safety profile of 160 mg once daily (QD) dose of osimertinib (AZD9291) in patients with EGFR Exon 20 insertion mutations. II. To determine the progression-free survival. III. To determine the overall survival. TERTIARY OBJECTIVES: I. To characterize molecular markers of response to treatment in circulating tumor deoxyribonucleic acid (DNA). II. To evaluate biomarkers of response to treatment through retrospecti…