Last updated on June 2019

Osimertinib in Treating Patients With Stage IIIB-IV or Recurrent Non-small Cell Lung Cancer With EGFR Exon 20 Insertion Mutations

Brief description of study

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. Osimertinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Detailed Study Description


I. To evaluate the best objective response rate of AZD9291 (osimertinib) among patients with EGFR exon 20 insertions.


I. To determine the safety profile of 160 mg once daily (QD) dose of AZD9291 (osimertinib) in patients with EGFR Exon 20 insertion mutations.

II. To determine the progression-free survival. III. To determine the overall survival.


I. To characterize molecular markers of response to treatment in circulating tumor deoxyribonucleic acid (DNA).

II. To evaluate biomarkers of response to treatment through retrospective analyses of pre-treatment tumor tissue.

III. To identify resistance mechanisms to AZD9291 (osimertinib) through post-progression tumor biopsies and circulating tumor (ct)DNA.


Patients receive osimertinib orally (PO) once daily (QD) on days 1-21. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up at 28 days and every 3 months for up to 5 years.

Clinical Study Identifier: NCT03191149

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Fox Chase Cancer Center

Philadelphia, PA United States
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Temple University Hospital

Philadelphia, PA United States
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Recruitment Status: Open

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