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Phase II Study of AZD9291 (Osimertinib) in Advanced NSCLC Patients with Exon 20 Insertion Mutations in EGFR

Temporarily Closed
Cancer Type
Lung Cancer
Trial Phase
Phase II
18 Years and older, Male and Female
Study Type
Protocol IDs
EA5162 (primary)
Study Sponsor
ECOG-ACRIN Cancer Research Group


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.


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. Courses 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.

Treatment Sites in Georgia

Emory Saint Joseph's Hospital

5665 Peachtree Dunwoody Road NE
Atlanta, GA 30342

Emory University Hospital - Midtown

550 Peachtree Street NE
Atlanta, GA 30308

Winship Cancer Institute of Emory University

1365 Clifton Road NE
Building C
Atlanta, GA 30322

**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.
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