Testing Osimertinib as a Treatment for Lung Cancers With an EGFR Exon 20 Change
Phase II Study of Osimertinib (AZD9291) in Advanced NSCLC Patients With Exon 20 Insertion Mutations in EGFR
Sponsor: National Cancer Institute (NCI)
A observational or N/A phase clinical study on Advanced Lung Non-Small Cell Carcinoma and Recurrent Lung Non-Small Cell Carcinoma, this trial is actively recruiting participants. The trial is conducted by National Cancer Institute (NCI) and has accumulated 85 data snapshots since 2018. Oncology trials at this stage typically focus on safety, tolerability, and early efficacy signals.
Study Description(click to expand)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 retrospective analyses of pre-treatment tumor tissue.
III. To identify resistance mechanisms to osimertinib (AZD9291) through post-progression tumor biopsies and circulating tumor (ct)DNA.
OUTLINE:
Patients receive osimertinib orally (PO) once daily (QD) on days 1-21 of each cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients undergo echocardiography (ECHO) or multigated acquisition scan (MUGA), magnetic resonance imaging (MRI) or computed tomography (CT) with contrast, and collection of blood samples throughout the trial.
After completion of study treatment, patients are followed up at 30 days and every 3 months for up to 5 years.
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 retrospective analyses of pre-treatment tumor tissue.
III. To identify resistance mechanisms to osimertinib (AZD9291) through post-progression tumor biopsies and circulating tumor (ct)DNA.
OUTLINE:
Patients receive osimertinib orally (PO) once daily (QD) on days 1-21 of each cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients undergo echocardiography (ECHO) or multigated acquisition scan (MUGA), magnetic resonance imaging (MRI) or computed tomography (CT) with contrast, and collection of blood samples throughout the trial.
After completion of study treatment, patients are followed up at 30 days and every 3 months for up to 5 years.
Status Flow
Change History
85 versions recorded-
May 4, 2026 — Present [daily]
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Apr 16, 2026 — May 4, 2026 [daily]
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First recorded
Eligibility 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.
Contact Information
- National Cancer Institute (NCI)
For direct contact, visit the study record on ClinicalTrials.gov .