ECOG-ACRIN EA5162
Trial Overview
Official Title
Phase II Study of Osimertinib in Advanced NSCLC Patients with Exon 20 Mutations in EGFR
Study Purpose
To evaluate the best objective response rate of AZD9291 (osimertinib) among patients with EGFR exon 20 insertions.
Diagnosis
Stage IIIB or IV advanced non-small cell lung cancer with EGFR exon 20 insertion mutation.Eligibility
ECOG performance status 0 or 1.
Documentation of EGFR exon 20 insertion mutation.
Must have had at least one prior treatment for advanced and/or metastatic lung cancer-may have received more than 1 treatment.
Must have disease that is measurable by CT scan.
No prior treatment with therapies targeting PDL-1 or PD1 or CTLA4.
Normal organ and bone marrow function.
Patients must sign an approved informed consent and authorization permitting release of personal health information.
Intervention
- Osimertinib 160 mg orally every day.
- Cycle 21 days
- CT scans for response every 6 weeks.
For more information, visit ClinicalTrials.gov
Key Participation Requirements
Trial Location(s)
Gender
Male or Female
Age
19 years and older
Enrollment Status
Recruiting
Phase
Phase II
Methodist Health System Trial Code
EA5162