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Advanced Lung Non-Small Cell CarcinomaGeneticsCancerProcedureDrugPhase 2

What this study is

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.

What's being tested

  • Biospecimen Collection

    Intervention · PROCEDURE

    Undergo collection of blood samples

  • Computed Tomography with Contrast

    Intervention · PROCEDURE

    Undergo CT with contrast

  • Echocardiography Test

    Intervention · PROCEDURE

    Undergo ECHO

  • Magnetic Resonance Imaging

    Intervention · PROCEDURE

    Undergo MRI

  • Multigated Acquisition Scan

    Intervention · PROCEDURE

    Undergo MUGA

  • Osimertinib

    Intervention · DRUG

    Given PO

Study details

Official title
Phase II Study of Osimertinib (AZD9291) in Advanced NSCLC Patients With Exon 20 Insertion Mutations in EGFR
Sponsor
National Cancer Institute (NCI)
Conditions
Advanced Lung Non-Small Cell Carcinoma · Recurrent Lung Non-Small Cell Carcinoma · Stage IIIB Lung Non-Small Cell Cancer AJCC v7 · Stage IV Lung Non-Small Cell Cancer AJCC v7
Enrolling
46 people
Starts
2018-04-25
Est. completion
2027-06-30
Design
Open-label, single group, Phase 2
Record
View on ClinicalTrials.gov ↗