Testing Osimertinib as a Treatment for Lung Cancers With an EGFR Exon 20 Change

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

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Biospecimen Collection — PROCEDURE
  Undergo collection of blood samples
• Computed Tomography with Contrast — PROCEDURE
  Undergo CT with contrast
• Echocardiography Test — PROCEDURE
  Undergo ECHO
• Magnetic Resonance Imaging — PROCEDURE
  Undergo MRI
• Multigated Acquisition Scan — PROCEDURE
  Undergo MUGA
• Osimertinib — DRUG
  Given PO

Study Details

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.

Key Dates

Start date

Apr 25, 2018

Status verified

Apr 2026

Primary completion

Jun 30, 2027

Completion

Jun 30, 2027

Study Design

Enrollment

46 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Treatment (osimertinib)
  Patients receive osimertinib PO QD on days 1-21 of each cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients undergo ECHO or MUGA, MRI or CT with contrast, and collection of blood samples throughout the trial.

Primary Outcome Measure

Best objective response [ Time Frame: Up to 5 years ]

Locations (345)

Find similar trials in Anchorage, AK

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