Osimertinib in Treating Participants With Stage I-IIIA EGFR-mutant Non-small Cell Lung Cancer Before Surgery

Conditions

• Stage I Non-Small Cell Lung Cancer
• Stage IA Non-Small Cell Lung Cancer
• Stage IB Non-Small Cell Lung Cancer
• Stage II Non-Small Cell Lung Cancer
• Stage IIA Non-Small Cell Lung Cancer
• Stage IIB Non-Small Cell Lung Cancer
• Stage IIIA Non-Small Cell Lung Cancer

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Osimertinib — DRUG
  Given PO (orally)
• Therapeutic Conventional Surgery — PROCEDURE
  Undergo surgery

Study Details

This phase II trial studies how well osimertinib works in treating participants with stage I-IIIA Epithelial Growth Factor Receptor (EGFR) -mutant non-small cell lung cancer before surgery. Osimertinib may stop the growth of tumor cells by blocking mutant EGFR signaling in cancer cells.

Key Dates

Start date

Jul 31, 2018

Status verified

Mar 2026

Primary completion

Jan 31, 2023

Completion

Sep 30, 2027

Study Design

Enrollment

27 participants (actual)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Treatment (osimertinib)
  Participants receive 80mg osimertinib orally, once a day (PO QD) on days 1-28. Treatment repeats every 28 days for a minimum of 1 cycle prior to surgery in the absence of disease progression or unacceptable toxicity. Investigators will have the option to give a second cycle of study drug prior to surgery if clinically indicated. Depending on the timing of the final scans, patients may ultimately receive up to two weeks additional therapy with study drug beyond end of cycle 1 (or cycle 2) while awaiting surgery. Patients then undergo surgical resection of their cancer. No treatment with the study drug will be given after surgery.

Primary Outcome Measure

Percentage of Participants With a Major Pathological Response (MPR) [ Time Frame: Up to 1 year ]

Locations (3)

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