NCT03433469

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

A Phase II Study to Evaluate Neoadjuvant Osimertinib Therapy in Patients With Surgically Resectable, EGFR-Mutant Non-Small Cell Lung Cancer

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 27 (actual)
• Sponsor: University of California, San Francisco · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

PRIMARY OBJECTIVES: I. To evaluate the efficacy of osimertinib as neoadjuvant therapy in patients with surgically resectable EGFR-mutant non-small cell lung cancer (NSCLC). SECONDARY OBJECTIVES: I. To evaluate the safety of osimertinib given as neoadjuvant therapy in early stage EGFR-mutant NSCLC participants. II. To evaluate whether neoadjuvant osimertinib treatment increases the frequency of tumors that are unresectable due to adverse events or disease progression. III. To evaluate secondary measures of clinical efficacy in early stage EGFR-mutant NSCLC patients treated with osimertinib induction therapy. TERTIARY OBJECTIVES: I. To evaluate long-term measures of efficacy in patients treated with osimertinib neoadjuvant therapy. II. To explore tissue and cell-free biomarkers that may be predictive of response or primary resistance to osimertinib neoadjuvant therapy. OUTLINE: Participants receive osimertinib orally (PO) once daily (QD) on days 1-28. Treatment repeats every 28 days for up to 2 cycles in the absence of disease progression or unacceptable toxicity. Patients then undergo surgical resection of their cancer. After completion of study treatment, participants are followed up at 30 days then every 3 months for up to 1 year.

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

Interventions

Type	Name	Description
DRUG	Osimertinib	Given PO (orally)
PROCEDURE	Therapeutic Conventional Surgery	Undergo surgery

Timeline

• Start date: 2018-07-31
• Primary completion: 2023-01-31
• Completion: 2027-09-30
• First posted: 2018-02-14
• Last updated: 2026-03-30
• Results posted: 2024-01-18

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study