NCT00616499UnknownPhase 2
A Phase II Trial of Neoadjuvant Gefitinib Therapy Based on Mutation Study in Biopsy- Proven Stage IIIA N2 Non-Squamous Non-Small Cell Lung Cancer
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Sponsor
- Yonsei University
- Enrollment
- 35
- Locations
- 8
- Primary Endpoint
- Response rate
Study Overview
Brief Summary
RATIONALE: Gefitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving Gefitinib before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.
PURPOSE: This phase II trial is studying how well gefitinib works in treating patients with stage IIIA non-small cell lung cancer.
Detailed Description
OBJECTIVES:
Primary
- To assess the response rate to gefitinib treatment as preoperative induction therapy in patients with biopsy-proven stage IIIA (pN2) non-squamous non-small cell lung cancer accompanied by epidermal growth factor receptor (EGFR) mutations.
Secondary
- To determine the complete resection rate in patients treated with this drug.
- To determine the overall survival rate in patients treated with this drug.
- To determine the disease-free survival rate in patients treated with this drug.
- To determine the pathologic complete response rate in patients treated with this drug.
- To determine the toxicity of this drug in these patients.
Study Design
- Study Type
- Interventional
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Response rate
Secondary Outcomes
- Complete resection rate
- Overall survival rate
- Median disease-free survival
- Complete pathological response rate
- Toxicity
Investigators
Study Sites (8)
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