NL-OMON29708
Completed
Phase 2
A phase II study to investigate the efficacy of neoadjuvant erlotinib in patients with clinical stage I/II non-small cell lung cancer (NSCLC) - NEL (Neoadjuvant Erlotinib in Lung cancer)
Antoni van Leeuwenhoek Ziekenhuis0 sites55 target enrollmentTBD
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- early stage lung cancer
- Sponsor
- Antoni van Leeuwenhoek Ziekenhuis
- Enrollment
- 55
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Patients who are candidates for lung resection for pathologically proven NSCLC or high (\> 95%) probability of NSCLC based on medical history, chest X\-ray, spiral CT\-scan, bronchoscopy and \[18F]\-FDG\-PET\-scan
- •2\. Clinical T1\-3N1\-0 stage (no mediastinal uptake on \[18F]\-FDG\-PET imaging, negative endoscopic ultrasound guided fine needle aspiration cytology (EUS\-FNA) or mediastinoscopy)
- •3\. Primary lesion diameter considered measurable, the longest diameter being \>\=1 cm measured by spiral CT scan
- •4\. For the first 15 eligible patients, two out of four of the following criteria apply:
- •a. Never smoker of ex\-smoker (less than 10 pack years)
- •b. Female gender
- •c. Non\-squamous histology
- •d. Asian origin
- •5\. WHO performance status of 0/1
- •6\. 18 years of age or older
Exclusion Criteria
- •1\. Any unstable systemic disease (including active infection, grade 4 hypertension, unstable angina, congestive heart failure)
- •2\. Current smoking
- •3\. Prior therapy with systemic anti\-tumor therapy with HER1/EGFR inhibitors (as small molecule or monoclonal antibody therapy)
- •4\. Any significant ophthalmologic abnormality, especially severe dry eye syndrome, keratoconjunctivitis sicca, Sjögren syndrome, severe exposure keratitis or any other disorder likely to increase the risk of corneal epithelial lesions
- •5\. The use of contact lenses
- •6\. Patients who cannot take oral medication, have had prior surgical procedures affecting absorption, or have active peptic ulcer disease
- •7\. Nursing mothers
Outcomes
Primary Outcomes
Not specified
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