early stage lung cancer non-small cell lung cancer stage I/II
Conditions
Interventions
erlotinib 150mg/day, oral dose, 1 hour before or 2 hours after a meal,
given once daily for 3 weeks, preoperative.
Sponsors
Antoni van Leeuwenhoek Ziekenhuis
Eligibility
Age
18 Years to 99 Years
Inclusion 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 7. Able to comply with study and follow-up procedures 8. For all females of childbearing potential a negative pregnancy test must be obtained within 72 hours before starting therapy 9. Patients with reproductive potential must use effective contraception 10. Informed consent to participate in the study
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Pathologic tumor response after 3 weeks of erlotinib | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Radiological (CT) and metabolic (FDG-PET) response after 3 weeks of treatment with erlotinib 2. Description of factors predictive for response: - early metabolic response (FDG-PET after 3 days of treatment) - molecular tumor characteristics, as EGFR mutations (HER1) 3. Toxicity of neoadjuvant treatment with erlotinib in combination with surgical treatment 4.Overall survival, disease-free survival and locoregional control | — |
Countries
Netherlands
Outcome results
None listed