A phase II study to investigate the efficacy of neoadjuvant erlotinib in patients with clinical stage I/II non-small cell lung cancer (NSCLC)

Phase 2

Completed

• Conditions: early stage lung cancer; non-small cell lung cancer stage I/II; 10038666

• Registration Number: NL-OMON29708
• Lead Sponsor: Antoni van Leeuwenhoek Ziekenhuis

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2024-08-12

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 55

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified