Efficacy of Erlotinib in Neoadjuvant Setting in Patients With Stage IIIA, N2-positive Non-Small Cell Lung Cancer

• Status: Completed
• Trial end date: 2012-12-01
• Target enrollment: 0
• Participant gender: All

Summary

This study propose neoadjuvant chemotherapeutic role by erlotinib.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Samsung Medical Center
• Treatments: Erlotinib Hydrochloride

Criteria

Inclusion Criteria:

• Pathologically confirmed N2 positive and stage IIIA non-small cell lung cancer

• Has more than 2 conditions out of following 3 conditions ; adenocarcinoma, non-smoker, women

• Age ≥ 18 years and ECOG performance 0~1

• Has measurable lesion by RECIST 1.1

• No previous chemotherapy or radiation therapy

• Adequate organ function by following; ANC ≥1,500/uL, hemoglobin ≥9.0g/dL, platelet ≥100,000/uL, PaO2 ≥ 60 mmHg, Serum Cr < 1 x UNL or creatinine clearance > 60 ml/min, Serum bilirubin < 1 x UNL, AST (SGOT) and ALT (SGPT) < 2.5 x UNL, alkaline phosphatase < 5 x UNL

• Written informed consent form

Exclusion Criteria:

• Pulmonary carcinoid tumor

• Previous chemotherapy or radiation therapy

• Previous history of malignancy within 5 years from study entry except treated non-melanomatous skin cancer or uterine cervical cancer in situ

• Known allergic history of erlotinib

• Interstitial lung disease or fibrosis on chest radiogram

• Active infection, uncontrolled systemic disease (cardiopulmonary insufficiency, fatal arrhythmias, hepatitis)

• Pregnant or nursing women