Neoadjuvant Erlotinib for Operable Stage II or IIIA NSCLC With EGFR Mutations

• Status: Recruiting
• Trial end date: 2022-09-01
• Target enrollment: 0
• Participant gender: All

Summary

This study examines preoperative Erlotinib in patients with operable stage II and IIIA Non-small-cell lung cancer (NSCLC) harboring EGFR mutations.

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

Details

• Lead Sponsor: National Cancer Center, Korea
• Collaborator: Hoffmann-La Roche
• Treatments: Erlotinib Hydrochloride

Criteria

Inclusion Criteria:

• Pathologically confirmed stage II & IIIA non-small cell lung cancer

• EGFR exon 19 or 21 mutations

• 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:

• 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