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

Samsung Medical Center

Status and phase: Completed; Phase 2

Conditions: Lung Neoplasms; Neoadjuvant Therapy; Erlotinib

Treatments: Drug: Erlotinib

Study type: Interventional

Funder types: Other

Identifiers

NCT01130753

2006-08-029

Details and patient eligibility

About

This study propose neoadjuvant chemotherapeutic role by erlotinib.

Full description

It is widely accepted that patients with locally advanced non-small cell lung cancer would have better outcome with neoadjuvant therapy followed by surgery than surgery alone. However what should be the standard treatment option is still unclear.

Erlotinib (Tarceva®)is an oral inhibitor of epidermal growth factor receptor (EGFR) tyrosine kinase and its anti-neoplastic effect is approved especially women, patients with adenocarcinoma, non-smoker and Asian population. Moreover if the malignant tissue has EGFR mutation, its efficacy is known to be enhanced.

So we expect that in those population, patients with locally advanced, N2 positive, erlotinib would be more beneficial than conventional cytotoxic chemotherapy in safety and convenience as neoadjuvant therapy.

Enrollment: 43 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)