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

NCT ID: NCT01130753

Last Updated: 2013-05-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 43 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-01-31
• Study Completion Date: 2012-12-31

Brief Summary

This study propose neoadjuvant chemotherapeutic role by erlotinib.

Detailed 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.

Conditions

Lung Neoplasms; Erlotinib; Neoadjuvant Therapy

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Erlotinib

Erlotinib 150mg per day for 8 weeks

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Samsung Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Keunchil Park

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Samsung Medical Center

Seoul, , South Korea

Countries

South Korea

Other Identifiers

2006-08-029

Identifier Type: -

Identifier Source: org_study_id