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

Phase 2

Completed

• Conditions: Lung Neoplasms; Erlotinib; Neoadjuvant Therapy

• Registration Number: NCT01130753
• Lead Sponsor: Samsung Medical Center

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.

Study Timeline

• Study Start: 2007-01
• Study First Submitted: 2010-05-17
• Study First Submitted QC: 2010-05-25
• Study First Posted: 2010-05-26
• Primary Completion: 2010-12
• Study Completion: 2012-12
• Status Verified: 2013-05
• Last Update Submitted: 2013-05-29
• Last Update Posted: 2013-05-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 43

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Pathologic down-staging	36 months

Secondary Outcome Measures

Name	Time	Method
Response rate	36 months
Toxicity	36 months
Progression free survival	36 months
Overall survival	36 months

Trial Locations

Locations (1)

Samsung Medical Center; 🇰🇷 Seoul, Korea, Republic of