NCT01130753

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

A Phase II Trial of Neoadjuvant Erlotinib (Tarceva®) Followed by Surgery for Selected Patients With Stage IIIA, N2-positive Non-Small Cell Lung Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 43 (estimated)
• Sponsor: Samsung Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	Erlotinib	Erlotinib 150mg per day for 8 weeks

Timeline

• Start date: 2007-01-01
• Primary completion: 2010-12-01
• Completion: 2012-12-01
• First posted: 2010-05-26
• Last updated: 2013-05-30

Locations

1 site across 1 country: South Korea