Induction Erlotinib Therapy in Stage III A (N2) Non-Small Cell Lung Cancer (NSCLC)

Phase 2

Completed

• Conditions: Carcinoma, Non-Small-Cell Lung
• Interventions: Drug: neoadjuvant gemcitabine/carboplatin therapy; Drug: neoadjuvant erlotinib therapy

• Registration Number: NCT00600587
• Lead Sponsor: Guangdong Provincial People's Hospital

Brief Summary

The purpose of this study is to evaluate the value of induction Erlotinib therapy before thoracotomy or radiotherapy in ⅢA-N2 (confirmed by mediastinoscopy or PET) non-small cell lung cancer (NSCLC) selected by epidermal growth factor receptor (EGFR) gene analysis and initial to explore a new treatment strategy for ⅢA-N2 NSCLC.

Detailed Description

Stage IIIA non-small-cell lung cancer (NSCLC) is seen in a relatively heterogeneous group of patients with ipsilateral mediastinal (N2) lymph node involvement. The relative roles of different treatment modalities are not clear. Epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors (TKIs) may result in dramatic responses in patients with pulmonary adenocarcinoma carrying EGFR activating mutations. In case reports, the efficacy of perioperative EGFR-TKI therapy in patients with locally advanced NSCLC harboring EGFR gene mutations was satisfactory. Although no prospective data support the use of EGFR-TKIs as induction therapy in stage IIIA-N2 NSCLC, their low toxicity profile and the possibility of a rapid tumor response suggests that prospective trials are required. Therefore, this study evaluated the value of induction erlotinib therapy in IIIA-N2 NSCLC selected by EGFR gene analysis and explored a new treatment strategy for this subset. Erlotinib specifically targets the EGFR TK domain, which is highly expressed and occasionally mutated in various forms of cancer. It binds in a reversible fashion to the adenosine triphosphate (ATP) binding site of the receptor.

Study Timeline

• Study Start: 2007-09
• Study First Submitted: 2008-01-14
• Study First Submitted QC: 2008-01-14
• Study First Posted: 2008-01-25
• Status Verified: 2013-06
• Primary Completion: 2013-06
• Study Completion: 2013-06
• Last Update Submitted: 2013-06-23
• Last Update Posted: 2013-06-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

• Written informed consent
• Histological or cytological documented
• Resectable NSCLC of stage IIIA-N2 confirmed by mediastinoscopy or PET
• Naive therapy NSCLC
• Candidates should be tolerated with induction therapy and thoracotomy with ECOG performance status 0-2, adequate haematological and Hepatic- renal function and qualified lung function
• Enough tissue samples to perform gene analysis

Exclusion Criteria

• Small cell lung cancer
• Pregnant or breast-feeding women
• Any unstable systemic disease
• Patients with exposure to investigational drug therapy or other concurrent anticancer therapy outside of this trial

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
B	neoadjuvant gemcitabine/carboplatin therapy	Non-erlotinib targeted NSCLC population based on EGFR gene analysis
A	neoadjuvant erlotinib therapy	Erlotinib targeted NSCLC population based on EGFR gene analysis(EGFR gene status: activating mutation)

Primary Outcome Measures

Name	Time	Method
Response to Neoadjuvant Erlotinib Therapy	a week after completion of the induction erlotinib therapy

Secondary Outcome Measures

Name	Time	Method
Toxicity of Neoadjuvant Erlotinib Therapy and postoperative complications	one months after thoractomy
disease free survival	every 3 months
overall survival	every 3 months
complete resection rate	7 days after thoractomy

Trial Locations

Locations (1)

Guangdong General Hospital; 🇨🇳 Guangzhou, Guangdong, China