Trial | NCT00600587  Report issue

Title

Induction Erlotinib Therapy in Stage III A (N2) Non-Small Cell Lung Cancer (NSCLC)
Phase Ⅱ Study of Induction Erlotinib Therapy in Stage III A(N2) Non-small Cell Lung Cancer Proceeding to Mediastinoscopy/PET and Thoracotomy/Radiotherapy

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    24
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.
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 Started
Sep 30
2007
Primary Completion
Jun 30
2013
Study Completion
Jun 30
2013
Last Update
Jun 25
2013
Estimate

Drug neoadjuvant erlotinib therapy

150mg erlotinib taken once daily and continued uninterrupted for 42 days before evaluation/thoracotomy/radiotherapy.

  • Other names: tarceva

Drug neoadjuvant gemcitabine/carboplatin therapy

3 cycles of neoadjuvant gemcitabine(1250mg/m2,d1,d8)/carboplatin(AUC=5,day1) chemotherapy before evaluation/thoracotomy/radiotherapy.

  • Other names: gemzar

A Experimental

Erlotinib targeted NSCLC population based on EGFR gene analysis(EGFR gene status: activating mutation)

B Active Comparator

Non-erlotinib targeted NSCLC population based on EGFR gene analysis

Criteria 

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
No Results Posted