Phase Ⅱ Study of Induction Erlotinib Therapy in Stage III A(N2) Non-small Cell Lung Cancer Proceeding to Mediastinoscopy/PET and Thoracotomy/Radiotherapy
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.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment
Response to Neoadjuvant Erlotinib Therapy
a week after completion of the induction erlotinib therapy
No
Yi-long WU, MD
Principal Investigator
Guangdong Lung Cancer Institute, Guangdong Lung Cancer Institute, Guangdong Academy of Medical Sciences
China: Ethics Committee
CSLC-0702
NCT00600587
September 2007
June 2013
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