Carcinoma, Non-Small-Cell Lung
Conditions
Keywords
Carcinoma, Non-Small-Cell Lung, Genes, erbB-1, tyrosine kinase inhibitor, Neoadjuvant Therapy
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.
Interventions
DRUGneoadjuvant erlotinib therapy
150mg erlotinib taken once daily and continued uninterrupted for 42 days before evaluation/thoracotomy/radiotherapy.
DRUGneoadjuvant gemcitabine/carboplatin therapy
3 cycles of neoadjuvant gemcitabine(1250mg/m2,d1,d8)/carboplatin(AUC=5,day1) chemotherapy before evaluation/thoracotomy/radiotherapy.
Sponsors
Guangdong Provincial People's Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Response to Neoadjuvant Erlotinib Therapy | a week after completion of the induction erlotinib therapy |
Secondary
| Measure | Time frame |
|---|---|
| disease free survival | every 3 months |
| overall survival | every 3 months |
| complete resection rate | 7 days after thoractomy |
| Toxicity of Neoadjuvant Erlotinib Therapy and postoperative complications | one months after thoractomy |
Countries
China
Outcome results
None listed