A Phase 2 interventional study of neoadjuvant erlotinib therapy and neoadjuvant gemcitabine/carboplatin therapy in Carcinoma, Non-Small-Cell Lung, sponsored by Guangdong Provincial People's Hospital. Completed at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-06-25.
Sponsored by Guangdong Provincial People's Hospital · Phase 2, Interventional, and Treatment
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.
6,488 studies on the registry are indexed under Carcinoma, Non-Small-Cell Lung; 1,630 are open to participants now.
This study's enrollment of 24 is below the median of 62 across 5,211 interventional studies indexed under Carcinoma, Non-Small-Cell Lung.
Browse Carcinoma, Non-Small-Cell Lung studies →Guangdong Provincial People's Hospital is the lead sponsor of 231 studies on the registry; 101 are open to participants now.
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Exclusion Criteria:
Erlotinib targeted NSCLC population based on EGFR gene analysis(EGFR gene status: activating mutation)
Drug: neoadjuvant erlotinib therapy
Non-erlotinib targeted NSCLC population based on EGFR gene analysis
Drug: neoadjuvant gemcitabine/carboplatin therapy
150mg erlotinib taken once daily and continued uninterrupted for 42 days before evaluation/thoracotomy/radiotherapy.
Also known as: tarceva
3 cycles of neoadjuvant gemcitabine(1250mg/m2,d1,d8)/carboplatin(AUC=5,day1) chemotherapy before evaluation/thoracotomy/radiotherapy.
Also known as: gemzar
Response to Neoadjuvant Erlotinib Therapy
Time frame: a week after completion of the induction erlotinib therapy
disease free survival
Time frame: every 3 months
overall survival
Time frame: every 3 months
complete resection rate
Time frame: 7 days after thoractomy
Toxicity of Neoadjuvant Erlotinib Therapy and postoperative complications
Time frame: one months after thoractomy
This study is completed, as verified in Jun 2013. You cannot join it, but the record below documents what was studied.
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Carcinoma, Non-Small-Cell Lung→
Guangdong Provincial People's Hospital