Clinical trial NCT00600587: Induction Erlotinib Therapy in Stage III A (N2) Non-Small Cell Lung Cancer (NSCLC)
Official title: Phase Ⅱ Study of Induction Erlotinib Therapy in Stage III A(N2) Non-small Cell Lung Cancer Proceeding to Mediastinoscopy/PET and Thoracotomy/Radiotherapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Carcinoma, Non-Small-Cell Lung
Keywords: Carcinoma, Non-Small-Cell Lung
Genes, erbB-1
tyrosine kinase inhibitor
Neoadjuvant Therapy
Lead sponsor: GuangdongPPH
Sponsor class: UNKNOWN
First posted: 2008-01-25
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Response to Neoadjuvant Erlotinib Therapy
timeFrame: a week after completion of the induction erlotinib therapy
Secondary outcomes:
measure: disease free survival
timeFrame: every 3 months
measure: overall survival
timeFrame: every 3 months
measure: complete resection rate
timeFrame: 7 days after thoractomy
measure: Toxicity of Neoadjuvant Erlotinib Therapy and postoperative complications
timeFrame: one months after thoractomy
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Guangdong General Hospital
state: Guangdong
Study officials:
affiliation: Guangdong Lung Cancer Institute, Guangdong Lung Cancer Institute, Guangdong Academy of Medical Sciences
name: Yi-long WU, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Guangdong Lung Cancer Institute, Guangdong Lung Cancer Institute, Guangdong Academy of Medical Sciences
name: Xue-ning YANG, MD
role: STUDY_CHAIR
affiliation: Guangdong Lung Cancer Institute, Guangdong Lung Cancer Institute, Guangdong Academy of Medical Sciences
name: Wen-zhao ZHONG, MD
role: STUDY_DIRECTOR
References:
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citation: Mok TS, Wu YL, Thongprasert S, Yang CH, Chu DT, Saijo N, Sunpaweravong P, Han B, Margono B, Ichinose Y, Nishiwaki Y, Ohe Y, Yang JJ, Chewaskulyong B, Jiang H, Duffield EL, Watkins CL, Armour AA, Fukuoka M. Gefitinib or carboplatin-paclitaxel in pulmonary adenocarcinoma. N Engl J Med. 2009 Sep 3;361(10):947-57. doi: 10.1056/NEJMoa0810699. Epub 2009 Aug 19.
citation: Robinson LA, Wagner H Jr, Ruckdeschel JC; American College of Chest Physicians. Treatment of stage IIIA non-small cell lung cancer. Chest. 2003 Jan;123(1 Suppl):202S-220S. doi: 10.1378/chest.123.1_suppl.202s.
citation: Zhong W, Yang X, Yan H, Zhang X, Su J, Chen Z, Liao R, Nie Q, Dong S, Zhou Q, Yang J, Tu H, Wu YL. Phase II study of biomarker-guided neoadjuvant treatment strategy for IIIA-N2 non-small cell lung cancer based on epidermal growth factor receptor mutation status. J Hematol Oncol. 2015 May 17;8:54. doi: 10.1186/s13045-015-0151-3.