Induction Erlotinib Therapy in Stage III A (N2) Non-Small Cell Lung Cancer (NSCLC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00600587
Recruitment Status : Completed
First Posted : January 25, 2008
Last Update Posted : June 25, 2013
Information provided by (Responsible Party):
Wen-zhao ZHONG, Guangdong General Hospital

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.

Condition or disease Intervention/treatment Phase
Carcinoma, Non-Small-Cell Lung Drug: neoadjuvant erlotinib therapy Drug: neoadjuvant gemcitabine/carboplatin therapy Phase 2

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Non-Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : September 2007
Actual Primary Completion Date : June 2013
Actual Study Completion Date : June 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer
U.S. FDA Resources

Arm Intervention/treatment
Experimental: A
Erlotinib targeted NSCLC population based on EGFR gene analysis(EGFR gene status: activating mutation)
Drug: neoadjuvant erlotinib therapy
150mg erlotinib taken once daily and continued uninterrupted for 42 days before evaluation/thoracotomy/radiotherapy.
Other Name: tarceva
Active Comparator: B
Non-erlotinib targeted NSCLC population based on EGFR gene analysis
Drug: neoadjuvant gemcitabine/carboplatin therapy
3 cycles of neoadjuvant gemcitabine(1250mg/m2,d1,d8)/carboplatin(AUC=5,day1) chemotherapy before evaluation/thoracotomy/radiotherapy.
Other Name: gemzar

Primary Outcome Measures :
  1. Response to Neoadjuvant Erlotinib Therapy [ Time Frame: a week after completion of the induction erlotinib therapy ]

Secondary Outcome Measures :
  1. disease free survival [ Time Frame: every 3 months ]
  2. overall survival [ Time Frame: every 3 months ]
  3. complete resection rate [ Time Frame: 7 days after thoractomy ]
  4. Toxicity of Neoadjuvant Erlotinib Therapy and postoperative complications [ Time Frame: one months after thoractomy ]

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00600587

China, Guangdong
Guangdong General Hospital
Guangzhou, Guangdong, China, 510080
Sponsors and Collaborators
Guangdong Provincial People's Hospital
Principal Investigator: Yi-long WU, MD Guangdong Lung Cancer Institute, Guangdong Lung Cancer Institute, Guangdong Academy of Medical Sciences
Study Chair: Xue-ning YANG, MD Guangdong Lung Cancer Institute, Guangdong Lung Cancer Institute, Guangdong Academy of Medical Sciences
Study Director: Wen-zhao ZHONG, MD Guangdong Lung Cancer Institute, Guangdong Lung Cancer Institute, Guangdong Academy of Medical Sciences


Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Wen-zhao ZHONG, Guangdong General Hospital Identifier: NCT00600587     History of Changes
Other Study ID Numbers: CSLC-0702
First Posted: January 25, 2008    Key Record Dates
Last Update Posted: June 25, 2013
Last Verified: June 2013

Keywords provided by Wen-zhao ZHONG, Guangdong General Hospital:
Carcinoma, Non-Small-Cell Lung
Genes, erbB-1
tyrosine kinase inhibitor
Neoadjuvant Therapy

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Erlotinib Hydrochloride
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Protein Kinase Inhibitors