Know Cancer

forgot password

Phase Ⅱ Study of Induction Erlotinib Therapy in Stage III A(N2) Non-small Cell Lung Cancer Proceeding to Mediastinoscopy/PET and Thoracotomy/Radiotherapy

Phase 2
18 Years
Not Enrolling
Carcinoma, Non-Small-Cell Lung

Thank you

Trial Information

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.

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

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Response to Neoadjuvant Erlotinib Therapy

Outcome Time Frame:

a week after completion of the induction erlotinib therapy

Safety Issue:


Principal Investigator

Yi-long WU, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Guangdong Lung Cancer Institute, Guangdong Lung Cancer Institute, Guangdong Academy of Medical Sciences


China: Ethics Committee

Study ID:




Start Date:

September 2007

Completion Date:

June 2013

Related Keywords:

  • Carcinoma, Non-Small-Cell Lung
  • Carcinoma, Non-Small-Cell Lung
  • Genes, erbB-1
  • tyrosine kinase inhibitor
  • Neoadjuvant Therapy
  • Carcinoma
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms