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

Guangdong Provincial People's Hospital (Guangdong Provincial Academy of Medical Sciences)

Status and phase: Completed; Phase 2

Conditions: Carcinoma, Non-Small-Cell Lung

Treatments: Drug: neoadjuvant erlotinib therapy; Drug: neoadjuvant gemcitabine/carboplatin therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT00600587

CSLC-0702

tarceva-123456-1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 24 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

---

24 participants in 2 patient groups

A

Experimental group

Description:

Erlotinib targeted NSCLC population based on EGFR gene analysis(EGFR gene status: activating mutation)

Treatment:

Drug: neoadjuvant erlotinib therapy

B

Active Comparator group

Description:

Non-erlotinib targeted NSCLC population based on EGFR gene analysis

Treatment:

Drug: neoadjuvant gemcitabine/carboplatin therapy