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

Sponsor
Guangdong Provincial People's Hospital
Study ID
NCT00600587
Phase
PHASE2
Status
Completed

Conditions

  • Carcinoma, Non-Small-Cell Lung

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • neoadjuvant erlotinib therapy — DRUG
    150mg erlotinib taken once daily and continued uninterrupted for 42 days before evaluation/thoracotomy/radiotherapy.
  • neoadjuvant gemcitabine/carboplatin therapy — DRUG
    3 cycles of neoadjuvant gemcitabine(1250mg/m2,d1,d8)/carboplatin(AUC=5,day1) chemotherapy before evaluation/thoracotomy/radiotherapy.

Study Details

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.

Key Dates

First listed
Jan 25, 2008
Start date
Sep 30, 2007
Status verified
Jun 2013
Primary completion
Jun 30, 2013
Completion
Jun 30, 2013

Study Design

Enrollment
24 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT

Arms

  • Experimental: A
    Erlotinib targeted NSCLC population based on EGFR gene analysis(EGFR gene status: activating mutation)
  • Active Comparator: B
    Non-erlotinib targeted NSCLC population based on EGFR gene analysis

Primary Outcome Measure

Response to Neoadjuvant Erlotinib Therapy [ Time Frame: a week after completion of the induction erlotinib therapy ]

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