Status:
COMPLETED
Erlotinib as Neoadjuvant Treatment in Patients With Stage ⅢA N2 NSCLC With Activating EGFR Mutation.
Lead Sponsor:
Baohui Han
Conditions:
Non Small Cell Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This is a single arm, one center, phaseⅡ study evaluating efficacy and safety of erlotinib as neoadjuvent treatment in patients with EBUS confirmed stage ⅢA N2 NSCLC with activating EGFR mutation in e...
Detailed Description
Screening phase: Patients clinically diagnosed as stage ⅢA N2 lung caner by CT technique will be pathologically proven as NSCLC with N2 by EBUS. The pathology specimen will be detected EGFR mutation ...
Eligibility Criteria
Inclusion
- Written informed consent provided. Males or females aged ≥18 years. Able to comply with the required protocol and follow-up procedures, and able to receive oral medications.
- Stage IIIA N2 NSCLC according to the pathological evidence of endobronchial ultrasound(EBUS).
- The biopsy specimen shows EGFR mutation in exon 19 or 21 by DNA sequencing. Measurable disease must be characterized according to RECIST criteria: measurable lesions are defined as those that can be accurately measured in at least one dimension (longest diameter to be recorded) as ≥20cm with conventional techniques (PE, CT, XR, MRI) or as ≥ 10cm with spiral scan.
- ECOG performance status 0-1. Life expectancy ≥12 weeks.
- Female subjects should not be pregnant or breast-feeding.
Exclusion
- The biopsy specimen shows EGFR wildtype in exon 19 or 21 by DNA sequencing. Patients with prior exposure to agents directed at the HER axis (e.g. erlotinib, gefitinib, cetuximab, trastuzumab).
- Patients with prior chemotherapy or therapy with systemic anti-tumour therapy (e.g. monoclonal antibody therapy).
- Known hypersensitivity to Tarceva or any of its recipients.
- Evidence of any other disease, neurological or metabolic dysfunction, physical examination or laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or puts the subject at high risk for treatment-related complications.
- Sexually active males and females(of childbearing potential) unwilling to practice contraception during the study.
Key Trial Info
Start Date :
March 2 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 30 2016
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT01217619
Start Date
March 2 2011
End Date
October 30 2016
Last Update
September 12 2017
Active Locations (1)
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1
Shanghai Chest Hospital
Shanghai, Shanghai Municipality, China, 200030