A Single Arm, One Center, Phase Ⅱ Study of Erlotinib as Neoadjuvent Treatment in Patients With Endobronchial Ultrasound Confirmed Stage ⅢA N2 NSCLC With EGFR Mutation in Exon 19 or 21
18 Years
N/A
Both
Non Small Cell Lung Cancer
Trial Information
A Single Arm, One Center, Phase Ⅱ Study of Erlotinib as Neoadjuvent Treatment in Patients With Endobronchial Ultrasound Confirmed Stage ⅢA N2 NSCLC With EGFR Mutation in Exon 19 or 21
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 by DNA sequencing. The patients with EGFR mutation in exon 19 or 21 will be
enrolled in this study.
Neoadjuvant treatment phase:
Patient will receive erlotinib 150mg/day. Treatment will be scheduled to continue for a
total of 8 weeks or disease progression or unacceptable toxicities.
Surgery treatment phase:
Tumor response will be evaluated with CT scan after 8 weeks of induction treatment. The
patients with responsive disease considered to be technique resectable will undergo
resection.
Post-surgery phase:
It is the discretion of the investigator whether the patient is a candidate for
post-operative treatment which is considered to be in the best interest of the patients. It
is recommended that patients with positive margins or residual tumor after surgery should
receive radiation therapy. Patients after surgery will receive long-term follow-up including
chest CT scan every 3 months for up to 2 years.
Inclusion Criteria:
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 Criteria:
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.
Type of Study:
Interventional
Study Design:
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Screening
Outcome Measure:
radical resection rate
Outcome Description:
To evaluate radical resection rate of Tarceva as neoadjuvant treatment in patient with EBUS confirmed stage ⅢA N2 NSCLC with EGFR mutation in exon 19 or 21.
Outcome Time Frame:
operation after effective neoadjuvant treatment of tarceva for 56 days
Safety Issue:
No
Principal Investigator
Baohui Han, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Shanghai Chest Hospital
Authority:
China: Ministry of Health
Study ID:
ML25444
NCT ID:
NCT01217619
Start Date:
March 2011
Completion Date:
January 2017
Related Keywords:
- Non Small Cell Lung Cancer
- neoadjuvant treatment
- Carcinoma, Non-Small-Cell Lung
- Lung Neoplasms
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