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
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
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.
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Screening
radical resection rate
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.
operation after effective neoadjuvant treatment of tarceva for 56 days
Baohui Han, MD
Shanghai Chest Hospital
China: Ministry of Health