Erlotinib as Neoadjuvant Treatment in Patients With Stage ⅢA N2 NSCLC With Activating EGFR Mutation. (ML25444)
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 exon 19 or 21.
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Screening
|Official Title:||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|
- radical resection rate [ Time Frame: operation after effective neoadjuvant treatment of tarceva for 56 days ] [ Designated as safety issue: No ]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.
- Pathological Complete Remission [ Time Frame: operation after effective neoadjuvant treatment of tarceva for 56 days ] [ Designated as safety issue: No ]To evaluate Pathological Complete Remission (pCR) rate of Tarceva as neoadjuvant treatment in patient with EBUS confirmed stage ⅢA N2 NSCLC with EGFR mutation in exon 19 or 21.
|Study Start Date:||March 2011|
|Estimated Study Completion Date:||January 2017|
|Estimated Primary Completion Date:||January 2015 (Final data collection date for primary outcome measure)|
erlotinib 150mg/d continuously for 56 days
Other Name: Tarceva
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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01217619
|Contact: Baohui Han, MD||86-21-62821990 ext firstname.lastname@example.org|
|Shanghai Chest Hospital||Recruiting|
|Shanghai, Shanghai, China, 200030|
|Contact: Baohui Han, MD 86-21-62821990 ext 61201 email@example.com|
|Principal Investigator: Baohui Han, MD|
|Principal Investigator:||Baohui Han, MD||Shanghai Chest Hospital|