Erlotinib as Neoadjuvant Treatment in Patients With Stage ⅢA N2 NSCLC With Activating EGFR Mutation. (ML25444)
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Non Small Cell Lung Cancer |
Drug: erlotinib |
Phase 2 |
| Study Type: | Interventional |
| 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.
| Estimated Enrollment: | 44 |
| 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) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Erlotinib
Single-arm
|
Drug: erlotinib
erlotinib 150mg/d continuously for 56 days
Other Name: Tarceva
|
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 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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations| Contact: Baohui Han, MD | 86-21-62821990 ext 61201 | xkyyhan@gmail.com |
| China, Shanghai | |
| Shanghai Chest Hospital | Recruiting |
| Shanghai, Shanghai, China, 200030 | |
| Contact: Baohui Han, MD 86-21-62821990 ext 61201 xkyyhan@gmail.com | |
| Principal Investigator: Baohui Han, MD | |
| Principal Investigator: | Baohui Han, MD | Shanghai Chest Hospital |
More Information
No publications provided
| Responsible Party: | Baohui Han, Vice President, Shanghai Chest Hospital |
| ClinicalTrials.gov Identifier: | NCT01217619 History of Changes |
| Other Study ID Numbers: | ML25444 |
| Study First Received: | October 7, 2010 |
| Last Updated: | March 6, 2012 |
| Health Authority: | China: Ministry of Health |
Keywords provided by Shanghai Chest Hospital:
|
neoadjuvant treatment |
Additional relevant MeSH terms:
|
Carcinoma, Non-Small-Cell Lung Lung Neoplasms Carcinoma, Bronchogenic Bronchial Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms |
Lung Diseases Respiratory Tract Diseases Erlotinib Protein Kinase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 19, 2013