Erlotinib as Neoadjuvant Treatment in Patients With Stage ⅢA N2 NSCLC With Activating EGFR Mutation. (ML25444)

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2012 by Shanghai Chest Hospital
Sponsor:
Information provided by (Responsible Party):
Baohui Han, Shanghai Chest Hospital
ClinicalTrials.gov Identifier:
NCT01217619
First received: October 7, 2010
Last updated: March 6, 2012
Last verified: March 2012
  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

Resource links provided by NLM:


Further study details as provided by Shanghai Chest Hospital:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01217619

Contacts
Contact: Baohui Han, MD 86-21-62821990 ext 61201 xkyyhan@gmail.com

Locations
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         
Sponsors and Collaborators
Baohui Han
Investigators
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
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung 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 September 30, 2014