Overview

This trial is active, not recruiting.

Condition non small cell lung cancer
Treatment erlotinib
Phase phase 2
Target EGFR
Sponsor Baohui Han
Start date March 2011
End date November 2014
Trial size 25 participants
Trial identifier NCT01217619, ML25444

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Single-arm
erlotinib Tarceva
erlotinib 150mg/d continuously for 56 days

Primary Outcomes

Measure
radical resection rate
time frame: operation after effective neoadjuvant treatment of tarceva for 56 days

Secondary Outcomes

Measure
Pathological Complete Remission
time frame: operation after effective neoadjuvant treatment of tarceva for 56 days
Objective Response Rate
time frame: Objective Response Rate measured by RECIST criteria in ITT population treated by erlotinib
disease free survival
time frame: From surgery to disease relapse or death
overall survival
time frame: From study treatment to death due to any cause
quality of life
time frame: During study treatment period
safety profile
time frame: For all the patient accepted study treatment
explorative biomarkers
time frame: During study conduction period

Eligibility Criteria

Male or female participants at least 18 years old.

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.

Additional Information

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
Principal investigator Baohui Han, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in February 2015.
Information provided to ClinicalTrials.gov by Shanghai Chest Hospital.