Non Small Cell Lung Cancer
Conditions
Keywords
neoadjuvant treatment
Brief 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.
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.
Interventions
DRUGerlotinib
erlotinib 150mg/d continuously for 56 days
Sponsors
Baohui Han
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| radical resection rate | operation after effective neoadjuvant treatment of tarceva for 56 days | 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
| Measure | Time frame | Description |
|---|---|---|
| Objective Response Rate | Objective Response Rate measured by RECIST criteria in ITT population treated by erlotinib | To evaluate Objective Response Rate (ORR) of Tarceva as neoadjuvant treatment in patient with EBUS confirmed stage ⅢA N2 NSCLC with EGFR mutation in exon 19 or 21. |
| disease free survival | From surgery to disease relapse or death | To evaluate disease free survival(DFS) of Tarceva as neoadjuvant treatment in patient with EBUS confirmed stage ⅢA N2 NSCLC with EGFR mutation in exon 19 or 21. |
| overall survival | From study treatment to death due to any cause | To evaluate overall survival(OS) 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 | operation after effective neoadjuvant treatment of tarceva for 56 days | 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. |
| safety profile | For all the patient accepted study treatment | To evaluate the safety profile using NCI CTC AE(version 4.0) |
| explorative biomarkers | During study conduction period | To evalutate the relationship between biomarker and Tarceva neoadjuvent treatment efficacy (TBD). |
| quality of life | During study treatment period | To evaluate quality of life(QOL) of Tarceva as neoadjuvant treatment in patient with EBUS confirmed stage ⅢA N2 NSCLC with EGFR mutation in exon 19 or 21. |
Countries
China
Outcome results
None listed