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

Non Small Cell Lung Cancer Clinical Trial

— ML25444  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01217619
• Other study ID #: ML25444
• Status: Completed
• Phase: Phase 2
• First received: October 7, 2010
• Last updated: September 11, 2017
• Start date: March 2, 2011
• Est. completion date: October 30, 2016

Study information

• Verified date: September 2017
• Source: Shanghai Chest Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: October 30, 2016
• Est. primary completion date: June 30, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Non Small Cell Lung Cancer

Intervention

Drug:
• erlotinib
erlotinib 150mg/d continuously for 56 days

Locations

Country	Name	City	State
China	Shanghai Chest Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Baohui Han

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	radical resection rate	To evaluate radical resection rate of Tarceva as neoadjuvant treatment in patient with EBUS confirmed stage ?A N2 NSCLC with EGFR mutation in exon 19 or 21.	operation after effective neoadjuvant treatment of tarceva for 56 days
Secondary	Pathological Complete Remission	To evaluate Pathological Complete Remission (pCR) rate of Tarceva as neoadjuvant treatment in patient with EBUS confirmed stage ?A N2 NSCLC with EGFR mutation in exon 19 or 21.	operation after effective neoadjuvant treatment of tarceva for 56 days
Secondary	Objective Response Rate	To evaluate Objective Response Rate (ORR) of Tarceva as neoadjuvant treatment in patient with EBUS confirmed stage ?A N2 NSCLC with EGFR mutation in exon 19 or 21.	Objective Response Rate measured by RECIST criteria in ITT population treated by erlotinib
Secondary	disease free survival	To evaluate disease free survival(DFS) of Tarceva as neoadjuvant treatment in patient with EBUS confirmed stage ?A N2 NSCLC with EGFR mutation in exon 19 or 21.	From surgery to disease relapse or death
Secondary	overall survival	To evaluate overall survival(OS) of Tarceva as neoadjuvant treatment in patient with EBUS confirmed stage ?A N2 NSCLC with EGFR mutation in exon 19 or 21.	From study treatment to death due to any cause
Secondary	quality of life	To evaluate quality of life(QOL) of Tarceva as neoadjuvant treatment in patient with EBUS confirmed stage ?A N2 NSCLC with EGFR mutation in exon 19 or 21.	During study treatment period
Secondary	safety profile	To evaluate the safety profile using NCI CTC AE(version 4.0)	For all the patient accepted study treatment
Secondary	explorative biomarkers	To evalutate the relationship between biomarker and Tarceva neoadjuvent treatment efficacy (TBD).	During study conduction period