Comparison of Sequencing and PNA Clamping of EGFR Gene in Patients With Non-Small Cell Type Lung Cancer

• Conditions: Non-Small Cell Lung Cancer

• Registration Number: NCT01767974
• Lead Sponsor: Chonnam National University Hospital

Brief Summary

Using DNA acquired from tumor tissue, sequencing and PNA-clamping for EGFR gene will be performed. The detection rates of EGFR mutation will be compared using paired samples.

Detailed Description

Single arm, open label, prospective, observational study of gefitinib treatment for locally advanced (stage IIIB) or IV (metastatic) or relapsed NSCLC patients.

Using DNA acquired from tumor tissue, sequencing and PNA-clamping for EGFR gene will be performed. The detection rates of EGFR mutation will be compared using paired samples.

Study Timeline

• Status Verified: 2013-01
• Study Start: 2013-01
• Study First Submitted: 2013-01-11
• Study First Submitted QC: 2013-01-11
• Last Update Submitted: 2013-01-11
• Study First Posted: 2013-01-15
• Last Update Posted: 2013-01-15
• Primary Completion: 2014-12
• Study Completion: 2015-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 140

Inclusion Criteria

• Locally advanced stage IIIB not suitable for curative therapy or stage IV (metastatic) disease or relapsed NSCLC
• ECOG Performance status 0~2.
• Written Informed Consent
• Female or male patients aged 18 years or over, eligible for treatment for NSCLC

Exclusion Criteria

• Previous exposure to EGFR-TKI
• Concomitant use of other anti-cancer drugs with EGFR-TKI
• Patients without available Tumor DNA
• As judged by the investigator, any evidence of severe or uncontrolled systemic disease (e.g. unstable or uncompensated respiratory, cardiac, hepatic, or renal disease)
• Evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the subject to participate in the study
• Pregnancy or breast-feeding women (women of child¬bearing potential). Women of childbearing potential must practice acceptable methods of birth control to prevent pregnancy.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Detection rate of EGFR mutation	two weeks	To prove higher detection rate of EGFR mutation with PNA clamping compared with sequencing

Secondary Outcome Measures

Name	Time	Method
Verification of PNA positive casese	Two weeks	To analyze the Sequencing negative/PNA clamping positive group (where sample is available) with another sensitive technique COBAS test

Trial Locations

Locations (1)

Chonnam National University Hwasun Hospital; 🇰🇷 Hwasun-Gun, Jeonnam, Korea, Republic of