A Prospective Observational Study Evaluating c-MET Expres... | NCT01523340

Studies
A Prospective Observational Study Evaluating c-MET Expression and EGFR Gene Mutation Correlation With Erlotinib Response

NCT01523340

Sponsor

Chonnam National University Hospital

Status

Completed

Last Update Posted

Aug 3, 2021Actual

Enrollment

196Actual

Phase

Not provided

Conditions

Non-small Cell Lung Cancer Metastatic
Non-small Cell Lung Cancer Recurrent

Interventions

Not provided

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2011Actual

Primary Completion Date

Sep 2014Actual

Completion Date

Nov 2017Actual

First Submitted Date

Jan 5, 2012

First Submission Date that Met QC Criteria

Jan 28, 2012

First Posted Date

Feb 1, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 1, 2021

Last Update Posted Date

Aug 3, 2021Actual

Name	Class
Roche Pharma AG	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Trial design: Prospective observational study
Target population: 200 NSCLC patients with histologically or cytologically confirmed stage IV or recurrent NSCLC who have progressive disease after 1st line chemotherapy who consent for study participation and meet the study selection criteria
Primary objective: To investigate C-met expression/amplification and EGFR gene mutations in NSCLC patients treated with Erlotinib
- C-met expression by IHC C-met amplification by SISH EGFR mutation by real time PCR
We will also assess the correlation of EGFR mutations and c-MET with clinical outcome (Overall Response Rate, Progression Free survival )
Duration of Trial Recruitment: 2 years

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

196Actual

Label	Type	Description	Intervention Names
Erlotinib treatment

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The rates of C-met expression/amplification and EGFR gene mutations	To investigate C-met expression/amplification and EGFR gene mutations in NSCLC patients treated with Erlotinib : C-met expression by IHC C-met amplification by SISH EGFR mutation by real time PCR	Average of 1 year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Informed consent
19~80 year old male or female
Histologically proven advanced or metastatic NSCLC
Failed to 1st line chemotherapy
Tumor tissue for genetic analysis
Evaluable target lesion by RECIST v1.1
ECOG performance from 0 to 3
Expected survival more than 12 weeks

Exclusion Criteria:

Previous treatment of EGFR-tyrosine kinase inhibitors
Severe hypersensitivity to erlotinib
Residual toxicities (above grade 2) after previous chemotherapy
Total bilirubin more than 1.5x of upper normal limit Liver function tests more than 2.5x of upper normal limits

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Patients with histologically or cytologically confirmed stage IV or recurrent NSCLC who have progressive disease after 1st line chemotherapy who consent for study participation and meet the study selection criteria

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Young-Chul Kim, MD, PhD	Chonnam National University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Chonnam National University Hwasun Hospital		Hwasun		58128	South Korea