Non-small Cell Lung Cancer MetastaticMENTORNCT01523340
A Prospective Observational Study Evaluating c-MET Expression and EGFR Gene Mutation Correlation With Erlotinib Response
An observational study of Non-small Cell Lung Cancer Metastatic and Non-small Cell Lung Cancer Recurrent, run by Chonnam National University Hospital at 1 site in South Korea.
Trial summary
1. Trial design: Prospective observational study 2. 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 3. Read more about this study
- Who is it for?
- Ages 19 to 80 years
- Conditions the study is for
- Non-small Cell Lung Cancer Metastatic, Non-small Cell Lung Cancer Recurrent
- How many people
- 196 participants
- Where
- 1 siteSouth Korea
- Study dates
- Sep 2011to Nov 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older 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
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Chonnam National University Hwasun Hospital
Hwasun, 58128
About this study
Official title: Phase 4 Study of Response to EGFR-TKI and Correlation With C-met Expression and EGFR Gene Mutation in NSCLC Patients Treated With Erlotinib
- 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
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Erlotinib treatment | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2012 (estimated)
- Study startSep 2011
- Primary completionSep 2014
- Study completionNov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-small Cell Lung Cancer MetastaticStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 196 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chonnam National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Roche Pharma AG
- Responsible party
- Principal investigator, Young-Chul Kim, Chonnam National University Hospital
- Investigators
- Young-Chul Kim, MD, PhD, Principal investigator, Chonnam National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01523340
- Sponsor's protocol ID
- MENTOR_2011
- Acronym
- MENTOR
- Status last verified
- Aug 2021
- First submitted
- 5 Jan 2012
- Last updated
- 3 Aug 2021
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 4 Study of Response to EGFR-TKI and Correlation With C-met Expression and EGFR Gene Mutation in NSCLC Patients Treated With Erlotinib
- ClinicalTrials.gov ID
- NCT01523340
- Acronym / sponsor ID
- MENTOR / MENTOR_2011
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 196 participants (actual)
- Lead sponsor
- Chonnam National University HospitalUniversity, hospital or other
- Collaborators
- Roche Pharma AG
- Study start
- Sep 2011 (actual)
- Primary completion
- Sep 2014 (actual)
- Study completion
- Nov 2017 (actual)
- First posted
- 1 Feb 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Erlotinib treatment | – | – |
Who may qualify
- Ages
- 19 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older 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
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The rates of C-met expression/amplification and EGFR gene mutations
Time frame: Average of 1 year
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Young-Chul Kim, MD, PhD principal investigator
Chonnam National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non-small Cell Lung Cancer Metastatic and Non-small Cell Lung Cancer Recurrent, run by Chonnam National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The rates of C-met expression/amplification and EGFR gene mutations (time frame: Average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2021.