EGFR Mutation Positive Non Small Cell Lung CancerGEMNCT01838577
Genetics of EGFR (Epidermal Growth Factor Receptor) Mutation Study
An observational study of EGFR Mutation Positive Non Small Cell Lung Cancer, run by European Organisation for Research and Treatment of Cancer - EORTC at 1 site in United Kingdom.
Trial summary
The investigators wish to document the distribution of EGFR somatic mutations, and assess the relationship between specific genotype, clinical demographic, therapy, and survival, in a large cohort of EGFR mutant NSCLC. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- EGFR Mutation Positive Non Small Cell Lung Cancer
- How many people
- 2,000 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Sep 2013to Mar 2022
- How long will I take part?
- 3 Years
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Case cohort: Patients with proven EGFR mutation in exons 18-21 from tumor material. Control cohort: Patients known to be somatic EGFR "wild-type," i.e. no mutation detected in exons 18-21 from tumor material.
- Histologically or cytologically diagnosed NSCLC, all histologies are acceptable.
- Patients can be included in the study with any disease stage and at any time during the disease course.
- Any type (surgery, RadioTherapy, chemotherapy, targeted agents) of previous treatment and any line of treatment are eligible.
- Age ≥18 years.
Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol; those conditions should be discussed with the patient before registration in the trial.
Before patient registration, written informed consent must be given according to ICH/GCP (International Conference on Harmonisation/Good Clinical Practice), and national/local regulations.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Genetics of EGFR Mutation Study (GEM): a Translational Study of the EORTC Lung Group.
The investigators wish to document the distribution of EGFR somatic mutations, and assess the relationship between specific genotype, clinical demographic, therapy, and survival, in a large cohort of EGFR mutant NSCLC.
The investigators also wish to comprehensively investigate the relationship between germline DNA and risk of EGFR mutant NSCLC developing, through a GWAS (Genome-Wide Association Studies) and candidate gene approach, and explore the relationship between germline DNA and clinical outcome, in order to potentially identify germline genetic modifiers of EGFR TKI (Tyrosine Kinase Inhibitor) outcome.
Read the detailed description
Objective 1: To identify germline allelic DNA variation associated with somatic EGFR mutation in NSCLC, Objective 2: Correlation between germline allelic variants and survival in EGFR somatic mutant NSCLC.
Objective 3: Study germline allelic DNA variation associated with never /ex light smoking NSCLC.
Objective 4: Catalogue distribution of somatic EGFR mutant genotypes in 1,000 EGFR mutant NSCLC cases and describe their relationship to clinical outcome.
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 |
|---|---|---|
| Case cohort | Patients with proven EGFR mutation in exons 18-21 from tumor material. Patients with unknown or failed tumor EGFR genotyping will be ineligible. Patients subsequently undergoing re-genotyping which demonstrates an EGFR mutation will become eligible for the "case" cohort. No known somatic KRAS, HER2, LKB1, BRAF, or PI3K, mutation or ALK gene rearrangement (or ALK3+ immunohistochemistry). If these mutations are known to be present the patient will be ineligible. However, patients will not be tested specifically for these mutations for this study and patients with unknown status are acceptable. If patients are subsequently tested after enrollment and found to harbor any of these mutations they will be considered ineligible and will be replaced. No known Li Fraumeni, Li Fraumeni-like, or Peutz Jeghers syndrome family, or known germline carriers of mutant LKB1 or TP53. Patients will not have to be tested specifically for these syndromes to be eligible for this study. | |
| Control cohort | Patients known to be somatic EGFR "wild-type," i.e. no mutation detected in exons 18-21 from tumor material. Patients with unknown or failed EGFR genotyping will be ineligible. Patients subsequently undergoing re-genotyping which demonstrates an EGFR wild-type will become eligible for the "control" cohort. Never smoker (<100 cigarettes in lifetime) or ex-light smoker (stopped ≥1 year ago and smoked ≤10 pack-years). |
What is being measured
The primary outcome is the main question the study is designed to answer.
For the second objective, the primary endpoint is Overall survival (OS)
Measured: 5 years from FPI
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2013 (estimated)
- Study startSep 2013
- Primary completionDec 2021 (estimated)
- Study completionMar 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EGFR Mutation Positive Non Small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by European Organisation for Research and Treatment of Cancer - EORTCThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,000 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Sanjay Popat, MD, Principal investigator, Royal Marsden Hospital, Chelsea, London, UK
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01838577
- Sponsor's protocol ID
- EORTC-08114
- Acronym
- GEM
- Status last verified
- Mar 2021
- First submitted
- 19 Apr 2013
- Last updated
- 9 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Genetics of EGFR Mutation Study (GEM): a Translational Study of the EORTC Lung Group.
- ClinicalTrials.gov ID
- NCT01838577
- Acronym / sponsor ID
- GEM / EORTC-08114
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- European Organisation for Research and Treatment of Cancer - EORTCResearch network
- Study start
- Sep 2013
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Mar 2022 (estimated)
- First posted
- 24 Apr 2013 (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.
The investigators wish to document the distribution of EGFR somatic mutations, and assess the relationship between specific genotype, clinical demographic, therapy, and survival, in a large cohort of EGFR mutant NSCLC.
The investigators also wish to comprehensively investigate the relationship between germline DNA and risk of EGFR mutant NSCLC developing, through a GWAS (Genome-Wide Association Studies) and candidate gene approach, and explore the relationship between germline DNA and clinical outcome, in order to potentially identify germline genetic modifiers of EGFR TKI (Tyrosine Kinase Inhibitor) outcome.
Detailed description
Objective 1: To identify germline allelic DNA variation associated with somatic EGFR mutation in NSCLC, Objective 2: Correlation between germline allelic variants and survival in EGFR somatic mutant NSCLC.
Objective 3: Study germline allelic DNA variation associated with never /ex light smoking NSCLC.
Objective 4: Catalogue distribution of somatic EGFR mutant genotypes in 1,000 EGFR mutant NSCLC cases and describe their relationship to clinical outcome.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Case cohort | – | –Patients with proven EGFR mutation in exons 18-21 from tumor material. Patients with unknown or failed tumor EGFR genotyping will be ineligible. Patients subsequently undergoing re-genotyping which demonstrates an EGFR mutation will become eligible for the "case" cohort. No known somatic KRAS, HER2, LKB1, BRAF, or PI3K, mutation or ALK gene rearrangement (or ALK3+ immunohistochemistry). If these mutations are known to be present the patient will be ineligible. However, patients will not be tested specifically for these mutations for this study and patients with unknown status are acceptable. If patients are subsequently tested after enrollment and found to harbor any of these mutations they will be considered ineligible and will be replaced. No known Li Fraumeni, Li Fraumeni-like, or Peutz Jeghers syndrome family, or known germline carriers of mutant LKB1 or TP53. Patients will not have to be tested specifically for these syndromes to be eligible for this study. |
| Control cohort | – | –Patients known to be somatic EGFR "wild-type," i.e. no mutation detected in exons 18-21 from tumor material. Patients with unknown or failed EGFR genotyping will be ineligible. Patients subsequently undergoing re-genotyping which demonstrates an EGFR wild-type will become eligible for the "control" cohort. Never smoker (<100 cigarettes in lifetime) or ex-light smoker (stopped ≥1 year ago and smoked ≤10 pack-years). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Case cohort: Patients with proven EGFR mutation in exons 18-21 from tumor material. Control cohort: Patients known to be somatic EGFR "wild-type," i.e. no mutation detected in exons 18-21 from tumor material.
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
For the second objective, the primary endpoint is Overall survival (OS)
Time frame: 5 years from FPI
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2021.
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NSCLC (Non-small Cell Lung Cancer)
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.
Sanjay Popat, MD principal investigator
Royal Marsden Hospital, Chelsea, London, UK
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 EGFR Mutation Positive Non Small Cell Lung Cancer, run by European Organisation for Research and Treatment of Cancer - EORTC at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: status not confirmed, as of the sponsor's last update on 9 Mar 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 United Kingdom. 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?
Results are not available in the source record.
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?
For the second objective, the primary endpoint is Overall survival (OS) (time frame: 5 years from FPI). 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 9 Mar 2021.