Genetics of EGFR (Epidermal Growth Factor Receptor) Mutation Study

NCT01838577 | Unknown

• 1 other identifier: EORTC-08114
• Study Type: observational
• Target: 2,000
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

EGFR Mutation Positive Non Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• For the second objective, the primary endpoint is Overall survival (OS)

  5 years from FPI

Study Arms (2)

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).

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• European Organisation for Research and Treatment of Cancer - EORTC: lead

Study Sites (1)

Royal Marsden

Sutton, United Kingdom

Location

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood samples

Study Officials

• Sanjay Popat, MD

  Royal Marsden Hospital, Chelsea, London, UK

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 19, 2013
• First Posted: April 24, 2013
• Study Start: September 1, 2013
• Primary Completion: December 1, 2021
• Study Completion: March 1, 2022
• Last Updated: March 9, 2021

Record last verified: 2021-03

Locations

GB (1)