Who is eligible for clinical trial NCT01754025?

Participants must meet protocol criteria for Lung Cancer. Confirm exact inclusion and exclusion requirements with the study coordinator.

Does clinical trial NCT01754025 provide travel or cost reimbursement?

Check with the site coordinator at the participating facility for travel and lodging stipend availability, and for which routine-care costs are covered.

🏛️ Verified NIH Record • Updated 2025-11-24

INHERIT EGFR - Studying Germline EGFR Mutations (NCT01754025)

🔵 Active, Not Recruiting Interventional Protocol 📊 Observational Clinical Research Sponsor: Dana-Farber Cancer Institute

🩺 Plain-English Summary (8th-Grade Level)

Lung cancer is a common malignancy that is associated with cigarette smoking but can also affect individuals who never smoked. It is not well understood whether there are hereditary risk factors that influence the risk of lung cancer. It has been recently found that a small number of families have an inherited (passed from parent to child) change in one of their genes that may contribute to an increased tendency to develop lung cancers, even in never smokers. In some lung cancer patients this gene, called "EGFR", contains a DNA change known as an "inherited EGFR mutation". Early data indicate that these inherited EGFR mutations may be associated with an increased risk of lung cancer. So far, only a small number of families have been found to carry inherited EGFR mutations. For this reason the risk of lung cancer associated with inherited EGFR mutations is not well understood. Understanding the risk may help investigators find ways of detecting lung cancer sooner or reducing the risk of developing lung cancer. It was recently discovered that lung cancer patients who are found to carry one rare EGFR mutation in their cancer cells, called "T790M", have an increased risk of carrying an inherited EGFR mutation in their normal cells as well. This represents a new strategy for finding individuals and families carrying inherited EGFR mutations. This research study is designed to find cancer patients whose tumors have this EGFR mutation, T790M, to find out if they also have an inherited EGFR mutation. Subjects will not have to undergo a biopsy to participate in this research study. Investigators will collect a saliva specimen from patients with a T790M in their cancer to find out if they also have an inherited EGFR mutation. Study participants found or known to carry an inherited EGFR mutation will have the option of offering their close relative the opportunity to also participate in this study. Close relatives can consider testing to see if they also carry the inherited mutation in their normal cells. Once investigators have identified individuals and relatives that carry inherited EGFR mutations in their genes, investigators will then try to understand the risk of lung cancer and other cancers. Individuals with inherited EGFR mutations will also have the opportunity to participate in future studies related to cancer and other diseases. This study is being funded in part by the Conquer Cancer Foundation of ASCO and the Bonnie J. Addario Lung Cancer Foundation.

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (7 items) and avoid the listed exclusions (6 items).

Location: Dana-Farber Cancer Institute — Boston, Massachusetts

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

To participate in this study a subject must meet the eligibility of one of the following cohorts: Cohort 1 - Cancer patients with T790M in their tumor must both:
Have a diagnosis of cancer of any type (lung cancer or other)
Have an EGFR mutation identified. Either EGFR T790M identified on tumor genotyping of their cancer OR on quantitative plasma genotyping with evidence of high level (\>40% allelic fraction) EGFR T790M OR
Another EGFR mutation previously reported as germline detected on tumor genotyping of their cancer Cohort 2 - Relatives of carriers of germline EGFR mutations are eligible as follows:
First-degree or second-degree relatives of an individual known to carry a germline EGFR mutation (either T790M or other novel germline EGFR mutation)
Third-degree relatives of an individual known to carry a germline EGFR mutation (either T790M or other novel germline EGFR mutation) if the relative has a personal history of lung cancer or another malignancy Cohort 3 - Individuals already known to carry a germline EGFR mutation must:
Have a known germline EGFR mutation (either T790M or other novel germline EGFR mutation)

Usually NOT eligible if any of the following apply:

Exclusion Criteria:
Subjects with lung cancer and an acquired T790M mutation first detected after exposure to an EGFR tyrosine kinase inhibitor such as erlotinib or gefitinib
Subjects who are too ill to complete the study questionnaire or provide the necessary specimen for testing
Subjects who are unable to give informed consent
Subjects who are unable to speak or read English or Brazilian Portuguese
Subjects under the age of 18

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (2 Sites)

Dana-Farber Cancer Institute — Boston, Massachusetts
Vanderbilt-Ingram Cancer Center — Nashville, Tennessee

💰 Cost, Insurance & Patient Rights

100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

🏛️ View Official NIH Record ↗