This research study is studying a new blood test to screen for Epidermal Growth Factor Receptor (EGFR) positive lung cancer in healthy individuals at risk for the disease and who cannot undergo regular lung cancer screening.

The name of the test used in this research study is:

-Circulating free DNA (cfDNA) Assay

The goal of this research study is to evaluate the feasibility of a novel EGFR blood plasma ctDNA screening test among East Asian and Latinx participants at risk for lung cancer and ineligible for regular lung cancer screening. The test looks for a gene change called Epidermal Growth Factor Receptor (EGFR), specifically EGFR L858R and exon 19 deletions, which comprise 85-90% of total EGFR mutations. This study seeks to determine if it is possible to use the blood test to detect this type of lung cancer that might not yet show symptoms.

The research study procedures include screening for eligibility, in-clinic visits, blood tests, and an optional questionnaire and/or focus group.

It is expected that about 1000 people will participate in the blood sample collection, 100 individuals in the survey, and 20 individuals in the focus groups.

Inclusion Criteria (Aims 1, 2, and 3) for Group 1 (50 through 80 years of age):

• Non-tobacco using (currently)
• Self-identify as East Asian (including Southeast Asian) or Hispanic/Latinx.
• East Asian includes those who self-identify as Chinese, Japanese, Korean, Taiwanese, Malaysian
• Southeast Asian includes those who self-identify as Cambodian, Thai, Vietnamese, Filipino
• Latinx includes those who self-identify as a person of Central or South American and the Caribbean including, Cuban, Puerto Rican, and Dominican culture or origin, excluding individuals originating from Spain
• Aims 1 and 2: Able to complete and understand the study's informed consent in English, Mandarin, Cantonese, Japanese, Korean, Vietnamese, Spanish, Portuguese, or Cape Verdean
• Aim 3: Able to complete and understand the study's informed consent and participate in a focus group in English, Mandarin, Vietnamese, or Spanish.

Inclusion Criteria (Aims 1, 2, and 3) for Group 2 (40 through 49 years of age):

• Non-tobacco using (currently)

• Self-identify as East Asian (including Southeast Asian) or Latinx, if any of the following criteria are met:

  • Family history of EGFR positive LC L858R or exon 19
  • Personal history of remote cancer that is not LC or other thoracic malignancies, including thymoma, thymic carcinoma, or sarcoma, as long as it was resolved over 5 years ago
  • History of TB, asthma requiring daily inhaled corticosteroids or chronic bronchitis
  • Symptoms of lung cancer for the past month, including hemoptysis, unexplained weight loss, voice hoarseness, cough or worsening cough, dyspnea or worsening dyspnea

• Excluding individuals who concurrently present with fever, covid/influenza/RSV/adenovirus infection, runny nose, sore throat, productive cough with green or yellow sputum

• Aims 1 and 2: Able to complete and understand the study's informed consent in English, Mandarin, Cantonese, Japanese, Korean, Vietnamese, Spanish, Portuguese, or Cape Verdean

• Aim 3: Able to complete and understand the study's informed consent and participate in a focus group in English, Mandarin, Vietnamese, or Spanish.

Exclusion Criteria (Aims 1, 2, and 3) for Groups 1 and 2:

• Having had a chest CT scan in the last 3 years or having an anticipated chest CT scan during the enrollment period.
• Having a current cancer or history of cancer within the last 5 years, excluding localized non-melanoma skin cancer and breast ductal carcinoma in situ.
• More than 400 lifetime cigarettes (i.e., 20 packs) of smoking or tobacco use
• Adults unable to provide informed consent
• Individuals <40 years of age
• Prisoners
• Pregnant women
• Personal diagnosis of lung cancer
• Not able to be compliant with study requirements

The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: [contact information for Sponsor Investigator or designee]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.

Data can be shared no earlier than 1 year following the date of publication

Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu