Lung cancer screening for family members of people with mutation-driven lung cancer

Lung Cancer Screening of Family Members of Patients With Mutation-Driven Lung Cancer

This project will use low-dose CT scans to see if immediate family members aged 40–80 of people with driver-mutated lung cancer have inherited risk or early lung cancer.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 1753 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: University of California, Irvine (Academic / other)
• Locations: 1 site (Orange, California)
• Trial ID: NCT07062172 on ClinicalTrials.gov

What this trial studies

This is a single-arm screening effort that enrolls index patients with a confirmed driver mutation and invites their first-degree relatives for screening. Eligible relatives (ages 40–80) with under 20 pack-years smoking history undergo a low-dose chest CT to look for early lung cancer. The study collects questionnaire and imaging data to explore whether certain driver mutations cluster in families and whether screening can detect tumors early. The program is conducted at the Chao Family Comprehensive Cancer Center at UC Irvine.

Who should consider this trial

Good fit: Ideal candidates are first-degree relatives (ages 40–80) of someone with a confirmed lung cancer driver mutation who have smoked less than 20 pack-years and can undergo a low-dose chest CT.

Not a fit: People outside the 40–80 age range, those with 20 pack-years or more smoking history, non–first-degree relatives, or those without a family member who has a confirmed driver mutation are unlikely to gain benefit from this protocol.

Why it matters

Potential benefit: If successful, this could find lung cancer earlier in relatives and help determine whether specific driver mutations can be inherited, guiding earlier or targeted screening.

How similar studies have performed: Low-dose CT screening has reduced lung cancer mortality in high-risk smokers, but applying it specifically to screen relatives of driver-mutated lung cancers is a novel and largely untested approach.

Eligibility criteria

Cohort A:

Inclusion Criteria:

* Current diagnosis of lung cancer with a driver mutation.
* Known driver mutation (e.g. via NGS, PCR, IHC, FISH, RT-PCR etc.)
* Able and willing to give informed consent.
* Able and willing to complete the screening questionnaire.

Cohort A:

Exclusion Criteria:

* There are no exclusion criteria for Cohort A.

Cohort B:

Inclusion Criteria:

* Age 40 - 80.
* Must have a first degree relative (mother, father, sibling, biological child) eligible for Cohort A. Note: Multiple first degree relatives of a Cohort A eligible participant may be approached for participation into the trial.
* Smoked \< 20 pack years; a. Pack years = numbers of packs per day × number of years smoked; b. One pack year is the equivalent of smoking an average of 20 cigarettes (1 pack) per day for a year.
* Be able to undergo a low dose chest CT scan.
* If an upper respiratory infection (pneumonia, COVID19, flu, etc.) occurred in the last 3 months, this infection must have resolved by time of enrollment.
* Able and willing to provide informed consent.
* Able and willing to comply with the protocol requirements

Cohort B:

Exclusion Criteria:

* Previous history of lung cancers.
* Symptoms suggestive of presence of current lung cancer, including (but not limited to): unexplained weight loss of over 15 pounds within the last 12 months or unexplained hemoptysis.
* Pregnant at time of enrollment.
* History of any type of cancer within 5 years, with the exception of in situ carcinomas and non-melanoma skin cancers (if excised).
* Current smoker.
* Smoked ≥ 20 pack years.
* Had a chest CT scan within 1 year of study entry.

Where this trial is running

Orange, California

• Chao Family Comprehensive Cancer Center University of California, Irvine — Orange, California, United States (Recruiting)

Study contacts

• Study coordinator: Chao Family Comprehensive Cancer Center University of California, Irvine

Conditions Lung Cancer; Driver Mutation