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CompletedNCT04640259EoYLCUpdated Aug 4, 2026

Epidemiology of Young Lung Cancer - Survey

An observational study in NSCLC, sponsored by Addario Lung Cancer Medical Institute. Completed at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-04.

Sponsored by Addario Lung Cancer Medical Institute · Observational

Study type
Observational
Model
Case-only
Time perspective
Other
Enrollment
187
Ages
18 Years and older
Sex
All
01

Study summary

This is a 100% virtual (remote), case-case study to explore potential environmental, lifestyle and genetic factors that may be associated with driver mutations of young lung cancer in the U.S.

02

Conditions studied

  • NSCLC
03

In context

Lead sponsor

Addario Lung Cancer Medical Institute is the lead sponsor of 10 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

A minimum of 250 subjects distributed with at least 50 subjects among the most common driver mutation groups will be enrolled into the study:

  1. EGFR (del19 and L858R) - 50 subjects
  2. ROS1 - 50 subjects
  3. ALK - 50 subjects
  4. KRAS - 50 subjects

  5. Other Groups:

    1. Uncommon activating mutation for which specific targeted therapy exists (RET fusion, NTRK fusion, BRAF V600E, MET Exon14 skipping mutations, other activating EGFR mutations) - 25 subjects
    2. Non-targetable other mutations (p53, NF1, ATM, PIK3CA, RB, non-V600E BRAF, NTRK mutation) or no identified mutation. - 25 subjects Subjects with more than one mutation will be included.

Inclusion criteria

  1. Male or female aged 18 years and over; or the age of majority for their residential state at the time of enrollment
  2. Documentation of primary NSCLC, any stage
  3. Less than 50 years of age at the time of NSCLC diagnosis
  4. Documentation of testing by a CLIA certified lab for genomic drivers of lung cancer
  5. Willingness to undergo all study procedure
  6. Provision of written informed consent

Exclusion criteria

Exclusion Criteria:

  1. Male or female aged less than 18 years; or less than the age of majority for their residential state
  2. Greater than or equal to 50 years of age at the time of NSCLC diagnosis
  3. No documentation of mutation testing
  4. Unwilling to undergo all study procedures
  5. Unable or unwilling to provide consent
05

Study design

Observational model
Case-only
Time perspective
Other
Enrollment
187 participants (actual)
Target follow-up
1 Month
Patient registry
Yes
Biospecimen retention
Samples without dna

Groups and cohorts

  • EGFR

    Other: Online Survey

  • ROS1

    Other: Online Survey

  • ALK

    Other: Online Survey

  • KRAS

    Other: Online Survey

  • NSCLC Other

    Other: Online Survey

Interventions

  • OtherOnline Survey

    Epidemiological Survey (approx 200 questions)

06

What researchers measure

Primary outcomes

  1. Exploratory epidemiology correlates

    Exploratory correlations between all questionnaire variables (demographic factors, medical history, smoking history, early life exposures (child and mother), residential history, occupational history, menstrual and reproductive history, diet, and physical activity.

    Time frame: 1 month

07

Study locations

2 sites
  • USC Keck School of Medicine
    Los Angeles, California 90033, United States
  • Addario Lung Cancer Medical Institute
    San Carlos, California 94070, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 4, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04640259
Lead sponsor
Addario Lung Cancer Medical Institute
Collaborators
University of Southern California, Ohio State University Comprehensive Cancer Center
Responsible party
Sponsor
First posted
Nov 23, 2020
Start date
Feb 1, 2021
Primary completion
Dec 10, 2025
Completion
Mar 6, 2026
Last update
Aug 4, 2026

Study contacts

Jorge Nieva, MD
principal investigator · University of Southern California
Barbara Gitlitz, MD
principal investigator · University of Southern California

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

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