Biology of Young Lung Cancer Study: The YOUNG LUNG Study

The purpose of this research study is to learn more about lung cancer (NSCLC or SCLC) diagnosed in adults at ages 45 or younger.

Study Overview

• Status: Recruiting
• Conditions: Small Cell Lung Carcinoma; Non Small Cell Lung Cancer; NUT Carcinoma
• Intervention / Treatment: Genetic: Data and Specimen Collection

Detailed Description

This research study looks to enroll as many people diagnosed with lung cancer at 45 years old or younger in order to:

• Better understand causes of lung cancer in individuals 45 years old and younger, which is a rare disease
• Better estimate lung cancer risks and potential risk factors for lung cancer in individuals 45 years old and younger
• Examine tumor (somatic) or normal (germline) genetic changes that may be shared among young lung cancer patients
• Improve opportunities for screening and treatment of lung cancer in individuals 45 years old and younger

Study procedures will include:

• Collecting information from participants' medical record and two (2) short questionnaires
• Collecting blood and/or saliva samples
• Collecting tumor tissue samples (optional)

It is expected that about 500 people will take part in this research study. Participants will be in this study until it closes or the participant withdraws consent.

• Study Type: Observational
• Enrollment (Estimated): 500

Contacts and Locations

• Study Contact: Name: Pasi A Janne, MD, PhD; Phone Number: 617-632-6036; Email: Pasi_Janne@dfci.harvard.edu

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Recruiting
      • Massachusetts General Hospital
      • Principal Investigator: Jessica Lin, MD
      • Contact: Jessica Line, MD; Phone Number: 617-724-1134; Email: jjlin1@partners.org
    • Boston, Massachusetts, United States, 02115
      • Not yet recruiting
      • Brigham and Women's Hospital
      • Contact: Pasi A Janne, MD, PhD; Phone Number: 617-632-6036; Email: Pasi_Janne@dfci.harvard.edu
      • Principal Investigator: Pasi A Janne, MD, PhD
    • Boston, Massachusetts, United States, 02115
      • Recruiting
      • Dana-Farber Cancer Institute
      • Contact: Pasi A Janne, MD, PhD; Phone Number: 617-632-6036; Email: Pasi_Janne@dfci.harvard.edu
      • Principal Investigator: Pasi A Janne, MD, PhD
    • Boston, Massachusetts, United States, 02115
      • Not yet recruiting
      • Beth Israel Deaconess Medical Center
      • Contact: Daniel Costa, MD PhD; Phone Number: 617-667-9236
      • Principal Investigator: Daniel Costa, MD PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 45 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Adults age 45 or under at time of non-small lung cancer (NSCLC) or small cell lung cancer (SCLC) diagnosis

Description

Inclusion Criteria:

• Age 45 and under at lung cancer diagnosis
• Pathologically confirmed bronchogenic lung carcinoma (NSCLC or SCLC of any stage) at any treatment time point
• Provision of written informed consent
• Willingness to undergo no more than two (2) peripheral blood draws in a four (4) week period, with no more than 50 ml peripheral blood collected over eight (8) weeks
• Individuals under age 18 are eligible for study if they meet defined criteria; in addition, consent for participation must be given by a legal guardian or parent

Exclusion Criteria:

• Individuals who decline to sign consent
• Individuals who are unable to give consent or assent and are without a designated healthcare proxy
• Compromise of patient diagnosis or staging if tissue is used for research

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Other

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Data/Biospecimen Collection; Tumor and saliva specimens from participants with non-small cell lung cancer (NSCLC) or small cell lung cancer (SCLC) diagnosed at age 45 or younger

Genetic: Data and Specimen Collection; Provide research team access to relevant medical records; Answer two (2) short questionnaires at time of consent; Provide up to 5 tubes (37 ml) of blood at or near the time of consent, and/or saliva sample; Consider consenting to other optional parts of the research such as:Providing additional blood or tissue samples in the future (optional)Providing permission for obtainment of stored tissue specimens from lung cancer surgeries or biopsies from the pathology departments where they have been stored (optional)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Repository of specimens and data	Prospective registry of young lung cancer specimens for exploratory tumor and germline genomics, transcriptomics/proteomics, and future biomarker study.	5 years or study closure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of patients with targetable somatic alterations in known oncogenic driver genes	Targetable alterations are defined as any somatic alteration in a driver oncogene for which a Food and Drug Administration-approved therapy exists, for which an off-label therapy exists, or for which a clinical trial exists (including but not limited to EGFR, KRAS, ALK, ROS1, RET, MET, BRAF, and TRK). Results will be summarized using descriptive statistics.	5 years or study closure
Number of patients with predicted oncogenic alterations in unknown driver genes	Unknown driver genes include genes not currently known to be driver oncogenes in lung cancer, and for which no directed treatment exists. Results will be summarized using descriptive statistics.	5 years or study closure
Number of patients with pathogenic or likely pathogenic germline alterations in known cancer predisposition genes	Pathogenic or likely pathogenic variants based on classification by the American College of Medical Genetics and Genomics (ACMG). Results will be summarized using descriptive statistics.	5 years or study closure

Collaborators and Investigators

• Sponsor: Dana-Farber Cancer Institute
• Investigators: Principal Investigator: Pasi A Janne, MD, PhD, Dana-Farber Cancer Institute

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2023
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): August 1, 2027

Study Registration Dates

• First Submitted: February 16, 2022
• First Submitted That Met QC Criteria: February 22, 2022
• First Posted (Actual): March 3, 2022

Study Record Updates

• Last Update Posted (Estimated): October 29, 2025
• Last Update Submitted That Met QC Criteria: October 28, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Keywords: Genetics; Non Small Cell Lung Cancer; Genomics; Small Cell Lung Carcinoma; Young lung cancer
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Lung Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Carcinoma, Non-Small-Cell Lung; Small Cell Lung Carcinoma; Investigative Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling
• Other Study ID Numbers: 21-442

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing Time Frame: Data can be shared no earlier than 1 year following the date of publication
• IPD Sharing Access Criteria: Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No