Non Small Cell Lung CancerNCT05265429
Biology of Young Lung Cancer Study: The YOUNG LUNG Study
An observational study of Non Small Cell Lung Cancer and Small Cell Lung Carcinoma, run by Dana-Farber Cancer Institute at 4 sites in United States.
Trial summary
The purpose of this research study is to learn more about lung cancer (NSCLC or SCLC) diagnosed in adults at ages 45 or younger. Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- Non Small Cell Lung Cancer, Small Cell Lung Carcinoma, NUT Carcinoma
- What is being tested?
- Data and Specimen Collection
- How many people
- 500 participants
- Where
- 4 sitesUnited States
- Study dates
- 1 Jan 2023to 1 Aug 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Adults age 45 or under at time of non-small lung cancer (NSCLC) or small cell lung cancer (SCLC) diagnosis
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States4 sites, 4 recruiting
- Recruiting
Massachusetts General Hospital
Boston, Massachusetts, 02114
Jessica Line, MD, 617-724-1134, jjlin1@partners.org
Jessica Lin, MD
- Not yet recruiting
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02115
Daniel Costa, MD PhD, 617-667-9236
Daniel Costa, MD PhD
- Not yet recruiting
Brigham and Women's Hospital
Boston, Massachusetts, 02115
Pasi A Janne, MD, PhD, 617-632-6036, Pasi_Janne@dfci.harvard.edu
Pasi A Janne, MD, PhD
- Recruiting
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115
Pasi A Janne, MD, PhD, 617-632-6036, Pasi_Janne@dfci.harvard.edu
Pasi A Janne, MD, PhD
About this 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.
Read the 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.
- Being tested
- Data and Specimen Collection
- Keywords
- Non Small Cell Lung Cancer, Small Cell Lung Carcinoma, Genetics, Genomics, Young lung cancer
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Small Cell Lung Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Data and Specimen CollectionGenetic
- 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)
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Genetic: Data and Specimen Collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Repository of specimens and data
Prospective registry of young lung cancer specimens for exploratory tumor and germline genomics, transcriptomics/proteomics, and future biomarker study.
Measured: 5 years or study closure
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: 5 years or study closure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2022
- Study start1 Jan 2023
- Primary completion1 Aug 2027 (estimated)
- Study completion1 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non Small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Dana-Farber Cancer InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dana-Farber Cancer Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jaclyn LoPiccolo, MD, Dana-Farber Cancer Institute
- Investigators
- Pasi A Janne, MD, PhD, Principal investigator, Dana-Farber Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05265429
- Sponsor's protocol ID
- 21-442
- Status last verified
- Oct 2025
- First submitted
- 16 Feb 2022
- Last updated
- 19 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biology of Young Lung Cancer Study: The YOUNG LUNG Study
- ClinicalTrials.gov ID
- NCT05265429
- Acronym / sponsor ID
- 21-442
- Keywords
- Non Small Cell Lung Cancer, Small Cell Lung Carcinoma, Genetics, Genomics, Young lung cancer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Dana-Farber Cancer InstituteUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 1 Aug 2027 (estimated)
- Study completion
- 1 Aug 2027 (estimated)
- First posted
- 3 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this research study is to learn more about lung cancer (NSCLC or SCLC) diagnosed in adults at ages 45 or younger.
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 design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Data/Biospecimen Collection | – | Genetic: Data and Specimen CollectionTumor and saliva specimens from participants with non-small cell lung cancer (NSCLC) or small cell lung cancer (SCLC) diagnosed at age 45 or younger |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Adults age 45 or under at time of non-small lung cancer (NSCLC) or small cell lung cancer (SCLC) diagnosis
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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) | Genetic | Data/Biospecimen Collection |
Primary outcome
Repository of specimens and data
Time frame: 5 years or study closure
Prospective registry of young lung cancer specimens for exploratory tumor and germline genomics, transcriptomics/proteomics, and future biomarker study.
3 secondary outcomes
Number of patients with targetable somatic alterations in known oncogenic driver genes
Time frame: 5 years or study closure
Number of patients with predicted oncogenic alterations in unknown driver genes
Time frame: 5 years or study closure
Number of patients with pathogenic or likely pathogenic germline alterations in known cancer predisposition genes
Time frame: 5 years or study closure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2026.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Pasi A Janne, MD, PhD principal investigator
Dana-Farber Cancer Institute
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non Small Cell Lung Cancer and Small Cell Lung Carcinoma, run by Dana-Farber Cancer Institute at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jaclyn LoPiccolo, MD, PhD (857-215-8041, Jaclyn_LoPiccolo@dfci.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Repository of specimens and data (time frame: 5 years or study closure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2026.