A Study of Lung Cancer Screening in People With Unexplained Weight Loss

NCT ID: NCT06717334

Last Updated: 2026-01-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

409 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-12-02

Study Completion Date

2026-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The researchers are doing this study to see if people with unexplained weight loss who have lung cancer screening are more likely to have or develop lung cancer than people without unexplained weight loss. The lung cancer screening will involve use of low-dose computed tomography (LDCT), a CT scan that gives off very low doses of radiation and can make detailed pictures of the lungs to help find tumors. The study researchers will also analyze participants' blood samples to determine if blood testing can be used to help to diagnose lung cancer.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Lung Cancer Screening

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Patients undergoing Lung cancer screening

All patients will undergo prospective LDCT imaging annually. At baseline and Year 1, patients will also undergo biospecimen collection for post-hoc ctDNA analysis.

Low Dose CT imaging

Intervention Type DIAGNOSTIC_TEST

at baseline and at Year 1.

blood draws

Intervention Type OTHER

at baseline and at Year 1.

screening questionnaire

Intervention Type OTHER

at baseline and at 1 year after registration.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Low Dose CT imaging

at baseline and at Year 1.

Intervention Type DIAGNOSTIC_TEST

blood draws

at baseline and at Year 1.

Intervention Type OTHER

screening questionnaire

at baseline and at 1 year after registration.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Eligible for American Cancer Society lung cancer screening, as follows:

* Age 50-80 years old
* At least 20-pack year history of smoking
* Weight loss of 3-10%, defined as UWL, within any timeframe over the past in the 18 months prior to enrollment, that cannot be attributed to an underlying medical condition at the discretion of the enrolling investigator

* Note that patients who have 3-10% weight may still be enrolled if the enrolling investigator does not conclude that the weight loss can be attributed to the patient's intentional efforts.
* Documented weight loss can be self-reported or extracted from weights obtained during physician visits. However, if self-reported weight loss is contradicted by weight loss documented in the medical record (e.g. a patients states that (s)he lost 10 lbs in the past 6 months, but a weight documented in the medical record does not support that history), the measured and quantified weight change will be used to ascertain eligibility
* Life expectancy greater than 1 year, per assessment of the treating clinician.

Exclusion Criteria

* Currently pregnant or trying to become pregnant via self-report
* Prior history of recent CT scan of the chest either through LDCT screening or with a scan of the chest (standard, not LDCT) performed within the past 12 months
* Prior history of NSCLC

○ Note that patients with a history of diagnosis of non-lung cancers are eligible for the study.
* Currently undergoing or referred for diagnostic evaluation due to clinical suspicion for malignancy (e.g., referred to a medical or surgical oncologist, or scheduled for biopsy on the basis of a suspicious imaging abnormality).
* Patients with a germline pathogenic genetic variant who have undergone whole body MRI within the past 12 months
* Unable to comply with study procedures
Minimum Eligible Age

50 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

AstraZeneca

INDUSTRY

Sponsor Role collaborator

Memorial Sloan Kettering Cancer Center

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Puneeth Iyengar, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Memorial Sloan Kettering Cancer Center

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Memorial Sloan Kettering at Basking Ridge (All Protocol Activities)

Basking Ridge, New Jersey, United States

Site Status RECRUITING

Memorial Sloan Kettering Monmouth (All Protocol Activities)

Middletown, New Jersey, United States

Site Status RECRUITING

Memorial Sloan Kettering Bergen (All Protocol Activities)

Montvale, New Jersey, United States

Site Status RECRUITING

Memorial Sloan Kettering Suffolk-Commack (All Protocol Activities)

Commack, New York, United States

Site Status RECRUITING

Memorial Sloan Kettering Westchester (All Protocol Activities)

Harrison, New York, United States

Site Status RECRUITING

Memorial Sloan Kettering Cancer Center (All Protocol Activities)

New York, New York, United States

Site Status RECRUITING

Montefiore Health Systems (Montefiore Medical Center)

The Bronx, New York, United States

Site Status RECRUITING

Memorial Sloan Kettering Nassau (All Protocol Activities)

Uniondale, New York, United States

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

United States

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Puneeth Iyengar, MD, PhD

Role: CONTACT

212-639-5159

Bernard Park, MD

Role: CONTACT

646-888-3346

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Puneeth Iyengar, MD, PhD

Role: primary

212-639-5159

Puneeth Iyengar, MD, PhD

Role: primary

212-639-5159

Puneeth Iyengar, MD, PhD

Role: primary

212-639-5159

Puneeth Iyengar, MD, PhD

Role: primary

212-639-5159

Puneeth Iyengar, MD, PhD

Role: primary

212-639-5159

Puneeth Iyengar, MD, PhD

Role: primary

212-639-5159

Neel Chudgar, MD

Role: primary

718-920-8874

Puneeth Iyengar, MD, PhD

Role: primary

212-639-5159

Related Links

Access external resources that provide additional context or updates about the study.

http://www.mskcc.org/mskcc/html/44.cfm

Memorial Sloan Kettering Cancer Center

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

24-302

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Lung Screening Study
NCT00006382 COMPLETED NA
Early Detection of Lung Cancer
NCT03181256 ACTIVE_NOT_RECRUITING
Nashville Early Diagnosis Lung Cancer Project
NCT01475500 ACTIVE_NOT_RECRUITING