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

Enrichment of Lung Cancer Screening Through Unexplained Weight Loss (UWL) to Stage Shift and Improve Survival

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.

Study Overview

• Status: Recruiting
• Conditions: Lung Cancer Screening
• Intervention / Treatment: Diagnostic test: Low Dose CT imaging; Other: blood draws; Other: screening questionnaire

• Study Type: Observational
• Enrollment (Estimated): 409

Contacts and Locations

• Study Contact: Name: Amy Xu, MD, PhD; Phone Number: 646-888-6863; Email: xua@mskcc.org
• Study Contact Backup: Name: Bernard Park, MD; Phone Number: 646-888-3346

Study Locations

• United States
  • New Jersey
    • Basking Ridge, New Jersey, United States, 07920
      • Recruiting
      • Memorial Sloan Kettering at Basking Ridge (All Protocol Activities)
      • Contact: Amy Xu, MD, PhD; Phone Number: 646-888-6863
    • Middletown, New Jersey, United States, 07748
      • Recruiting
      • Memorial Sloan Kettering Monmouth (All Protocol Activities)
      • Contact: Amy Xu, MD, PhD; Phone Number: 646-888-6863
    • Montvale, New Jersey, United States, 07645
      • Recruiting
      • Memorial Sloan Kettering Bergen (All Protocol Activities)
      • Contact: Amy Xu, MD, PhD; Phone Number: 646-888-6863
  • New York
    • Commack, New York, United States, 11725
      • Recruiting
      • Memorial Sloan Kettering Suffolk-Commack (All Protocol Activities)
      • Contact: Amy Xu, MD, PhD; Phone Number: 646-888-6863
    • East White Plains, New York, United States, 10604
      • Recruiting
      • Memorial Sloan Kettering Westchester (All Protocol Activities)
      • Contact: Amy Xu, MD, PhD; Phone Number: 646-888-6863
    • New York, New York, United States, 10065
      • Recruiting
      • Memorial Sloan Kettering Cancer Center (All Protocol Activities)
      • Contact: Amy Xu, MD, PhD; Phone Number: 646-888-6863
    • The Bronx, New York, United States, 10467
      • Recruiting
      • Montefiore Health Systems (Montefiore Medical Center)
      • Contact: Neel Chudgar, MD; Phone Number: (718) 920-8874
    • Uniondale, New York, United States, 11553
      • Recruiting
      • Memorial Sloan Kettering Nassau (All Protocol Activities)
      • Contact: Amy Xu, MD, PhD; Phone Number: 646-888-6863

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Potential research subjects will be identified at MSKCC largely through survivorship clinics.

Description

Inclusion Criteria:

• Eligible for American Cancer Society lung cancer screening, as follows as per the discretion of the screening team:

  • 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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Diagnostic test: Low Dose CT imaging; at baseline and at Year 1.; Other: blood draws; at baseline and at Year 1.; Other: screening questionnaire; at baseline and at 1 year after registration.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The incidence of lung cancer in patients with unexplained weight loss	Low Dose CT screening	2 years

Collaborators and Investigators

• Sponsor: Memorial Sloan Kettering Cancer Center
• Collaborators: AstraZeneca
• Investigators: Principal Investigator: Amy Xu, MD, PhD, Memorial Sloan Kettering Cancer Center

Publications and helpful links

Helpful Links

• Memorial Sloan Kettering Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): December 2, 2024
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: December 3, 2024
• First Submitted That Met QC Criteria: December 3, 2024
• First Posted (Actual): December 5, 2024

Study Record Updates

• Last Update Posted (Actual): September 4, 2026
• Last Update Submitted That Met QC Criteria: September 3, 2026
• Last Verified: September 1, 2026

More Information

Terms related to this study

• Keywords: ctDNA analysis; Low dose computed tomography (CT)
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Body Weight; Respiratory Tract Diseases; Body Weight Changes; Lung Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Weight Loss; Lung Neoplasms; Investigative Techniques; Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Blood Specimen Collection
• Other Study ID Numbers: 24-302

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No