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Blood tests could predict lung cancer return

NCT ID NCT05236114

Knowledge-focused Sponsor: Tempus AI Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study is collecting blood samples and health information from 1200 people with non-small cell lung cancer. Researchers want to understand how the cancer changes over time and whether simple blood tests can predict if the cancer will come back. Participants continue their normal treatment and provide blood samples during regular checkups.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this could lead to better ways to predict lung cancer recurrence and treatment outcomes using simple blood tests.
What could go wrong
This is an observational study, not a treatment trial, so it won't directly help participants. The findings may not apply to all lung cancer patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 1,200 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2022

Expected to finish

Jun 2029

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

This protocol targets patients with Non-Small Cell Lung Cancer (NSCLC)

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

For Cohort 1 Inclusion, the participant has/is: * A known or suspected NSCLC treated with curative intent -(surgery with or without perioperative (neoadjuvant or adjuvant) therapy). * Suspected NSCLC - Patients with a high index of suspicion for the diagnosis of NSCLC that is resectable may sign informed consent prior to undergoing diagnostic procedure at the discretion of the physician. NCCN Guidelines allow for clinical stage IA cancers to proceed directly to definitive surgery. Per NCCN Guidelines, if a preoperative tissue diagnosis has not been obtained, then an intraoperative diagnosis will be obtained. If a diagnosis of NSCLC is not confirmed and/or the tumor is not resectable, then the patient will be a screen failure. * Undergone or planning to undergo a surgical resection - (Patients with stages I-IIIB who are resectable - per NCCN guidelines of resectability) * Both patients who lack molecular abnormalities and those with identified molecular abnormalities may enroll. Choice of perioperative therapy is to follow SOC therapeutic guidelines for the participant's molecular and PD-L1 profile. * 18 years old or older * Willing and able to provide informed consent * Willing to have additional blood samples collected during routine surveillance visits * Must submit tumor sample representative of current disease For Cohort 1 Exclusion, the participant has/is: * Patients with superior sulcus tumors who are candidates for preoperative concurrent chemoradiation. * Stage III locally advanced and unresectable patients who are candidates for chemoradiation followed by immunotherapy. * It is expected that all patients on the cohort will be treated with a definitive surgical resection. Thus, clinical stage IIIB and IIIC patients who subsequently demonstrate pathologically confirmed N3 nodal disease or T4 N2 or 3 per any confirmatory procedure listed in NCCN guidelines for which definitive chemoradiotherapy rather than surgery is recommended per NCCN Guidelines are not eligible. * Patients who receive primary radiation (in lieu of surgery if they are not surgical candidates). For Cohort 2 Inclusion, the participant has/is: * Histologically documented Stage IV NSCLC (de novo metastatic or relapse setting) not amenable to curative surgery or radiation therapy. Palliative radiation (for instance for impending bony fracture or to control pain) is allowed at any time during the protocol at the physician's discretion. * Intended to receive first line immunotherapy (as monotherapy or in combination with chemotherapy). Patients who have had previous exposure to immunotherapy in the neoadjuvant or adjuvant setting are allowed to enroll as long as 12 months have elapsed since the prior exposure. * Patients in surveillance on Cohort 1 are eligible to roll over to Cohort 2 at the time of recurrence as long as they have had histologic confirmation of recurrence and have been off immunotherapy for 12 months or greater and meet all other inclusion/exclusion criteria. * Tumors that lack activating EGFR mutations (e.g., exon 19 deletion or exon 21 L858R, exon 21 L861Q, exon 18 G719X, or exon 20 S768I mutation) and ALK fusions. Also, per NCCN Guideline recommended testing, tumors must also lack ROS1, BRAF, NTRK 1/2/3, METex14 skipping mutations, and RET for which there is available front-line targeted therapy. Only those patients with KRAS G12C mutations and ERBB2 (HER2) mutations with no contraindications to immunotherapy (PD-L1 1) for which there are no approved front-line targeted therapies and for whom immunotherapy would be the preferred front-line therapy are eligible. * Patients may be enrolled with local molecular testing and those results will be provided. * Patients may be enrolled with local molecular testing and those results will be provided. * 18 years and older * Willing and able to provide informed consent * Willing to have additional blood samples collected during routine surveillance visits * Must submit tumor sample representative of current disease Exclusion Criteria (both Cohorts): * Patients without a known or suspected NSCLC diagnosis, or other disease processes such as sarcoidosis, lymphoma, or metastatic cancer from other sites. * Not willing to have additional blood samples collected * Patients with a secondary malignancy must have been both diagnosed \> 2 years from the lung cancer of interest and have completed all therapy for that malignancy (including extended adjuvant therapy) \> 2 years prior to diagnosis of the lung cancer of interest with the exception of the following: * Patients with superficial basal cell carcinoma of low-risk histology per NCCN Guidelines (Low-risk histologic subtypes include nodular, superficial, and other non-aggressive growth patterns such as keratotic, infundibulocystic, and fibroepithelioma of Pinkus) and low-risk for recurrence per NCCN Guidelines (location on trunk or extremities, size \< 2 cm, primary (not recurrent), with well-defined borders) can be included even if they are diagnosed \< 2 years from the lung cancer of interest. * Patients with superficial squamous cell carcinoma of low-risk pathology per NCCN Guidelines (verrucous, keratoacanthomatous) and low-risk for recurrence per NCCN Guidelines (located on trunk or extremities; 2 cm in size; primary lesion (vs. recurrent); well to moderately differentiated; \< 2 mm thick and no invasion beyond subcutaneous fat; negative for perineural invasion; and negative for lymphatic or vascular involvement) can be included even if they are diagnosed \< 2 years from the lung cancer of interest.

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Conditions

The condition(s) this trial relates to.

neoplasm non-small cell lung carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Non-small cell lung cancer

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    56 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Alabama Oncology

    RECRUITING

    Birmingham, Alabama, 35223, United States

  • Aultman Hospital

    RECRUITING

    Canton, Ohio, 44710, United States

  • Baptist Cancer Center

    RECRUITING

    Memphis, Tennessee, 38120, United States

  • Cancer Care Associates of York

    RECRUITING

    York, Pennsylvania, 17403, United States

  • Cancer Care Northwest

    RECRUITING

    Spokane Valley, Washington, 99216, United States

  • Cancer Care Specialists Reno

    RECRUITING

    Reno, Nevada, 89511, United States

  • Cancer Care Specialists of Illinois

    RECRUITING

    Decatur, Illinois, 62526, United States

  • Cancer and Blood Specialty Clinic

    ACTIVE_NOT_RECRUITING

    Los Alamitos, California, 90720, United States

  • Cayuga Medical Center

    RECRUITING

    Ithaca, New York, 14850, United States

  • Clermont Oncology Center

    RECRUITING

    Clermont, Florida, 34711, United States

  • Community Health Network

    RECRUITING

    Indianapolis, Indiana, 46250, United States

  • Duke University

    RECRUITING

    Durham, North Carolina, 27710, United States

  • Eastern CT and Hematology and Oncology Associates

    RECRUITING

    Norwich, Connecticut, 06360, United States

  • Frederick Health Regional System

    RECRUITING

    Frederick, Maryland, 21702, United States

  • Gundersen Health System

    RECRUITING

    La Crosse, Wisconsin, 54601, United States

  • Hawaii Cancer Care

    RECRUITING

    Honolulu, Hawaii, 96813, United States

  • Hematology Oncology Associates of Central New York

    RECRUITING

    East Syracuse, New York, 13057, United States

  • Hightower Clinical

    RECRUITING

    Oklahoma City, Oklahoma, 73102, United States

  • Hope Cancer Care of Nevada

    RECRUITING

    Las Vegas, Nevada, 89103, United States

  • Hope and Healing Cancer Services

    RECRUITING

    Hinsdale, Illinois, 60521, United States

  • Icahn School of Medicine at Mount Sinai

    RECRUITING

    New York, New York, 10029, United States

  • Johns Hopkins University

    RECRUITING

    Baltimore, Maryland, 21287, United States

  • Lake Regional Health System

    RECRUITING

    Osage Beach, Missouri, 65065, United States

  • MemorialCare

    RECRUITING

    Fountain Valley, California, 92708, United States

  • Mercy Clinic Cancer and Hematology - Chub O'Reilly Cancer Center

    RECRUITING

    Springfield, Missouri, 65804, United States

  • Mercy Clinic Oncology - Fort Smith

    RECRUITING

    Fort Smith, Arkansas, 72903, United States

  • Mercy Clinic Oncology and Hematology - Coletta

    RECRUITING

    Oklahoma City, Oklahoma, 73120, United States

  • Mercy Clinic Oncology and Hematology - David C. Pratt Cancer Center

    RECRUITING

    St Louis, Missouri, 63141, United States

  • Mercy Clinic Oncology and Hematology - Joplin

    RECRUITING

    Joplin, Missouri, 64804, United States

  • Mercy Clinic Oncology and Hematology - Sindelar Cancer Center

    RECRUITING

    St Louis, Missouri, 63128, United States

  • Morehouse School of Medicine (MSM)

    RECRUITING

    Atlanta, Georgia, 30310, United States

  • Nebraska Cancer Specialists

    RECRUITING

    Omaha, Nebraska, 68130, United States

  • New Jersey Cancer Center

    RECRUITING

    Belleville, New Jersey, 07109, United States

  • New York Oncology Hematology

    RECRUITING

    Albany, New York, 12206, United States

  • Northwestern University

    RECRUITING

    Evanston, Illinois, 60208, United States

  • OSF Saint Anthony Medical Center

    RECRUITING

    Rockford, Illinois, 61108, United States

  • Ohio State University

    RECRUITING

    Columbus, Ohio, 43210, United States

  • OhioHealth Reseach Institute

    RECRUITING

    Columbus, Ohio, 43214, United States

  • Oklahoma Cancer Specialists and Research Institute

    RECRUITING

    Tulsa, Oklahoma, 74146, United States

  • Oncology Hematology Associates

    RECRUITING

    Springfield, Missouri, 65807, United States

  • OptumCare Cancer Care

    RECRUITING

    Las Vegas, Nevada, 89102, United States

  • Oregon Oncology Specialists

    RECRUITING

    Salem, Oregon, 97301, United States

  • PeaceHealth St. Joseph Medical Center-Bellingham

    RECRUITING

    Bellingham, Washington, 98225, United States

  • Piedmont Healthcare

    RECRUITING

    Atlanta, Georgia, 30318, United States

  • Southeastern Medical Oncology Center (SMOC)

    RECRUITING

    Goldsboro, North Carolina, 27534, United States

  • Southern Illinois Hospital Services

    RECRUITING

    Carterville, Illinois, 62918, United States

  • Taylor Cancer Research Center

    RECRUITING

    Maumee, Ohio, 43537, United States

  • The Center for Cancer and Blood Disorder

    RECRUITING

    Bethesda, Maryland, 20817, United States

  • The Medical University of South Carolina

    RECRUITING

    Charleston, South Carolina, 29425, United States

  • ThedaCare Regional Cancer Center

    RECRUITING

    Appleton, Wisconsin, 54911, United States

  • TriHealth Cancer Institute

    RECRUITING

    Cincinnati, Ohio, 45220, United States

  • UCLA

    RECRUITING

    Los Angeles, California, 90095, United States

  • UNC

    RECRUITING

    Chapel Hill, North Carolina, 27599, United States

  • University of Iowa

    RECRUITING

    Iowa City, Iowa, 52242, United States

  • University of Maryland

    RECRUITING

    Baltimore, Maryland, 21201, United States

  • University of Virginia

    RECRUITING

    Charlottesville, Virginia, 22908, United States

  • White Plains Hospital

    RECRUITING

    White Plains, New York, 10601, United States

  • Woodlands Medical Specialists

    WITHDRAWN

    Pensacola, Florida, 32503, United States

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