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Blood markers may reveal which lung cancer patients stay Cancer-Free after treatment

NCT ID NCT05415358

Knowledge-focused Sponsor: Wake Forest University Health Sciences Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study follows 23 people with advanced non-small cell lung cancer who have finished at least 20 months of immunotherapy. Researchers collect blood and tissue samples to look for DNA and immune system markers that might predict if the cancer will come back within 6 months. The goal is to find better ways to monitor patients after treatment ends.

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 help doctors know which lung cancer patients are at risk of their cancer returning after stopping immunotherapy, leading to better follow-up care.
What could go wrong
This is a small, early-stage study with only 23 participants. It is observational, so it won't test a new treatment. The results may not apply to all 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 23 people

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

Started

Jan 2023

Expected to finish

Sep 2035

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

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

Who is studied

Patients with metastatic non-small cell lung carcinoma who have completed first line immune checkpoint inhibitor monotherapy or immune checkpoint inhibitor platinum doublet combination therapy, and have, at immunotherapy discontinuation, completed at least 20 of an anticipated 24 months of immune checkpoint inhibitor treatment. These treatments are managed according to standard of care.

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.

Inclusion Criteria 1. Informed consent and HIPAA authorization for release of personal health information signed by the subject. Note: Data from tumor samples, blood samples and radiographic scans prior to enrollment date may be used. 2. Age greater than or equal to18 years at the time of consent. 3. Patients with metastatic non-small cell lung carcinoma have completed first line who, at immunotherapy discontinuation, have completed at least 20 of an anticipated 24 months of immune checkpoint inhibitor monotherapy or pembrolizumab combination chemotherapy in the first line setting. 4. Patients are allowed to continue maintenance chemotherapy. 5. Ability to understand and comply with study procedures for the entire length of the study. 6. Known PD-L1 prior to initiation of first-line treatment for NSCLC. Exclusion Criteria 1. Enrollment/collection of baseline sample earlier than 7 days prior to scheduled last dose of immune checkpoint inhibitor treatment or more than 30 days after last dose of immune checkpoint inhibitor treatment. 2. Patients whose tumors harbor known first line treatment druggable gene abnormalities (e.g. EGFR, BRAF, ALK, ROS1). 3. Patients who have ever received or are currently receiving other types of immunotherapies (nivolumab, ipilimumab, durvalumab or atezolizumab). 4. Known pregnancy. 5. Patients who progress per the enrolling investigator while on treatment with immune checkpoint inhibitor treatment prior to enrollment.

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Conditions

The condition(s) this trial relates to.

non-small cell lung carcinoma

As listed by the trial registrant

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

Lung cancer, nonsmall cell

Contacts and locations

Locations

  • Atrium Health Levine Cancer

    Charlotte, North Carolina, 28204, United States

  • Atrium Health Wake Forest Baptist Comprehensive Cancer Center

    Winston-Salem, North Carolina, 27157, United States

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