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Blood test may predict when lung cancer returns after immunotherapy

NCT ID NCT05198154

Diagnosis Sponsor: Fang Wu 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 31, 2026 · Last updated Sep 01, 2026 · Updated 1 time

Summary

This trial tests whether a blood test that detects circulating tumor DNA (ctDNA) can predict when advanced non-small cell lung cancer might progress in people who have already benefited from first-line immunotherapy for at least 12 months. Researchers will follow 100 participants and compare ctDNA levels with imaging scans to see if the blood test can signal progression earlier. The goal is to improve monitoring and potentially guide treatment decisions.

What this could mean

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

Active substance
ctDNA detection via high-depth sequencing blood test
What this could lead to
If it works, this blood test could help doctors spot cancer progression earlier and adjust treatment sooner for people with advanced lung cancer.
What could go wrong
This is an early, observational study, so the test may not reliably predict progression in all patients. False alarms or missed signals are possible.

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 100 people

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

Started

Jan 2022

Expected to finish

Nov 2029

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

Clinically confirmed advanced NSCLC patients with long-term benefit after first-line immunotherapy

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: * Age ≥ 18 years old * Advanced non-small cell lung cancer (stage IIIB-IV), pathological types limited to squamous cell carcinoma or non-squamous cell carcinoma, driver gene mutations (EGFR/ALK/ROS1) were negative * General condition: ECOG score 0 or 1 * First-line monotherapy or combination immunotherapy * The long-term benefit of immunotherapy was defined as PFS=12months * Tumor tissue samples can be obtained at the time of enrollment, and at least 5 \~ 10 sections can be generated, and the pathological report indicates that the overall tumor content is not less than 10% or NGS testing with a fixed-panel is available; or no tumor tissue is available. * At least one measurable lesion (except patients with CR after first-line treatment) can be evaluated according to RECIST1.1 standard. * Have self-awareness, be able to understand the research scheme and voluntarily participate in the study, and can sign the informed consent form * Have good compliance, be able to cooperate with the collection of specimens from each node and provide corresponding clinical information. Exclusion Criteria: * Serious primary diseases of the heart, liver and kidney * Other malignant tumors within 3 years prior to diagnosis of NSCLC * Women in pregnancy and lactation * The active stage of human immunodeficiency virus (HIV) infection * Patients with active systemic infection, pneumonia, tuberculosis, pericarditis * Patients who cannot understand the content of the experiment and cannot cooperate and refuse to sign informed consent.

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Conditions

The condition(s) this trial relates to.

Neoplasm, Residual non-small cell lung carcinoma

As listed by the trial registrant

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

Advanced lung non-small cell carcinoma

Contacts and locations

Locations

  • Oncology Department，Second Xiangya Hospital of Central South University

    Changsha, Hunan, 410011, China

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