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Simple urine test could show if lung cancer immunotherapy is working

NCT ID NCT05928299

Knowledge-focused Sponsor: Nanfang Hospital, Southern Medical University 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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This completed study looked at 150 people with advanced non-small cell lung cancer to see if proteins and metabolites in blood and urine could help monitor how well immunotherapy is working. Researchers used mass spectrometry to measure these markers before, during, and after treatment. The goal was to find patterns that might predict treatment response or side effects, not to test a new drug.

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 a simple blood or urine test to help doctors know if immunotherapy is working for lung cancer patients.
What could go wrong
This was a small, completed study that only looked for markers—it did not test a new treatment. The findings may not lead to a widely usable test.

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

150 people

The number who actually took part.

Started

Jan 2020

Finished

Dec 2025

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 advanced NSCLC eligible for treatment of 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: 1. Patients who are 18 years or older at the time of signing the informed consent form; 2. Patients with histologically or cytologically confirmed non-small cell lung cancer that is metastatic or locally advanced unresectable, not eligible for local curative treatment (Stage IIIB or IV according to AJCC); 3. Patients without contraindications for immunotherapy according to CSCO guidelines for Non-Small Cell Lung Cancer (NSCLC) version 2022（No EGFR mutations, ALK or ROS1 rearrangement); 4. Patients with at least one measurable lesion according to the Response Evaluation Criteria in Solid Tumors \[RECIST\], version 1.1; 5. Patients who have not received systemic treatment in the past, or who have previously received (neo) adjuvant treatment/radical treatment programs and have relapsed for more than 6 months; 6. Patients who signed the informed consent and are willing to participate in the study. Exclusion Criteria: 1. Patients with the history of autoimmune disease or immunodeficiency disease; 2. Any severe, uncontrolled diseases, including: (1) Active or uncontrolled heart diseases, (2) Renal failure requires hemodialysis or peritoneal dialysis; (3) Liver diseases such as liver cirrhosis, decompensated liver disease, chronic active hepatitis; 3. Any severe, uncontrolled urological diseases, or urine total protein \>1.0g/day. 4. Any severe, uncontrolled metabolic diseases, including uncontrolled diabetes mellitus (fasting blood glucose (FBG)\>10mmol/L);

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Conditions

The condition(s) this trial relates to.

lung cancer lung neoplasm non-small cell lung carcinoma

As listed by the trial registrant

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

Lung cancer

Contacts and locations

Locations

  • Nanfang hospital

    Guangzhou, Guangdong, 510400, China

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