CompletedNot Applicable

Integrative Multi-Omics Testing for Immunotherapy Response in Non-Small Cell Lung Cancer

China150 participantsStarted 2020-01-01

Plain-language summary

The objective of this study is to use blood and urine proteomic and metabolomic features to monitor lung cancer immunotherapy response.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Patients who are 18 years or older at the time of signing the informed consent form;
. 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);
. 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);
. Patients with at least one measurable lesion according to the Response Evaluation Criteria in Solid Tumors \[RECIST\], version 1.1;
. 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;
. Patients who signed the informed consent and are willing to participate in the study.

Exclusion criteria

. Patients with the history of autoimmune disease or immunodeficiency disease;
. 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;

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

The expression of blood and urine proteomic markers at baseline

Timeframe: Baseline

The levels of blood and urine metabolites at baseline

Timeframe: Baseline

The expression of blood and urine proteomic markers during immunotherapy

Timeframe: 3 years

The levels of blood and urine metabolites during immunotherapy

Timeframe: 3 years

The expression of blood and urine proteomic markers at progression

Timeframe: 3 years

The levels of blood and urine metabolites at progression

Timeframe: 3 years

Trial details

NCT IDNCT05928299

SponsorNanfang Hospital, Southern Medical University

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2025-12-31

View on ClinicalTrials.gov More Lung Cancer trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Patients who are 18 years or older at the time of signing the informed consent form;
. 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);
. 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);
. Patients with at least one measurable lesion according to the Response Evaluation Criteria in Solid Tumors \[RECIST\], version 1.1;
. 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;
. Patients who signed the informed consent and are willing to participate in the study.

Exclusion criteria

. Patients with the history of autoimmune disease or immunodeficiency disease;
. 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;

What they're measuring

The expression of blood and urine proteomic markers at baseline

Timeframe: Baseline

The levels of blood and urine metabolites at baseline

Timeframe: Baseline

The expression of blood and urine proteomic markers during immunotherapy

Timeframe: 3 years

The levels of blood and urine metabolites during immunotherapy

Timeframe: 3 years

The expression of blood and urine proteomic markers at progression

Timeframe: 3 years

The levels of blood and urine metabolites at progression

Timeframe: 3 years