Using multi-omics to assess immunotherapy response in lung cancer
Proteomic and Metabolomic Features Testing for Immunotherapy Response in Non-Small Cell Lung Cancer
This study is testing how well immunotherapy works for people with non-small cell lung cancer by looking at blood and urine samples to see if certain markers can predict their response to treatment.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 400 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Nanfang Hospital, Southern Medical University Academic / other |
| Drugs / interventions | immunotherapy |
| Locations | 1 site (Guangzhou, Guangdong) |
| Trial ID | NCT05928299 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the effectiveness of immunotherapy in patients with non-small cell lung cancer (NSCLC) by analyzing blood and urine samples for proteomic and metabolomic features. It will include a total of 400 patients, with 200 being retrospectively analyzed from past immunotherapy treatments and 200 prospectively enrolled for ongoing treatments. The study will monitor how these biological markers correlate with patient responses to immunotherapy over time.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with advanced or metastatic non-small cell lung cancer who are eligible for immunotherapy.
Not a fit: Patients with a history of autoimmune diseases or those with specific genetic mutations that contraindicate immunotherapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved monitoring and personalized treatment strategies for patients undergoing immunotherapy for lung cancer.
How similar studies have performed: While similar approaches using multi-omics in cancer treatment have shown promise, this specific application in NSCLC immunotherapy response is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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);
Where this trial is running
Guangzhou, Guangdong
- Nanfang hospital — Guangzhou, Guangdong, China (Recruiting)
Study contacts
- Study coordinator: Laiyu Liu, Doctor of Medicine
- Email: liulaiyu@sina.com
- Phone: +86 13632102245
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.