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

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

NCT ID: NCT05928299

Condition: Lung Cancer

Conditions: Official terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung

Conditions: Keywords:
Non-Small Cell Lung Cancer
Immunotherapy
Blood Proteomic
Blood Metabolomic
Urine Proteomic
Urine Metabolomic
Monitoring of Immunotherapy Response
Multi-omics

Study type: Observational

Overall status: Recruiting

Study design:

Time perspective: Other

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

Detailed description: Observational, ambispective single-center cohort study, including 400 patients with locally advanced unresectable or metastatic NSCLC who received or are receiving immunotherapy in routinely clinical practice. For the part of retrospective study，the investigators intend to include 200 patients who received immunotherapy at Nanfang Hospital from January 1, 2020 to March 1, 2023. For the part of prospective study，the investigators intend to include 200 patients who will receive immunotherapy at Nanfang Hospital from March 1, 2023 to December 31, 2025.

Criteria for eligibility:

Study pop:
Patients with advanced NSCLC eligible for treatment of immunotherapy.

Sampling method: Non-Probability Sample
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);

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Nanfang hospital

Address:
City: Guangzhou
Zip: 510400
Country: China

Status: Recruiting

Start date: January 1, 2020

Completion date: December 31, 2025

Lead sponsor:
Agency: Nanfang Hospital, Southern Medical University
Agency class: Other

Source: Nanfang Hospital, Southern Medical University

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05928299