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

Recruiting

• Conditions: Lung Cancer

• Registration Number: NCT05928299
• Lead Sponsor: Nanfang Hospital, Southern Medical University

Brief 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.

Study Timeline

• Study Start: 2020-01-01
• Study First Submitted: 2023-05-08
• Status Verified: 2023-06
• Study First Submitted QC: 2023-06-29
• Last Update Submitted: 2023-06-29
• Study First Posted: 2023-07-03
• Last Update Posted: 2023-07-03
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 400

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);

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The levels of blood and urine metabolites at baseline	Baseline	Blood and urine metabolites detected by mass spectrometry and nuclear magnetic resonance at baseline. Metabolites identified by the metabolic assay will include but will not be limited to methionine, lactic acid and LDL-C
The expression of blood and urine proteomic markers during immunotherapy	3 years	Blood and urine proteins detected by nanoparticle-based mass spectrometry during immunotherapy. Proteins identified by the proteomic assay will include but will not be limited to KRAS, CCL5, CXCL12 and ANGPTL6.
The levels of blood and urine metabolites during immunotherapy	3 years	Blood and urine metabolites detected by mass spectrometry and nuclear magnetic resonance during immunotherapy. Metabolites identified by the metabolic assay will include but will not be limited to methionine, lactic acid and LDL-C
The expression of blood and urine proteomic markers at progression	3 years	Blood and urine proteins detected by nanoparticle-based mass spectrometry at progression. Proteins identified by the proteomic assay will include but will not be limited to KRAS, CCL5, CXCL12 and ANGPTL6.
The levels of blood and urine metabolites at progression	3 years	Blood and urine metabolites detected by mass spectrometry and nuclear magnetic resonance at progression. Metabolites identified by the metabolic assay will include but will not be limited to methionine, lactic acid and LDL-C
The expression of blood and urine proteomic markers at baseline	Baseline	Blood and urine proteins detected by nanoparticle-based mass spectrometry at baseline. Proteins identified by the proteomic assay will include but will not be limited to KRAS, CCL5, CXCL12 and ANGPTL6.

Secondary Outcome Measures

Name	Time	Method
Immune-related adverse events (irAEs)	3 years	Immune-related adverse events (irAEs), as assessed by Common Terminology Criteria for Adverse Events (CTCAE - Version 5.0)

Trial Locations

Locations (1)

Nanfang hospital; 🇨🇳 Guangzhou, Guangdong, China