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

NCT05928299 | Completed

• 1 other identifier: NFEC-2023-128
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Lung Cancer

Keywords

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

Outcome Measures

Primary Outcomes (6)

• The expression of blood and urine proteomic markers at 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.

  Baseline

• The levels of blood and urine metabolites at 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

  Baseline

• The expression of blood and urine proteomic markers during immunotherapy

  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.

  3 years

• The levels of blood and urine metabolites during immunotherapy

  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

  3 years

• The expression of blood and urine proteomic markers at progression

  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.

  3 years

• The levels of blood and urine metabolites at progression

  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

  3 years

Secondary Outcomes (1)

• Immune-related adverse events (irAEs)

  3 years

Study Arms (2)

Durable Clinical Benefit

PFS≥ 6 months

Non-durable Clinical Benefit

PFS\< 6 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with advanced NSCLC eligible for treatment of immunotherapy.

You may qualify if:

• 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.

You may not qualify if:

• 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;
• Any severe, uncontrolled urological diseases, or urine total protein \>1.0g/day.
• Any severe, uncontrolled metabolic diseases, including uncontrolled diabetes mellitus (fasting blood glucose (FBG)\>10mmol/L);

Sponsors & Collaborators

• Nanfang Hospital, Southern Medical University: lead

Study Sites (1)

Nanfang hospital

Guangzhou, Guangdong, 510400, China

Location

MeSH Terms

Conditions

Lung Neoplasms; Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 8, 2023
• First Posted: July 3, 2023
• Study Start: January 1, 2020
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: May 20, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)