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

Lung Cancer Clinical Trial

— IMOTION  

Official title:

Proteomic and Metabolomic Features Testing for Immunotherapy Response in Non-Small Cell Lung Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05928299
• Other study ID #: NFEC-2023-128
• Status: Recruiting
• Start date: January 1, 2020
• Est. completion date: December 31, 2025

Study information

• Verified date: June 2023
• Source: Nanfang Hospital, Southern Medical University
• Contact: Laiyu Liu, Doctor of Medicine
• Phone: +86 13632102245
• Email: liulaiyu[@]sina.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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);

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Cancer
• Lung Neoplasms

Locations

Country	Name	City	State
China	Nanfang hospital	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Nanfang Hospital, Southern Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	Immune-related adverse events (irAEs)	Immune-related adverse events (irAEs), as assessed by Common Terminology Criteria for Adverse Events (CTCAE - Version 5.0)	3 years