Clinical trial NCT05928299: Integrative Multi-Omics Testing for Immunotherapy Response in Non-Small Cell Lung Cancer
Official title: Proteomic and Metabolomic Features Testing for Immunotherapy Response in Non-Small Cell Lung Cancer
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Lung Cancer
Keywords: Non-Small Cell Lung Cancer
Immunotherapy
Blood Proteomic
Blood Metabolomic
Urine Proteomic
Urine Metabolomic
Monitoring of Immunotherapy Response
Multi-omics
Lead sponsor: Nanfang Hospital, Southern Medical University
Sponsor class: OTHER
First posted: 2023-07-03
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with advanced NSCLC eligible for treatment of immunotherapy.

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.

Eligibility 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);

Primary outcomes:
measure: The expression of blood and urine proteomic markers at baseline
timeFrame: Baseline
measure: The levels of blood and urine metabolites at baseline
timeFrame: Baseline
measure: The expression of blood and urine proteomic markers during immunotherapy
timeFrame: 3 years
measure: The levels of blood and urine metabolites during immunotherapy
timeFrame: 3 years
measure: The expression of blood and urine proteomic markers at progression
timeFrame: 3 years
measure: The levels of blood and urine metabolites at progression
timeFrame: 3 years
Secondary outcomes:
measure: Immune-related adverse events (irAEs)
timeFrame: 3 years
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Nanfang hospital
state: Guangdong
Study officials:
References: