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

Nanfang Hospital, Southern Medical University

Status: Enrolling

Conditions: Lung Cancer

Study type: Observational

Funder types: Other

Identifiers

NCT05928299

NFEC-2023-128

Details and patient eligibility

About

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

Full 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.

Enrollment: 400 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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);

Trial design

400 participants in 2 patient groups

Durable Clinical Benefit

Description:

PFS≥ 6 months

Non-durable Clinical Benefit

Description:

PFS\< 6 months