Clinical trial · Observational
Integrative Multi-Omics Testing for Immunotherapy Response in Non-Small Cell Lung Cancer
Proteomic and Metabolomic Features Testing for Immunotherapy Response in Non-Small Cell Lung Cancer
NCT05928299CI-TRIAL-00112229IMOTIONcompletedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The objective of this study is to use blood and urine proteomic and metabolomic features to monitor lung cancer immunotherapy response.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (2)
- label
- Durable Clinical Benefit
- description
- PFS≥ 6 months
- label
- Non-durable Clinical Benefit
- description
- PFS\< 6 months
Primary outcomes (6)
- measure
- The expression of blood and urine proteomic markers at baseline
- timeFrame
- Baseline
- description
- 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.
- measure
- The levels of blood and urine metabolites at baseline
- timeFrame
- Baseline
- description
- 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
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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);
References
Publications (0)
Data not yet available
No reference posted for this study.