NMR blood test to detect checkpoint inhibitor–related pneumonitis in people with lung cancer
Official title: Prospective Study of NMR-based Serum Metabolic Profiles for the Diagnosis of Checkpoint Inhibitor-related Pneumonitis
Run by Guangzhou Institute of Respiratory Disease · NCT07340892 · Data updated 2026-11-12
This project will test whether a blood 1H‑NMR lipoprotein and metabolite profile can help detect pneumonitis caused by immune checkpoint drugs earlier in people with lung cancer.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 60 (estimated) |
| Sponsor | Guangzhou Institute of Respiratory Disease Academic / other |
| Drugs / interventions | immunotherapy |
| Locations | 1 site (Guangzhou, Guangdong) |
| Status | Recruiting |
| Started | January 10, 2026 |
| Main results expected | January 10, 2027 |
| Study ends | January 10, 2028 |
| Registry record updated | February 4, 2026 |
| Trial ID | NCT07340892 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults with a pathological diagnosis of lung cancer who have received at least one dose of an immune checkpoint inhibitor and can provide informed consent, including those with new radiologic or respiratory symptoms suspected for CIP or matched controls without pneumonitis.
✕Probably not a fit
Patients without lung cancer, those whose lung findings are definitively explained by tumor progression, bacterial pneumonia, or pulmonary edema, or those lacking adequate follow‑up data are unlikely to benefit from this diagnostic approach in this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a prospective observational study enrolling lung cancer patients who have received at least one course of PD‑1/PD‑L1 inhibitor therapy and comparing those with suspected checkpoint inhibitor‑related pneumonitis (CIP) to controls without pneumonitis. Researchers will collect serum and use 1H‑NMR spectroscopy to profile lipoproteins and small‑molecule metabolites, searching for patterns that distinguish CIP from other causes of lung symptoms. The approach leverages a reproducible, high‑throughput metabolomics platform to try to find systemic metabolic signatures associated with CIP. The study is conducted at The First Affiliated Hospital of Guangzhou Medical University and aims to improve early diagnostic accuracy without changing patient treatment as part of standard care.
Why it matters
Potential benefit: If successful, this approach could enable earlier, more accurate detection of CIP so clinicians can start appropriate treatment sooner and avoid unnecessary immunotherapy interruption.
How similar studies have gone: Metabolomics and NMR have identified useful biomarkers in other inflammatory and immune conditions, but NMR‑based serum signatures for checkpoint inhibitor pneumonitis are novel and not yet clinically validated.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Patients with a pathological diagnosis of lung cancer; 2. The subject has received at least one course of immune checkpoint inhibitor treatment; 3. Capable of understanding and voluntarily signing an informed consent form. For the CIP group, the following additional criteria must be met: 4. Highly suspected of having checkpoint inhibitor pneumonitis based on radiological abnormalities and/or pulmonary symptoms (including fever, cough, and dyspnea). For the Control group, the following additional criteria must be met: 5. Has had no clinical symptoms or radiographic evidence suggestive of pneumonitis at enrollment or prior to enrollment. Exclusion Criteria: 1. Pulmonary lesions were definitively diagnosed as tumor progression, bacterial pneumonia, or pulmonary edema; 2. Incomplete or missing follow-up data.
Where it's running
-
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China Recruiting
Study contacts
- Study coordinator: Chengzhi Zhou, MD
- Email: doctorzcz@163.com
- Phone: 81567329
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
PD-L1 Inhibitor Rechallenge After Pneumonitis in Lung Cancer
This study looks at how safe and helpful restarting PD-L1 or PD-1 inhibitors is for adults with lung cancer who previously had immune checkpoint inhibitor–related pneumonitis.
-
AI-powered ECG tools to detect deadly heart rhythms and ICI-related myocarditis
Researchers are testing AI-powered analysis of ECG data to see if it can help flag dangerous arrhythmias and myocarditis in people who may be affected by immune checkpoint inhibitors.
-
Global Cardio Oncology Registry
This study is collecting health information from cancer patients around the world to see what factors might increase their risk of heart problems caused by cancer treatments.
-
Joint tissue analysis to understand rare and immunotherapy-related inflammatory arthritis
This project tests whether analyzing joint biopsy tissue can reveal distinct immune features in adults with inflammatory arthritis linked to rare autoimmune diseases or caused by cancer immunotherapy.
-
Early vedolizumab as first-line treatment for immune-related colitis
We will test whether giving vedolizumab with a short steroid course helps adults with immune checkpoint inhibitor–related colitis recover by 8 weeks better than the usual steroid approach.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.