NMR blood test to detect checkpoint inhibitor–related pneumonitis in people with lung cancer

Prospective Study of NMR-based Serum Metabolic Profiles for the Diagnosis of Checkpoint Inhibitor-related Pneumonitis

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
• Enrollment: 60 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Guangzhou Institute of Respiratory Disease (other)
• Drugs / interventions: immunotherapy
• Locations: 1 site (Guangzhou, Guangdong)
• Trial ID: NCT07340892 on ClinicalTrials.gov

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.

Who should consider this trial

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.

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.

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 performed: 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.

Eligibility 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 this trial is running

Guangzhou, Guangdong

• The First Affiliated Hospital of Guangzhou Medical University — Guangzhou, Guangdong, China (RECRUITING)

Study contacts

• Study coordinator: Chengzhi Zhou, MD

Conditions: Checkpoint Inhibitor-related Pneumonitis, Checkpoint inhibitor-related pneumonitis, ¹H-nuclear magnetic resonance, Metabolism