Checkpoint Inhibitor-related PneumonitisNCT07340892
Diagnostic Biomarkers for Checkpoint Inhibitor-related Pneumonitis
An observational study of Checkpoint Inhibitor-related Pneumonitis, run by Zhou Chengzhi at 1 site in China.
Trial summary
Checkpoint inhibitor-related pneumonitis (CIP) is a common fatal immune-related adverse events of PD-1/PD-L1 inhibitors. Early diagnosis of CIP is crucial for timely intervention and improved prognosis; however, the absence of precise and effective diagnostic techniques often leads to underdiagnosis and misdiagnosis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Checkpoint Inhibitor-related Pneumonitis
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 10 Jan 2026to 10 Jan 2028
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Prospective, dual-cohort, biomarker discovery study
Who may be able to join
- Patients with a pathological diagnosis of lung cancer;
- The subject has received at least one course of immune checkpoint inhibitor treatment;
- Capable of understanding and voluntarily signing an informed consent form.
- For the CIP group, the following additional criteria must be met:
- 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:
- Has had no clinical symptoms or radiographic evidence suggestive of pneumonitis at enrollment or prior to enrollment.
Who cannot join
- Pulmonary lesions were definitively diagnosed as tumor progression, bacterial pneumonia, or pulmonary edema;
- Incomplete or missing follow-up data.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, 510100
Chengzhi Zhou, 81567329, doctorzcz@163.com
About this study
Official title: Prospective Study of NMR-based Serum Metabolic Profiles for the Diagnosis of Checkpoint Inhibitor-related Pneumonitis
Checkpoint inhibitor-related pneumonitis (CIP) is a common fatal immune-related adverse events of PD-1/PD-L1 inhibitors. Early diagnosis of CIP is crucial for timely intervention and improved prognosis; however, the absence of precise and effective diagnostic techniques often leads to underdiagnosis and misdiagnosis. The investigators conducted a prospective clinical study to evaluate the effectiveness of ¹H-nuclear magnetic resonance (NMR)-based lipoprotein and metabolite analysis in diagnosing checkpoint inhibitor-related pneumonitis (CIP), aiming to improve its early diagnosis rate.
Read the detailed description
Checkpoint inhibitor-related pneumonitis (CIP) is a common and potentially fatal immune-related adverse event associated with PD-1/PD-L1 inhibitor therapy. The early and accurate diagnosis of CIP is crucial for timely intervention and improving patient prognosis. However, in clinical practice, the overlapping clinical presentations and imaging features of CIP with infectious pneumonia, tumor progression, or other pulmonary diseases pose a significant diagnostic challenge. The current lack of precise and specific diagnostic techniques often leads to underdiagnosis or misdiagnosis. This diagnostic dilemma can delay the optimal treatment window and may result in the unnecessary interruption or discontinuation of effective immunotherapy, ultimately compromising overall anti-tumor efficacy.
Metabolomics, the comprehensive analysis of small-molecule metabolites, provides a dynamic readout of an organism's physiological state and has shown great promise in biomarker discovery for various diseases. Serum, in particular, offers an easily accessible biofluid that reflects systemic metabolic alterations. ¹H-Nuclear Magnetic Resonance (¹H-NMR) spectroscopy is a robust, reproducible, and quantitative platform ideal for profiling key serum components, including lipoproteins and a wide range of low-molecular-weight metabolites, in a high-throughput manner. The investigators hypothesize that the development of CIP induces a distinct, detectable alteration in the host's systemic metabolic profile, which can be captured by NMR analysis and serve as a diagnostic signature.
- Conditions
- Checkpoint Inhibitor-related Pneumonitis
- Keywords
- Checkpoint inhibitor-related pneumonitis, ¹H-nuclear magnetic resonance, Metabolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Checkpoint inhibitor-related pneumonitis | |
| Control group | Lung cancer patients who received immunotherapy but did not develop CIP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic performance
The Area Under the Receiver Operating Characteristic Curve (AUROC) of a classifier model derived from NMR serum metabolic profiles to distinguish between patients with confirmed checkpoint inhibitor-related pneumonitis and control patients on immunotherapy without pneumonitis.
Measured: Blood sampling for testing within 1 day after enrollment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2026
- Study start10 Jan 2026 (estimated)
- Primary completion10 Jan 2027 (estimated)
- Study completion10 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Checkpoint Inhibitor-related PneumonitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Zhou Chengzhi
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Zhou Chengzhi, Guangzhou Institute of Respiratory Disease
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07340892
- Sponsor's protocol ID
- CROC202601
- Status last verified
- Jan 2026
- First submitted
- 5 Jan 2026
- Last updated
- 4 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Study of NMR-based Serum Metabolic Profiles for the Diagnosis of Checkpoint Inhibitor-related Pneumonitis
- ClinicalTrials.gov ID
- NCT07340892
- Acronym / sponsor ID
- CROC202601
- Conditions
- Checkpoint Inhibitor-related Pneumonitis
- Keywords
- Checkpoint inhibitor-related pneumonitis, ¹H-nuclear magnetic resonance, Metabolism
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Zhou ChengzhiUniversity, hospital or other
- Study start
- 10 Jan 2026 (estimated)
- Primary completion
- 10 Jan 2027 (estimated)
- Study completion
- 10 Jan 2028 (estimated)
- First posted
- 14 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Checkpoint inhibitor-related pneumonitis (CIP) is a common fatal immune-related adverse events of PD-1/PD-L1 inhibitors. Early diagnosis of CIP is crucial for timely intervention and improved prognosis; however, the absence of precise and effective diagnostic techniques often leads to underdiagnosis and misdiagnosis. The investigators conducted a prospective clinical study to evaluate the effectiveness of ¹H-nuclear magnetic resonance (NMR)-based lipoprotein and metabolite analysis in diagnosing checkpoint inhibitor-related pneumonitis (CIP), aiming to improve its early diagnosis rate.
Detailed description
Checkpoint inhibitor-related pneumonitis (CIP) is a common and potentially fatal immune-related adverse event associated with PD-1/PD-L1 inhibitor therapy. The early and accurate diagnosis of CIP is crucial for timely intervention and improving patient prognosis. However, in clinical practice, the overlapping clinical presentations and imaging features of CIP with infectious pneumonia, tumor progression, or other pulmonary diseases pose a significant diagnostic challenge. The current lack of precise and specific diagnostic techniques often leads to underdiagnosis or misdiagnosis. This diagnostic dilemma can delay the optimal treatment window and may result in the unnecessary interruption or discontinuation of effective immunotherapy, ultimately compromising overall anti-tumor efficacy.
Metabolomics, the comprehensive analysis of small-molecule metabolites, provides a dynamic readout of an organism's physiological state and has shown great promise in biomarker discovery for various diseases. Serum, in particular, offers an easily accessible biofluid that reflects systemic metabolic alterations. ¹H-Nuclear Magnetic Resonance (¹H-NMR) spectroscopy is a robust, reproducible, and quantitative platform ideal for profiling key serum components, including lipoproteins and a wide range of low-molecular-weight metabolites, in a high-throughput manner. The investigators hypothesize that the development of CIP induces a distinct, detectable alteration in the host's systemic metabolic profile, which can be captured by NMR analysis and serve as a diagnostic signature.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | – | –Checkpoint inhibitor-related pneumonitis |
| Control group | – | –Lung cancer patients who received immunotherapy but did not develop CIP |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Prospective, dual-cohort, biomarker discovery study
Key inclusion criteria (7 listed)
- Patients with a pathological diagnosis of lung cancer;
- The subject has received at least one course of immune checkpoint inhibitor treatment;
- Capable of understanding and voluntarily signing an informed consent form.
- Highly suspected of having checkpoint inhibitor pneumonitis based on radiological abnormalities and/or pulmonary symptoms (including fever, cough, and dyspnea).
- Has had no clinical symptoms or radiographic evidence suggestive of pneumonitis at enrollment or prior to enrollment.
Key exclusion criteria (2 listed)
- Pulmonary lesions were definitively diagnosed as tumor progression, bacterial pneumonia, or pulmonary edema;
- Incomplete or missing follow-up data.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Diagnostic performance
Time frame: Blood sampling for testing within 1 day after enrollment.
The Area Under the Receiver Operating Characteristic Curve (AUROC) of a classifier model derived from NMR serum metabolic profiles to distinguish between patients with confirmed checkpoint inhibitor-related pneumonitis and control patients on immunotherapy without pneumonitis.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Checkpoint Inhibitor-related Pneumonitis, run by Zhou Chengzhi at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chengzhi Zhou, MD (81567329, doctorzcz@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic performance (time frame: Blood sampling for testing within 1 day after enrollment.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2026.