Mapping treatment strategies for radiation and immune checkpoint inhibitor pneumonitis using single-cell sequencing

Single-cell Sequencing of Bronchoalveolar Lavage Fluid to Guide the Treatment of Radiation Pneumonitis or Immune Checkpoint Inhibitor Pneumonitis

This study is testing how single-cell sequencing can help find better treatments for patients with lung inflammation caused by radiation or immune therapies.

Quick facts

• Phase: PHASE1; PHASE2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Xinqiao Hospital of Chongqing (other)
• Drugs / interventions: radiation
• Locations: 1 site (Chongqing, Chongqing Municipality)
• Trial ID: NCT05455034 on ClinicalTrials.gov

What this trial studies

This multicenter exploratory research aims to investigate the pathogenesis and prevention strategies of radiation pneumonitis and immune checkpoint inhibitor pneumonitis through single-cell sequencing of bronchoalveolar lavage fluid. Patients diagnosed with these conditions will receive specific treatments based on established guidelines and the insights gained from the sequencing results. The study seeks to establish a new clinical application of single-cell sequencing technology to improve treatment outcomes for affected patients.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 to 75 with non-small cell lung cancer who have been diagnosed with radiation or immune checkpoint inhibitor pneumonitis and have not received glucocorticoids or other immunosuppressive drugs.

Not a fit: Patients with significant liver or kidney dysfunction, severe infections, or those requiring systemic corticosteroids may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could lead to more personalized and effective treatment strategies for patients suffering from pneumonitis.

How similar studies have performed: While the use of single-cell sequencing in clinical applications is emerging, this specific approach to pneumonitis treatment is relatively novel and has not been extensively tested in prior studies.

Eligibility criteria

Inclusion Criteria:

1. Informed consent has been signed, and according to the judgment of the investigator, the patient can comply with the study protocol and sign the written informed consent;
2. NSCLC patients who have been clinically diagnosed with RP or CIP after histopathologically confirmed radiotherapy or immunocheckpoint inhibitor treatment and have not received glucocorticoid or other drugs.
3. ≥18 years old, less than 75 years old;
4. ECOG PS score 0-3 in the Eastern Tumor Collaboration group;
5. Patients without contraindications to alveolar lavage;

Exclusion Criteria:

1. Poor patient compliance and violation of test regulations;
2. Liver and kidney dysfunction, such as myocardial infarction, angina pectoris, liver transaminase significantly increased;
3. Had any medical condition requiring systemic treatment with corticosteroids or other immunosuppressive drugs within 14 days prior to enrollment;
4. Severe infection occurred within 4 weeks prior to enrollment, including but not limited to hospitalization due to infection complications, bacteremia or severe pneumonia;
5. Severe chronic or active infections (including tuberculosis infection) requiring systemic (oral or intravenous) antibiotic treatment within 14 days prior to enrollment;
6. Untreated patients with chronic hepatitis B, HBV carriers with HBV DNA≥ 500 IU/mL, or patients with active hepatitis C virus (HCV) should be excluded. Note: Non-active hepatitis B, surface antigen (HBsAg) carriers, treated and stable hepatitis B carriers (HBV DNA \& LT; 500 IU/mL), patients with cured hepatitis C could be enrolled;
7. Known history of HIV infection;
8. Received any other investigational drug or participated in any other clinical trial within 28 days.

Where this trial is running

Chongqing, Chongqing Municipality

• Xinqiao Hospital — Chongqing, Chongqing Municipality, China (RECRUITING)

Study contacts

• Principal investigator: Jianguo Sun, doctor — Xinqiao Hospital
• Study coordinator: Jianguo Sun, doctor

Conditions: Pneumonitis, Single-cell Sequencing, Radiation Pneumonitis, Immune Checkpoint Inhibitor Pneumonitis, Bronchoalveolar Lavage Fluid