Single-cell Sequencing of BLF to Guide the Treatment of Radiation Pneumonitis or Immune Checkpoint Inhibitor Pneumonitis

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

Single-cell Sequencing of BLF to Guide the Treatment of Radiation Pneumonitis or Immune Checkpoint Inhibitor Pneumonitis (NCT05455034) is a Phase 1 / Phase 2 interventional studying Pneumonitis, sponsored by Xinqiao Hospital of Chongqing. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

About This Trial

A multicenter, exploratory clinical research, to map the radiation or immune checkpoint inhibitor pneumonitis in patients with alveolar lavage single-celled map. Find out the pathogenesis and prevention strategies of radiation or immune checkpoint inhibitor pneumonitis. Specific treatment is given based on the recommendation of the treatment guidelines for radiation or immune checkpoint inhibitor pneumonitis and the results of single cell sequencing, which will become a new technology for clinical application.

What Stage of Research Is This?

Phase 1 trials test a new treatment for the first time in humans, focusing on safety, dosing, and how the body processes the drug. For Pneumonitis, a Phase 1 study typically enrolls a small number of participants — often healthy volunteers or patients who have exhausted standard treatment options. Phase 1 results determine whether a treatment moves into larger Phase 2 efficacy studies.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

With a target enrollment of 40 participants, this is a small study — typical of early-phase research, rare-disease trials, or pilot studies designed to generate preliminary signal before a larger study is launched.

Who May Be Eligible (Plain English)

Who May Qualify: 1. willing to sign a consent form has been signed, and according to the judgment of the investigator, the patient can comply with the study protocol and sign the written willing to sign a consent form; 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; Who Should NOT Join This Trial: 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. Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language

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.

Treatments Being Tested

GENETIC

single-cell sequencing

Treatment is given according to the results of single-cell sequencing.

Locations (1)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Xinqiao Hospital

Chongqing, Chongqing Municipality, China

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT05455034), the sponsor (Xinqiao Hospital of Chongqing), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT05455034 clinical trial studying?

Who can participate in NCT05455034?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT05455034?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT05455034. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT05455034. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-06-07 · Data from ClinicalTrials.gov.