Imaging PD-L1 in Lung Cancer Patients Receiving Immunotherapy
PD-L1 PET Imaging in Patients With the Immunotherapy for Non-small Cell Lung Cancer
This study is testing a new imaging method to see how a protein called PD-L1 behaves in patients with advanced lung cancer who are about to start immunotherapy, hoping to improve treatment choices and results.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Tongji Hospital Academic / other |
| Locations | 1 site (Wuhan, Hubei) |
| Trial ID | NCT05533086 on ClinicalTrials.gov |
What this trial studies
This observational study aims to utilize PD-L1 PET imaging to assess PD-L1 expression in patients with stage IV non-small cell lung cancer (NSCLC) who are planned for anti-PD-1/PD-L1 therapy. The study seeks to overcome the limitations of traditional immunohistochemistry by providing a non-invasive, multidimensional visualization of PD-L1 expression across primary and metastatic tumors. By monitoring PD-L1 expression dynamically during treatment, the study hopes to improve patient selection for immunotherapy and enhance treatment outcomes. The approach could lead to better understanding of PD-L1 heterogeneity and its impact on therapy response.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years old with histologically confirmed stage IV NSCLC who are planned for anti-PD-1/PD-L1 therapy.
Not a fit: Patients who are pregnant, have severe psychiatric or organ insufficiencies, or those who refuse anti-PD-1/PD-L1 therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more effective patient selection for immunotherapy, potentially improving treatment outcomes and reducing unnecessary side effects.
How similar studies have performed: While the use of PD-L1 PET imaging is a novel approach, similar studies have shown promise in improving patient selection and monitoring in cancer therapies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * (1) Subjects must be diagnosed with histologically confirmed stage IV non-small cell lung cancer and \>18 years of age with driver mutations (-). (2) Planned for anti-PD-1/PD-L1 therapy. (3) At least one easy accessible lesion of which a biopsy can be taken within one month prior to PET scan. (4) Subjects must sign informed consent prior to inclusion in this trial. Exclusion Criteria: - (1) Female patients during pregnancy and lactation. (2) Patients with psychiatric disease, severe hepatic and renal insufficiency. (3) Patients who refuse anti-PD-1/PD-L1 therapy. (4) Patients who are claustrophobic or unable to undergo PET/CT examination. (5) Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2 antibody, or any other antibody or drug specifically targeting T-cell costimulation or immune checkpoint pathways, except anti-CTLA4 antibody. (6) Those who, in the opinion of the investigator, are otherwise unsuitable for clinical trials.
Where this trial is running
Wuhan, Hubei
- TongjiHospital — Wuhan, Hubei, China (Recruiting)
Study contacts
- Principal investigator: Zhu Xiaohua, Dr — Tongji Hospital
- Study coordinator: Zhu Xiaohua, Dr
- Email: evazhu@vip.sina.com
- Phone: 13971513770
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.