A Phase 2 interventional study of 18F-FDG and [18F]F-PDL1-3 in Lung Cancer (NSCLC), Cervical Squamous Cell Cancer and Melanoma (Skin Cancer), sponsored by Peking University Cancer Hospital & Institute. Recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-29.
Sponsored by Peking University Cancer Hospital & Institute · Phase 2, Interventional, and Diagnostic
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Among 11 studies in Lung Neoplasms by Peking University Cancer Hospital & Institute — 7 open to participants now, 8 under way, none of them phase 3. Lung Neoplasms · Peking University Cancer Hospital & Institute.
Among the 11 studies in Lung Neoplasms by Peking University Cancer Hospital & Institute, this one is one of 3 that started in 2026, is one of 2 in phase 2, and was the 10th registered.
5,423 studies on the registry are indexed under Lung Neoplasms; 1,345 are open to participants now.
Browse Lung Neoplasms studies →7 of the 11 studies in Lung Neoplasms by Peking University Cancer Hospital & Institute are open now, in 1 country. Recruiting first, the newest first:
Peking University Cancer Hospital & Institute · Sites in China
Ages 65+
Peking University Cancer Hospital & Institute · Sites in China
Ages 18+
Peking University Cancer Hospital & Institute · Sites in China
Ages 65+
Peking University Cancer Hospital & Institute · Sites in China
Ages 18–70
Peking University Cancer Hospital & Institute
Ages 18–75
By country, each count listing its studies:
Of the 995 Lung Neoplasms studies recruiting now, 682 (69%) set no upper age limit and 142 (14%) stop at 75 or younger; 45 take children under 18; 142 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
11 studies; the count open now beside each. This study's row is marked.
First in 2017; this study’s year is marked. 3 started in 2026.
This study's planned enrollment of 50 is below the median of 60 across 3,657 interventional studies indexed under Lung Neoplasms.
Median enrollment 50 across the 9 interventional studies, 270 across the 2 observational. Of the 1 that completed or were terminated, 0 (0%) have results posted.
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Peking University Cancer Hospital & Institute is the lead sponsor of 269 studies on the registry; 128 are open to participants now.
5 of the studies in Lung Neoplasms by Peking University Cancer Hospital & Institute that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07442292Peking University Cancer Hospital & InstitutePD-L1 Targeting Peptide Probe for PET Imaging of Solid Tumor | 2026-12 |
| NCT07915193Peking University Cancer Hospital & InstituteApplication of Generative Artificial Intelligence in Perioperative Personalized Rehabilitation for Older Adults With Lung Cancer | 2026-12-31 |
| NCT07589101Peking University Cancer Hospital & Institute5T4 Targeting Nanobody Probe for PET Imaging in Solid Tumors | 2027-06-30 |
| NCT07848243Peking University Cancer Hospital & InstituteClinical Investigator-Initiated Trial (IIT) of PD-L1-Targeted Radionuclide Probes | 2027-07-31 |
| NCT06674252Peking University Cancer Hospital & InstituteA Study on the Improvement of Postoperative Symptoms and Survival Benefits of Modified Bufei Decoction in Elderly Patients With Lung Cancer Undergoing Radical Surgery | 2027-09 |
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Among the 11 studies in Lung Neoplasms by Peking University Cancer Hospital & Institute, from their registry updates:
This tab as a report to print or save as PDF → With an account.
[18F]F-PDL1-3 molecular probe was used to detect the expression of PD-L1 in primary and metastatic tumors of patients with solid tumors. The heterogeneity of PD-L1 expression in the same lesion and different lesions was further evaluated, and the changes of PD-L1 expression in the course of the disease were observed. This method is helpful for the screening of patients with solid tumors with high PD-L1 expression, efficacy monitoring, and early warning of drug resistance and/or recurrence or metastasis, and ultimately achieve individualized targeted therapy of tumors
According to the inclusion and exclusion criteria, 50 patients with solid tumors were selected. The first 5 subjects completed 45 minutes dynamic scan image acquisition, and then static scan was performed at subsequent time points. Each subject completed at least 1 hour and 2 hours of static acquisition, and 3 hours of image acquisition depending on the subject's physical condition and other comprehensive factors). Within 3 months after the subjects completed the examination, the researchers will retrieve the subjects' electronic medical records through the medical record system or telephone interview. The laboratory examination results, pathological results, and other imaging comprehensive diagnosis results of the subjects were collected, and the changes of lesions were observed. The expression level of PD-L1 in traditional tissue biopsy was compared with the results of [18F]F-PDL1-3 PET/CT examination.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
All study participants will be assigned to this group (single-group study). Study participants will undergo \[18F\]F-PDL1-3 PET/CT scans. The injection dose was 1.52-2.72 MBq/kg. Whole-body imaging of the head and trunk will be performed using a United imaging EXPLORER whole-body PET/CT scanner at 1 h, 2 h, and 3 h post-injection after participants have rested quietly for 40 min or 1 h. The scan range was from the apex of the thigh to the upper third of the thigh. Participants requiring dynamic scanning underwent a 40-min serial scan after injection of \[18F\]F-PDL1-3.. PET/CT static imaging was performed at 3h after injection.
Drug: 18F-FDG · Drug: [18F]F-PDL1-3
participants were required to fast for more than 6 hours before examination. The prepared and qualified 18F-FDG 3.7-5.55MBq/kg was injected intravenously into the subjects. After 1 hour of rest, the subjects underwent Whole Body imaging with uEXPLORER whole-body PET/CT from the top of the head to the upper 1/3 of the thigh. Subjects were placed in the supine position and breathed calmly. The collection conditions of head and trunk were the same as above. The data were reconstructed by OSEM to obtain coronal, sagittal, and cross-sectional PET and PET/CT fusion images
participants received intravenous \[18F\]F-PDL1-3 at a quality-control dose (1.52-2.72 MBq/kg). Whole-body imaging of the head and trunk will be performed using the United imaging uEXPLORER whole-body PET/CT scanner at 1 h, 2 h, and 3 h post-injection after the subject has rested quietly for 1 h. The scan range was from the apex of the thigh to the upper third of the thigh. Subjects requiring dynamic scanning underwent a 5-min CT scan prior to \[18F\]F-PDL1-3 injection, followed by 40 min of continuous image acquisition after injection. PET/CT static imaging was performed at 2 h and 3 h after injection. During the scan, the subject will be placed in the supine position and breathe quietly. Acquisition parameters for the head and trunk will be as described above. The data were reconstructed using the OSEM algorithm to generate coronal, sagittal, and transverse axial PET and PET/CT fusion images.
Safety - Tracer-related Adverse Events
Number of participants with tracer-related adverse events.
Time frame: From the start of radiotracer administration through 7 days after injection.
Feasibility of PET/CT Imaging
Number of participants in whom evaluable PET/CT images were successfully acquired at prespecified time points, as independently assessed by two senior nuclear medicine physicians. Images were considered evaluable if they met diagnostic quality criteria.
Time frame: Dynamic PET/CT scanning from 0 to 40 minutes post-injection; static PET/CT scans at 1 hour, 2 hours, and 3 hours post-injection.
Radiochemical Purity
Radiochemical purity of the radiotracer, reported as percentage (%), determined by iTLC. Criterion: ≥95%.
Time frame: 1 h before each injection on each imaging day
Bacterial Endotoxins
Bacterial endotoxin level, reported in EU/mL, determined by photometry. Criterion: ≤15 EU/mL.
Time frame: Before preparation of each drug batch.Once a month.
Standardized Uptake Value (SUV)
Parameters of SUV The maximum standardized uptake value (SUVmax), mean standardized uptake value (SUVmean) and tumor/background ratio (SUVR) of \[68Ga\]Ga-THP-PDL1-3 in target lesions were observed. SUVR was calculated as the SUVmax of the target lesion divided by the SUVmean of the reference normal tissue
Time frame: Quantitative analysis was performed at all imaging time points within two weeks after the end of imaging.
Plan to share: Yes — In accordance with the ICMJE data-sharing guidelines and Chinese data-privacy laws, raw clinical and imaging data were not publicly available to prevent compromise of patient privacy. However, the corresponding author will share deidentified patient-level data, imaging parameters (SUV values), and study protocol details if reasonable requested by the requestor.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form
Time frame: Data access will be granted through a secure data sharing agreement for a period of 5 years after publication.
Access criteria: Applicants must provide a methodologically sound research plan and obtain approval from their institutional ethics committee.
No publications or documents are linked to this record.
Started Feb 2026 (actual). Primary completion is estimated for Jul 2027, 17 months after the start.
Of 287 non-industry phase 2 interventional studies under Lung Neoplasms, half reached primary completion within 72 months of starting (the median), counting those still running; a quarter within 43 and three quarters within 113. This study's planned 17 months is below that.
Counting every sponsor, half of 364 studies reached it within 65 months; a quarter within 34 and three quarters within 105.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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