Lung Cancer (NSCLC)Phase 2NCT07848243
Clinical Investigator-Initiated Trial (IIT) of PD-L1-Targeted Radionuclide Probes
A Phase 2 study testing 18F-FDG and [18F]F-PDL1-3 in people with Lung Cancer (NSCLC) and Cervical Squamous Cell Cancer, run by Peking University Cancer Hospital & Institute at 1 site in China.
Trial summary
[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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer (NSCLC), Cervical Squamous Cell Cancer, Melanoma (Skin Cancer)
- What is being tested?
- 18F-FDG and [18F]F-PDL1-3
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2026to 31 Dec 2027
- Phase
- Phase 2
- 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
Who may be able to join
- Age >18 years old, ECOG score 0 or 1;
- subjects with pathologically confirmed solid tumors (lung cancer, cervical cancer, melanoma, breast cancer, gastrointestinal tumor, etc.), recent recurrence or suspected recurrence of previous solid tumors;
- There was at least one measurable target lesion according to RECIST1.1 criteria;
- Predicted survival time ≥12 weeks;
- Blood routine, liver and kidney function meet the following standards: see the study protocol for specific requirements;
- Women must be using an effective contraceptive method (effective contraception means sterilization, intrauterine hormonal devices, condoms, contraceptives/pills, abstinence, or partner's removal of the vas deferentia) during the study and for 6 months after the study; Men should consent to subjects who must use contraception during the study period and for 6 months after the end of the study period;
- Subjects can fully understand and voluntarily participate in this experiment, and sign an informed consent. Compliance was good.
Who cannot join
- Severe abnormal liver and kidney function.
- Pre-pregnancy, pregnant and lactating women.
- Unable to lie flat for half an hour.
- Refusal to be a clinical investigator.
- Claustrophobia or other mental illness.
- Known allergy to the investigational drug or its excipients in the study treatment; Other circumstances considered by the investigator to be inappropriate for trial participation.
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
Beijing Cancer hospital
Beijing
Hua Zhu, 010-88196495, zhuhuabch@pku.edu.cn
About this study
[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
Read the detailed description
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.
- Conditions
- Lung Cancer (NSCLC), Cervical Squamous Cell Cancer, Melanoma (Skin Cancer), Breast Cancer, Gastrointestinal Cancers
- Being tested
- 18F-FDG, [18F]F-PDL1-3
- Keywords
- Radioactive medicine, De novo design
- Medical subject headings
- Lung Neoplasms, Carcinoma, Non-Small-Cell Lung, Melanoma, Breast Neoplasms, Gastrointestinal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
18F-FDGDrug
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
[18F]F-PDL1-3Drug
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.
| Study group | Role | What they receive |
|---|---|---|
| [18F]F-PDL1-3 | Experimental | 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. Receives: Drug: 18F-FDG; Drug: [18F]F-PDL1-3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety - Tracer-related Adverse Events
Number of participants with tracer-related adverse events.
Measured: 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.
Measured: 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%.
Measured: 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.
Measured: Before preparation of each drug batch.Once a month.
Secondary outcomes (1)
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
Measured: Quantitative analysis was performed at all imaging time points within two weeks after the end of imaging.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2026
- Study start1 Feb 2026
- Primary completion31 Jul 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung Cancer (NSCLC)Studies of the same condition, open and under way.
- More trials run by Peking University Cancer Hospital & InstituteThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Cancer Hospital & Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hua Zhu, Peking University Cancer Hospital & Institute
- Investigators
- Hua Zhu, Principal investigator, Peking University Cancer Hospital & Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07848243
- Sponsor's protocol ID
- 2026KT147
- Status last verified
- Feb 2026
- First submitted
- 18 Sep 2026
- Last updated
- 29 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Investigator-Initiated Trial (IIT) of PD-L1-Targeted Radionuclide Probes
- ClinicalTrials.gov ID
- NCT07848243
- Acronym / sponsor ID
- 2026KT147
- Conditions
- Lung Cancer (NSCLC), Cervical Squamous Cell Cancer, Melanoma (Skin Cancer), Breast Cancer, Gastrointestinal Cancers
- Keywords
- Radioactive medicine, De novo design
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Peking University Cancer Hospital & InstituteUniversity, hospital or other
- Study start
- 1 Feb 2026 (actual)
- Primary completion
- 31 Jul 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 29 Sep 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.
[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
Detailed description
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| [18F]F-PDL1-3 | Experimental | Drug: 18F-FDG, Drug: [18F]F-PDL1-3All 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age >18 years old, ECOG score 0 or 1;
- subjects with pathologically confirmed solid tumors (lung cancer, cervical cancer, melanoma, breast cancer, gastrointestinal tumor, etc.), recent recurrence or suspected recurrence of previous solid tumors;
- There was at least one measurable target lesion according to RECIST1.1 criteria;
- Predicted survival time ≥12 weeks;
- Blood routine, liver and kidney function meet the following standards: see the study protocol for specific requirements;
Key exclusion criteria (6 listed)
- Severe abnormal liver and kidney function.
- Pre-pregnancy, pregnant and lactating women.
- Unable to lie flat for half an hour.
- Refusal to be a clinical investigator.
- Claustrophobia or other mental illness.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 18F-FDGparticipants 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 | Drug | [18F]F-PDL1-3 |
| [18F]F-PDL1-3participants 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. | Drug | [18F]F-PDL1-3 |
Primary outcome
Safety - Tracer-related Adverse Events
Time frame: From the start of radiotracer administration through 7 days after injection.
Number of participants with tracer-related adverse events.
Feasibility of PET/CT Imaging
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.
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.
Radiochemical Purity
Time frame: 1 h before each injection on each imaging day
Radiochemical purity of the radiotracer, reported as percentage (%), determined by iTLC. Criterion: ≥95%.
Bacterial Endotoxins
Time frame: Before preparation of each drug batch.Once a month.
Bacterial endotoxin level, reported in EU/mL, determined by photometry. Criterion: ≤15 EU/mL.
1 secondary outcome
Standardized Uptake Value (SUV)
Time frame: Quantitative analysis was performed at all imaging time points within two weeks after the end of imaging.
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 29 Sep 2026.
- Individual participant dataSharing planned: 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.
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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.
Hua Zhu principal investigator
Peking University Cancer Hospital & Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 18F-FDG and [18F]F-PDL1-3 in people with Lung Cancer (NSCLC) and Cervical Squamous Cell Cancer, run by Peking University Cancer Hospital & Institute 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 6 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 29 Sep 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Hua Zhu (010-88196495, zhuhuabch@pku.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety - Tracer-related Adverse Events (time frame: From the start of radiotracer administration through 7 days after injection.). The study lists 4 primary outcomes in all. 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 29 Sep 2026.