Lung Cancer (NSCLC)NCT07442292
PD-L1 Targeting Peptide Probe for PET Imaging of Solid Tumor
An observational study of Lung Cancer (NSCLC) and Lung Cancer (SCLC), run by Peking University Cancer Hospital & Institute.
Trial summary
The objective of this study is to construct a noninvasive approach using radiolabbled peptide 68Ga-cPP-BCH PET/CT to detect the PD-L1 expression of tumor lesion in patients with lung cancer, melanoma and other solid tumor to identify patients benefiting from anti-PD-(L)1 treatment. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Lung Cancer (NSCLC), Lung Cancer (SCLC), Melanoma (Skin Cancer)
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Feb 2026to Jun 2027
- Phase
- Observational
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients with lung cancer, melanoma or other solid tumors scheduled for immunotherapy or combined immunotherapy; underwent PD-L1 IHC examination before therapy
Who may be able to join
- Aged 18-75, male and female, with ECOG score of 0 or 1;
- Subjects with lung cancer, melanoma, or other solid tumors scheduled for immunotherapy or combined immunotherapy;
- underwent PD-L1 IHC examination before therapy;
- The expected survival was more than 26 weeks;
- Blood routine test, liver and kidney function meet the following standards: blood routine: WBC >= 4.0 x 10^9/L or neutrophil >= 1.5 x 10^9/:, PLT >= 100 x 10^9 / L, Hb >= 90g / L; Pt or APTT <= 1.5 upper limit of normal value; liver and kidney function: total bilirubin <= 1.5 x ULT (upper limit of normal value), ALT / AST <= 2.5 upper limit of normal value or <= 5 x ULT (subject with liver metastasis), ALP <= 2.5 upper limit of normal value (if bone metastasis or liver metastasis exists, ALP <= 4.5 upper limit of normal value); BUN <= 1.5 x ULT, SCR <= 1.5 x ULT;
- According to RECIST1.1, there was at least one measurable target lesion;
- Understand and sign informed consent voluntarily with good compliance.
Who cannot join
- The function of liver and kidney was seriously abnormal;
- Preparation for pregnant, pregnant and lactating women;
- Inability to lie flat for half an hour;
- Suffering from claustrophobia or other mental disorders;
- Other researchers considered it unsuitable to participate in the trial.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: PD-L1 Targeting Peptide Probe 68Ga-cPP-BCH for PET Imaging of Solid Tumor
The objective of this study is to construct a noninvasive approach using radiolabbled peptide 68Ga-cPP-BCH PET/CT to detect the PD-L1 expression of tumor lesion in patients with lung cancer, melanoma and other solid tumor to identify patients benefiting from anti-PD-(L)1 treatment.
- Conditions
- Lung Cancer (NSCLC), Lung Cancer (SCLC), Melanoma (Skin Cancer), Melanoma Metastatic, PD-L1, PET / CT
- Medical subject headings
- Lung Neoplasms, Carcinoma, Non-Small-Cell Lung, Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients take 68Ga-cPP-BCH PET/CT before and after therapy | Patients take paired baseline 18F-FDG PET/CT and 68Ga-cPP-BCH PET/CT within 1 week; and take 68Ga-cPP-BCH PET/CT after therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
MPR
major pathological response, in the surgical pathology after neo-adjuvant immunotherapy, the proportion of active tumors was less than 10%.
Measured: 3-6 months
Secondary outcomes (1)
ORR
Overall Response Rate
Measured: 3-6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2026
- Study startFeb 2026 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionJun 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07442292
- Sponsor's protocol ID
- 2026KT10
- Status last verified
- Mar 2026
- First submitted
- 24 Feb 2026
- Last updated
- 5 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PD-L1 Targeting Peptide Probe 68Ga-cPP-BCH for PET Imaging of Solid Tumor
- ClinicalTrials.gov ID
- NCT07442292
- Acronym / sponsor ID
- 2026KT10
- Conditions
- Lung Cancer (NSCLC), Lung Cancer (SCLC), Melanoma (Skin Cancer), Melanoma Metastatic, PD-L1, PET / CT
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Peking University Cancer Hospital & InstituteUniversity, hospital or other
- Study start
- Feb 2026 (estimated)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 2 Mar 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.
The objective of this study is to construct a noninvasive approach using radiolabbled peptide 68Ga-cPP-BCH PET/CT to detect the PD-L1 expression of tumor lesion in patients with lung cancer, melanoma and other solid tumor to identify patients benefiting from anti-PD-(L)1 treatment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients take 68Ga-cPP-BCH PET/CT before and after therapy | – | –Patients take paired baseline 18F-FDG PET/CT and 68Ga-cPP-BCH PET/CT within 1 week; and take 68Ga-cPP-BCH PET/CT after therapy |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with lung cancer, melanoma or other solid tumors scheduled for immunotherapy or combined immunotherapy; underwent PD-L1 IHC examination before therapy
Key inclusion criteria (7 listed)
- Aged 18-75, male and female, with ECOG score of 0 or 1;
- Subjects with lung cancer, melanoma, or other solid tumors scheduled for immunotherapy or combined immunotherapy;
- underwent PD-L1 IHC examination before therapy;
- The expected survival was more than 26 weeks;
- Blood routine test, liver and kidney function meet the following standards: blood routine: WBC >= 4.0 x 10^9/L or neutrophil >= 1.5 x 10^9/:, PLT >= 100 x 10^9 / L, Hb >= 90g / L; Pt or APTT <= 1.5 upper limit of normal value; liver and kidney function: total bilirubin <= 1.5 x ULT (upper limit of normal value), ALT / AST <= 2.5 upper limit of normal value or <= 5 x ULT (subject with liver metastasis), ALP <= 2.5 upper limit of normal value (if bone metastasis or liver metastasis exists, ALP <= 4.5 upper limit of normal value); BUN <= 1.5 x ULT, SCR <= 1.5 x ULT;
Key exclusion criteria (5 listed)
- The function of liver and kidney was seriously abnormal;
- Preparation for pregnant, pregnant and lactating women;
- Inability to lie flat for half an hour;
- Suffering from claustrophobia or other mental disorders;
- Other researchers considered it unsuitable to participate in the trial.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
MPR
Time frame: 3-6 months
major pathological response, in the surgical pathology after neo-adjuvant immunotherapy, the proportion of active tumors was less than 10%.
1 secondary outcome
ORR
Time frame: 3-6 months
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 5 Mar 2026.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Cancer (NSCLC) and Lung Cancer (SCLC), run by Peking University Cancer Hospital & Institute.
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 5 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: opening soon, as of the sponsor's last update on 5 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
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.
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, Professor (+86-010-88196495, zhuhuabch@pku.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MPR (time frame: 3-6 months). 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 5 Mar 2026.