NCT07442292

Brief 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.

Trial Health

65
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
12mo left

Started Feb 2026

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress28%
Feb 2026Jun 2027

Study Start

First participant enrolled

February 1, 2026

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

February 24, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 2, 2026

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2027

Last Updated

March 5, 2026

Status Verified

March 1, 2026

Enrollment Period

10 months

First QC Date

February 24, 2026

Last Update Submit

March 3, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • MPR

    major pathological response, in the surgical pathology after neo-adjuvant immunotherapy, the proportion of active tumors was less than 10%.

    3-6 months

Secondary Outcomes (1)

  • ORR

    3-6 months

Study Arms (1)

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

Eligibility Criteria

Age18 Years - 75 Years
Sexall(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients with lung cancer, melanoma or other solid tumors scheduled for immunotherapy or combined immunotherapy; underwent PD-L1 IHC examination before therapy

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Lung NeoplasmsCarcinoma, Non-Small-Cell LungMelanoma

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract DiseasesCarcinoma, BronchogenicBronchial NeoplasmsNeuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasms, Nerve TissueNevi and MelanomasSkin NeoplasmsSkin DiseasesSkin and Connective Tissue Diseases

Central Study Contacts

Hua Zhu, Professor

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

February 24, 2026

First Posted

March 2, 2026

Study Start

February 1, 2026

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

June 1, 2027

Last Updated

March 5, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share