PD-L1 PET Imaging in Patients With the Immunotherapy for Non-small Cell Lung Cancer

NCT ID: NCT05533086

Last Updated: 2023-02-13

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 20 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-08-16
• Study Completion Date: 2025-08-31

Brief Summary

Clinical trials have shown efficacy of PD1/PD-L1 checkpoint inhibitors in multiple solid tumors, including NSCLC. Whole body information with regard to target presence, drug kinetics and dynamics, as well as binding of PD-L1 targeting agents to the immune system cells is lacking.Molecular imaging of PD-L1 could lead to new insights on heterogeneity of PD-L1 expression in metastatic lesions and be of help in the prediction of response to PD1/PD-L1 inhibitors in a noninvasive manner.

Detailed Description

Immunohistochemistry (IHC) is currently the most commonly used method for evaluation of PD-L1 status in cancer patients,including NSCLC. However, biopsies are spatiotemporally limited because of the highly heterogeneous expression of PD-L1. Only 20-40% of PD-L1-positive patients respond to treatment, while 10% of PD-L1-negative patients show a good response to immune checkpoint inhibitors .Patients with false-negative PD-L1 results may miss the chance for targeted therapy.Additionally, the PD-L1 status can change dynamically during the disease process.Therefore, it is necessary to achieve higher response rates, lower toxicity and lower treatment costs by finding assays to better assess PD-L1 expression and screen patients for benefit.

PD-L1 PET imaging provides a new approach to assess PD-L1 expression in NSCLC patients and is expected to overcome the limitations of immunohistochemical ,detection of PD-L1 expression for dynamic visualization in primary and metastatic tumors . First, PET imaging can provide multidimensional three-dimensional data of overall PD-L1 expression in tumors. Second, the whole-body PD-L1 expression level can be assessed, and the heterogeneity of PD-L1 expression between tumors can be studied simultaneously. Third, it is non-invasive and provides information on PD-L1 expression not only before treatment, but also allows monitoring PD-L1 expression several times during treatment ,to screen patients for benefit and guide treatment.

Currently, the FDA-approved 68Ga/68Gagenerator is commercially available, and the cyclotron can produce 68Ga on a large scale. Also, the 68Ga labeling technology is mature. Therefore, 68Ga-PDL1 PET imaging is more easily translatable to the clinical setting. A previous study reported the synthesis and preclinical evaluation of 68Ga-BMS986192, including PD-L1 affinity, metabolic stability, micro PET imaging and in vivo biodistribution in PD-L1 positive and negative transplanted tumors, demonstrating the feasibility of this tracer for in vivo imaging of tumor PD-L1 expression.

Conditions

NSCLC Stage IV; PD-L1 Gene Amplification

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Xiaohua Zhu

OTHER

Sponsor Role: lead

Responsible Party

Xiaohua Zhu

Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

ZHU XIAOHUA, DR

Role: PRINCIPAL_INVESTIGATOR

Tongji Hospital

Locations

TongjiHospital

Wuhan, Hubei, China

Site Status: RECRUITING

Countries

China

Central Contacts

ZHU XIAOHUA, DR

Role: CONTACT

evazhu@vip.sina.com

13971513770 ext. 18012908238

Facility Contacts

xiaohua zhu, Dr.

Role: primary

evazhu@vip.sina.com

13971513770 ext. 86

Other Identifiers

TJ-IRB20220816

Identifier Type: -

Identifier Source: org_study_id