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

NCT05533086 | Unknown DMC

• 1 other identifier: TJ-IRB20220816
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

NSCLC Stage IV; PD-L1 Gene Amplification

Outcome Measures

Primary Outcomes (1)

• SUVmax

  SUVmax

  1 year

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

All patients should be diagnosed with stage IV non-small cell lung cancer. Patients should be eligible for treatment withanti-PD-1/PD-L1 therapy. Patients participating in other trials with this agent may participate in phase one of this study, as long as this does not interfere with either one of the study protocols.

You may qualify if:

• (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.

You may not qualify if:

• \- (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.

Sponsors & Collaborators

• Xiaohua Zhu: lead

Study Sites (1)

TongjiHospital

Wuhan, Hubei, 430030, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• ZHU XIAOHUA, DR

  Tongji Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

ZHU XIAOHUA, DR

CONTACT

13971513770; evazhu@vip.sina.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 6, 2022
• First Posted: September 8, 2022
• Study Start: August 16, 2022
• Primary Completion: August 31, 2024
• Study Completion: August 31, 2025
• Last Updated: February 13, 2023

Record last verified: 2023-02

Locations

CN (1)