Status:
RECRUITING
Imaging Biomarkers for Immune Checkpoint Inhibitor Treatment in Patients With Non-small Cell Lung Cancer
Lead Sponsor:
Samsung Medical Center
Conditions:
Carcinoma, Non-Small-Cell Lung
Immune Checkpoint Inhibitors
Eligibility:
All Genders
18+ years
Brief Summary
1. Hypothesis : imaging biomarkers of tumor measured by F-18 fluorodeoxyglucose (FDG) positron emission tomography(PET)/computed tomography(CT) is correlated with immune checkpoint inhibitor (ICI) tre...
Detailed Description
1\. Study purposes 1. Primary purpose: To evaluate the association between metabolic imaging parameters measured by F-18 FDG PET/CT and treatment response in non-small cell lung cancer (NSCLC) patien...
Eligibility Criteria
Inclusion
- 18 years old or over
- pathologically proven non-small cell lung cancer: adenocarcinoma or squamous cell carcinoma
- patients to be treated with immune checkpoint inhibitors (nivolumab or pembrolizumab or atezolizumab)
- ECOG performance status ≤ 2
- A person who have heard the detailed explanation of this clinical trial and are willing to voluntarily decide to participate and sign the informed consent form
Exclusion
- subjects without measurable lesion: They must have at least one measurable lesion with a diameter of 10 mm by spiral CT or multi-detector CT (MD CT) or 20 mm or larger by conventional CT.
- subjects with a history of other malignant diseases within the past 5 years, except for treated basal cell carcinoma of the skin, carcinoma in situ of the cervix, cured thyroid cancer, and early gastric cancer
- subjects with clinically significant uncontrolled seizures, central nervous system disease, or psychiatric disorders that, in the investigator's judgment, interferes with or is likely to interfere with the understanding of informed consent
- subjects with uncontrolled diabetes
- subjects with severe uncontrolled infection
- subjects who underwent major surgery within 4 weeks prior to the start of the clinical trial or who have not fully recovered from the effects of major surgery
- pregnant or lactating patients
- subjects who have not received a pregnancy test or have a positive result during the basic test (menopause women with amenorrhea period of at least 12 months or longer are considered infertile subjects)
- women or men of childbearing potential who are unwilling to use contraception during the clinical trial period
Key Trial Info
Start Date :
May 9 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT05260606
Start Date
May 9 2022
End Date
December 1 2025
Last Update
April 17 2024
Active Locations (1)
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1
Samsung Medical Center
Seoul, South Korea, 06351