Imaging biomarkers for immune checkpoint inhibitor treatment in patients with non-small cell lung cancer
- Conditions
- Neoplasms
- Registration Number
- KCT0007153
- Lead Sponsor
- Samsung Medical Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 100
(1) 18 years old or over
(2) pathologically proven non-small cell lung cancer: adenocarcinoma or squamous cell carcinoma
(3) patients to be treated with immune checkpoint inhibitors (nivolumab or pembrolizumab or atezolizumab)
(4) ECOG performance status = 2
(5) 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
(1) 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.
(2) 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
(3) 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
(4) subjects with uncontrolled diabetes
(5) subjects with severe uncontrolled infection
(6) 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
(7) pregnant or lactating patients
(8) 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)
(9) women or men of childbearing potential who are unwilling to use contraception during the clinical trial period
Study & Design
- Study Type
- Observational Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Association between metabolic imaging parameters and treatment response
- Secondary Outcome Measures
Name Time Method Association between metabolic imaging parameters and patient prognosis; Comparison of clinical outcome according to FDG PET/CT evaluation criteria (PERCIST vs. iPERCIST);Association between metabolic imaging parameters and CT imaging parameters obtained from contrast-enhanced CT; Comparison of FDG PET/CT evaluation criteria with CT evaluation criteria (iRECIST and imRECIST); Association between imaging markers and non-imaging biomarkers; Association between biomarkers and treatment response; Association between biomarkers and patient prognosis