Imaging Biomarkers for Immune Checkpoint Inhibitor Treatment in Patients With Non-small Cell Lung Cancer

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) treatment response and patient prognosis. 2. Purpose: To evaluate the association between metabolic imaging parameters measured by F-18 FDG PET/CT and clinical outcomes in patients with non-small cell lung cancer treated with ICIs. 3. Study subject: patients with non-small cell lung cancer who will be treated with ICIs. 4. Study design: prospective observational study 5. Intervention: F-18 FDG PET/CT

Sex

All

Minimum age

18 Years

Inclusion Criteria:

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

Exclusion Criteria:

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

• BACKGROUNDTakada K, Toyokawa G, Yoneshima Y, Tanaka K, Okamoto I, Shimokawa M, Wakasu S, Haro A, Osoegawa A, Tagawa T, Oda Y, Nakanishi Y, Mori M. 18F-FDG uptake in PET/CT is a potential predictive biomarker of response to anti-PD-1 antibody therapy in non-small cell lung cancer. Sci Rep. 2019 Sep 16;9(1):13362. doi: 10.1038/s41598-019-50079-2. PMID 31527660
• BACKGROUNDGoldfarb L, Duchemann B, Chouahnia K, Zelek L, Soussan M. Monitoring anti-PD-1-based immunotherapy in non-small cell lung cancer with FDG PET: introduction of iPERCIST. EJNMMI Res. 2019 Jan 29;9(1):8. doi: 10.1186/s13550-019-0473-1. PMID 30694399
• BACKGROUNDHumbert O, Cadour N, Paquet M, Schiappa R, Poudenx M, Chardin D, Borchiellini D, Benisvy D, Ouvrier MJ, Zwarthoed C, Schiazza A, Ilie M, Ghalloussi H, Koulibaly PM, Darcourt J, Otto J. 18FDG PET/CT in the early assessment of non-small cell lung cancer response to immunotherapy: frequency and clinical significance of atypical evolutive patterns. Eur J Nucl Med Mol Imaging. 2020 May;47(5):1158-1167. doi: 10.1007/s00259-019-04573-4. Epub 2019 Nov 23. PMID 31760467
• BACKGROUNDSeban RD, Mezquita L, Berenbaum A, Dercle L, Botticella A, Le Pechoux C, Caramella C, Deutsch E, Grimaldi S, Adam J, Ammari S, Planchard D, Leboulleux S, Besse B. Baseline metabolic tumor burden on FDG PET/CT scans predicts outcome in advanced NSCLC patients treated with immune checkpoint inhibitors. Eur J Nucl Med Mol Imaging. 2020 May;47(5):1147-1157. doi: 10.1007/s00259-019-04615-x. Epub 2019 Nov 21. PMID 31754795