Tokyo, Nov. 13 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000063597) titled 'A Study on Genetic Differences Associated with the Effects of Cancer Immunotherapy in Patients with Non-Small Cell Lung Cancer Who Have Undergone Surgery' on Nov. 13.
Study Type:
Observational
Primary Sponsor:
Institute - Hamamatsu University School of Medicine
Condition:
Condition - Non-Small Cell Lung Cancer
Classification by malignancy - Malignancy
Genomic information - YES
Objective:
Narrative objectives1 - To investigate the association between genetic polymorphisms and the clinical efficacy of immune checkpoint inhibitors in patients with non-small cell lung cancer.
Basic objectives2 - Efficacy
Eligibility:
Age-lower limit - 18
years-old
<=
Age-upper limit - Not applicable
Gender - Male and Female
Key inclusion criteria - This study is intended for patients who meet all of the following criteria.
1. Patients aged 18 years or older diagnosed with resectable non-small cell lung cancer (regardless of PD-L1 TPS value).
2. Patients scheduled to receive or who have received chemotherapy, including an immune checkpoint inhibitor (ICI), as neoadjuvant therapy.
3. Patients who have provided informed consent to participate in this study.
Key exclusion criteria - 1. Under 18 years of age.
2. Has a condition for which immune checkpoint inhibitors are contraindicated.
3. Patients who do not provide informed consent to participate in this study.
4. Patients with a history of autoimmune diseases.
5. Patients who are currently taking immunosuppressive medications.
6. Any other patients deemed ineligible by their attending physician or the principal investigator.
Target Size - 50
Recruitment Status:
Recruitment status - Enrolling by invitation
Date of protocol fixation - 2026 Year 08 Month 01 Day
Date of IRB - 2026 Year 10 Month 30 Day
Anticipated trial start date - 2026 Year 11 Month 16 Day
Last follow-up date - 2031 Year 08 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072457
Disclaimer: Curated by HT Syndication.