Tokyo, Aug. 27 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062700) titled 'Pembrolizumab dose-optimization study with Regression discontinuity design In patients with non-small cell lung Cancer to avert Excessive toxicity and cost (PRICE): Sub-study' on Aug. 27.
Study Type:
Observational
Primary Sponsor:
Institute - Public Health Research Foundation
Condition:
Condition - Non-Small Cell Lung Cancer
Classification by malignancy - Malignancy
Genomic information - NO
Objective:
Narrative objectives1 - In patients enrolled in the PRICE trial who meet all the eligibility criteria for this sub-study, to measure the plasma concentrations of pembrolizumab and conduct an exploratory analysis to identify the optimal dose of pembrolizumab.
Basic objectives2 - Pharmacokinetics
Eligibility:
Age-lower limit - 20
years-old
<=
Age-upper limit - Not applicable
Gender - Male and Female
Key inclusion criteria - 1) Patients enrolled in the PRICE trial
2) Patients who have provided written informed consent to participate in this sub-study
Key exclusion criteria - 1) Patients from whom consent cannot be obtained for specimen collection
2) Any other patients whom the principal investigator or the attending physician determines are not suitable for inclusion in this sub-study
Target Size - 100
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2026 Year 04 Month 27 Day
Date of IRB - 2026 Year 06 Month 16 Day
Anticipated trial start date - 2026 Year 09 Month 01 Day
Last follow-up date - 2028 Year 09 Month 30 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071783
Disclaimer: Curated by HT Syndication.
