Tokyo, July 25 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062321) titled 'A study to identify factors associated with the efficacy and adverse effects of treatment combining the PAI-1 inhibitor TM5614 with chemoradiotherapy and immunotherapy for locally advanced non-small cell lung cancer' on July 24.
Study Type:
Observational
Primary Sponsor:
Institute - Hiroshima University
Condition:
Condition - Locally advanced non-small cell lung cancer
Classification by malignancy - Malignancy
Genomic information - NO
Objective:
Narrative objectives1 - As an ancillary biomarker study of the investigator-initiated phase II trial entitled, A Phase II Investigator-Initiated Trial Evaluating the Efficacy and Safety of the PAI-1 Inhibitor TM5614 in Combination with Chemoradiotherapy Followed by Consolidation Therapy with an Immune Checkpoint Inhibitor for Locally Advanced Non-Small Cell Lung Cancer, this study will exploratorily investigate biomarkers that may enable the appropriate selection of patients for the investigational treatment, as well as mechanisms of treatment resistance.
Basic objectives2 - Others
Eligibility:
Age-lower limit - 18
years-old
=
Gender - Male and Female
Key inclusion criteria - Patients enrolled in the parent investigator-initiated phase II trial.
Patients who provide written informed consent to participate in this ancillary study before initiation of the study treatment.
Key exclusion criteria - Not applicable
Target Size - 27
Recruitment Status:
Recruitment status - Open public recruiting
Date of protocol fixation - 2025 Year 10 Month 18 Day
Date of IRB - 2026 Year 06 Month 16 Day
Anticipated trial start date - 2026 Year 06 Month 18 Day
Last follow-up date - 2030 Year 03 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071320
Disclaimer: Curated by HT Syndication.
