Tokyo, Jan. 30 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060483) titled 'Amivantamab and Lazertinib in EGFR-mutated NSCLC: Rick of Thromboembolism - Venous ThromboEmbolism' on Jan. 30.
Study Type:
Observational
Primary Sponsor:
Institute - Kyoto University Hospital
Condition:
Condition - Lung Cancer, Venous Thromboembolism (Pulmonary embolism and deep vein thrombosis)
Classification by malignancy - Malignancy
Genomic information - NO
Objective:
Narrative objectives1 - The primary objective of this study is to investigate the risk of venous thromboembolism (VTE) and bleeding associated with amivantamab/lazertinib combination therapy for EGFR-mutated NSCLC. Furthermore, we believe it will be of significant clinical value to demonstrate the efficacy of prophylactic anticoagulation and validate the appropriateness of its duration.
Basic objectives2 - Safety
Eligibility:
Age-lower limit - 20
years-old
<=
Age-upper limit - Not applicable
Gender - Male and Female
Key inclusion criteria - - Patients aged 20 years or older with EGFR-mutated NSCLC who meet one of the following conditions:
1. Initiating combination therapy with amivantamab and lazertinib.
2. Initiating monotherapy with either amivantamab or lazertinib.
- Patients who have provided written informed consent to participate in this study.
Key exclusion criteria - None.
Target Size - 350
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2026 Year 01 Month 26 Day
Anticipated trial start date - 2026 Year 02 Month 20 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=R000067481
Disclaimer: Curated by HT Syndication.
