UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060483 |
|---|---|
| Receipt number | R000067481 |
| Scientific Title | Amivantamab and Lazertinib in EGFR-mutated NSCLC: Rick of Thromboembolism - Venous ThromboEmbolism |
| Date of disclosure of the study information | 2026/01/30 |
| Last modified on | 2026/01/27 14:32:46 |
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Basic information
Public title
Amivantamab and Lazertinib in EGFR-mutated NSCLC: Rick of Thromboembolism - Venous ThromboEmbolism
Acronym
ALERT-VTE
Scientific Title
Amivantamab and Lazertinib in EGFR-mutated NSCLC: Rick of Thromboembolism - Venous ThromboEmbolism
Scientific Title:Acronym
ALERT-VTE
Region
| Japan |
Condition
Condition
Lung Cancer, Venous Thromboembolism (Pulmonary embolism and deep vein thrombosis)
Classification by specialty
| Cardiology | Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
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
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Incidence of venous thromboembolism and bleeding from treatment initiation to the end of the follow-up period
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
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 sample size
350
Research contact person
Name of lead principal investigator
| 1st name | Eri |
| Middle name | |
| Last name | Kato |
Organization
Kyoto University Hospital
Division name
Department of Cardiovascular Medicine, Preemptive Medicine and Lifestyle Related Disease Research Center
Zip code
606-8507
Address
54 Shogoin Kawahara-cho, Sakyo-ku, Kyoto-shi, Kyoto, Japan
TEL
075-751-4255
erikato@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Yuto |
| Middle name | |
| Last name | Miura |
Organization
Kyoto University Graduate School of Medicine
Division name
Department of Cardiovascular Medicine
Zip code
606-8507
Address
54 Shogoin Kawahara-cho, Sakyo-ku, Kyoto-shi, Kyoto, Japan
TEL
075-751-4255
Homepage URL
myuto_knzw@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto University Hospital
Institute
Department
Personal name
Funding Source
Organization
Kyoto University Hospital
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Mie University Hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kyoto University Graduate School and Faculty of Medicine, Kyoto University Hospital Ethics Committe
Address
Yoshida-Konoe-cho, Sakyo-ku, Kyoto-shi, Kyoto, Japan
Tel
075-753-4680
ethcom@kuhp.kyoto-u.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 01 | Month | 30 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2026 | Year | 01 | Month | 26 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 02 | Month | 20 | Day |
Last follow-up date
| 2030 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
ALERT-VTE study is a multicenter, prospective registry enrolling patients receiving amivantamab and/or lazertinib for EGFR-mutated NSCLC between 2026 and 2029.
Management information
Registered date
| 2026 | Year | 01 | Month | 27 | Day |
Last modified on
| 2026 | Year | 01 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067481
