UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061941 |
|---|---|
| Receipt number | R000070871 |
| Scientific Title | Real-World Characteristics, Treatment Patterns, and Outcomes of Patients with cEGFRm NSCLC Treated with Ami+Lazer, Osi+Chemo and Osi-Mono in the 1L Setting (REDAdmiral): A Non-Interventional, Multi-Country, Multi-Center, Multi-Wave, Retrospective Chart Review Study |
| Date of disclosure of the study information | 2026/06/29 |
| Last modified on | 2026/06/17 11:46:45 |
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Basic information
Public title
Real-World Characteristics, Treatment Patterns, and Outcomes of Patients with cEGFRm NSCLC Treated with amivantamab + lazertinib, osimertinib + chemotherapy, and osimertinib monotherapy in the 1L Setting (REDAdmiral): A Non-Interventional, Multi-Country, Multi-Center, Multi-Wave, Retrospective Chart Review Study
Acronym
REDAdmiral
Scientific Title
Real-World Characteristics, Treatment Patterns, and Outcomes of Patients with cEGFRm NSCLC Treated with Ami+Lazer, Osi+Chemo and Osi-Mono in the 1L Setting (REDAdmiral): A Non-Interventional, Multi-Country, Multi-Center, Multi-Wave, Retrospective Chart Review Study
Scientific Title:Acronym
REDAdmiral Study
Region
| Japan | Asia(except Japan) | North America |
| South America | Europe | Africa |
Condition
Condition
Non-small cell lung cancer
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
collecting and analyzing data for adults with advanced/metastatic cEGFRm NSCLC treated with Ami+Lazer, Osi+Chemo, or Osi-Mono (optional cohort) in the real-world 1L setting.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
the real-world patient profiles, treatment patterns, clinical outcomes (effectiveness and safety), and HCRU-related outcomes of 1L Ami+Lazer, Osi+Chemo, and Osi-Mono in patients with advanced/metastatic cEGFRm NSCLC
Key secondary outcomes
None
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.Confirmed diagnosis of advanced/metastatic cEGFRm (Ex19del or L858R) NSCLC.
2.Initiation of first-line treatment in real-world clinical practice with Ami+Lazer, Osi+Chemo, or Osi-Mono (optional cohort), with at least one dose of each agent in the regimen administered.
a. The first-line treatment must be prescribed by the participating site or physician (if a retrospective site-/panel-based chart review approach is used).
b. The index date is defined as the date of first administration of any agent in the regimen.
c. Chemotherapy as part of the Osi+Chemo regimen includes pemetrexed and a platinum agent (carboplatin or cisplatin).
3.Aged 18 years or older at the index date.
4.If applicable and in accordance with local requirements, the patient (and/or, where applicable, a legally acceptable representative) has signed the participation agreement or informed consent form (ICF) and provided permission for direct access to source documents (the ICF may be waived if approved by the Independent Ethics Committee [IEC] or Institutional Review Board [IRB]).
Key exclusion criteria
1.Enrolled in a clinical trial for any part of 1L treatment in advanced/metastatic NSCLC
However, in Japan, patients enrolled in a clinical trial and receiving treatment with either Ami + Lazer or Osi + Chemotherapy under the national health insurance system shall be eligible for inclusion in this study.
2.Receipt of 1L treatment (e.g., Ami+Lazer, Osi+Chemo, Osi-Mono) in combination with another systemic treatment medication (e.g., bevacizumab, ramucirumab, erlotinib, gefitinib) in the 1L setting
Target sample size
750
Research contact person
Name of lead principal investigator
| 1st name | Pauline |
| Middle name | |
| Last name | Ng |
Organization
Janssen Pharmaceutical K.K.
Division name
Medical Affairs Division
Zip code
101-0065
Address
3-5-2 Nishikanda, Chiyoda-ku, Tokyo, 101-0065, Japan
TEL
03-4411-7700
SKitazon@ITS.JNJ.com
Public contact
Name of contact person
| 1st name | Tomomi |
| Middle name | |
| Last name | Imai |
Organization
IQVIA Services Japan G.K.
Division name
Real-World Evidence Services
Zip code
108-0074
Address
4-10-18 Takanawa, Minato-ku, Tokyo, 108-0074, Japan
TEL
03-6859-9500
Homepage URL
REDAdmiral@iqvia.com
Sponsor or person
Institute
Janssen Pharmaceutical K.K.
Institute
Department
Personal name
Funding Source
Organization
Janssen Pharmaceutical K.K.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
None
Name of secondary funder(s)
None
IRB Contact (For public release)
Organization
Non-Profit Organization MINS Research Ethics Committee
Address
5-20-9-401 Mita, Minato-ku, Tokyo, Japan
Tel
03-6416-1868
npo-mins@j-irb.com
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 | 06 | Month | 29 | 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
| 2025 | Year | 11 | Month | 07 | Day |
Date of IRB
| 2026 | Year | 05 | Month | 21 | Day |
Anticipated trial start date
| 2026 | Year | 06 | Month | 29 | Day |
Last follow-up date
| 2033 | Year | 11 | Month | 30 | Day |
Date of closure to data entry
| 2033 | Year | 11 | Month | 30 | Day |
Date trial data considered complete
| 2034 | Year | 04 | Month | 17 | Day |
Date analysis concluded
Other
Other related information
In Japan, written informed consent is required. However, if the patient is already deceased or cannot be contacted, an opt-out approach will be applied.
Management information
Registered date
| 2026 | Year | 06 | Month | 17 | Day |
Last modified on
| 2026 | Year | 06 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070871
