UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055674 |
|---|---|
| Receipt number | R000063586 |
| Scientific Title | Observational study to investigate safety and effectiveness of lorlatinib as first line treatment for ALK-gene rearranged unresectable advanced/recurrent NSCLC patients in Japan clinical setting |
| Date of disclosure of the study information | 2024/10/01 |
| Last modified on | 2025/04/03 10:08:52 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Observational study to investigate safety and effectiveness of lorlatinib as first line treatment for ALK-positive NSCLC
Acronym
ROYAL study
Scientific Title
Observational study to investigate safety and effectiveness of lorlatinib as first line treatment for ALK-gene rearranged unresectable advanced/recurrent NSCLC patients in Japan clinical setting
Scientific Title:Acronym
ROYAL study
Region
| Japan |
Condition
Condition
ALK-gene rearranged unresectable advanced/recurrent NSCLC patients
Classification by specialty
| Pneumology | Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To describe Adverse Events of special interests (AESIs: CNS AE, Hyperlipidemia, Edema) with information regarding dose modification, and effectiveness of lorlatinib as first line treatment in clinical setting in Japan.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
To characterize AESIs for patients treated with lorlatinib in first line setting.
Key secondary outcomes
･Dose modifications, interruption, or discontinuation (if any) , with related timing and reason
･Time-to-treatment discontinuation (TTD) of lorlatinib.
･1 year, 2 years and 3 years rate of real-world PFS(progression-free survival)/OS(overall survival) of patients on first line lorlatinib treatment
･Real-world ORR(objective response rate) of patients on first line lorlatinib therapy.
･1 year, 2 years and 3 years of real-world IC(Intracranial)-PFS and IC-ORR of patients on first line lorlatinib therapy to investigate effectiveness of lorlatinib for CNS.
･Subsequent treatment after permanent discontinuation of lorlatinib and the TTD of subsequent treatment.
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. Adult (18 years or older) with unresectable advanced/recurrent NSCLC
2. Confirmed ALK gene rearrangement by any validated test.
3. Initiating lorlatinib alone as first line treatment after confirmation of ALK-positive (i.e., no prior treatment with systemic therapy including ALK-TKI ).
4. Evaluated using computed tomography (CT), including the chest, and brain magnetic resonance imaging or CT for baseline assessment.
5. (For only patients who had already initiated lorlatinib before screening) Had at least one followup visit for evaluation of efficiency and safety after lorlatinib initiation.
6. Received lorlatinib after the marketing authorization date for first line treatment (November 25th, 2021) in Japan (for retrospective cases).
7. There is a signed and dated informed consent document (ICD) indicating that the research subject or their legally acceptable representative has been explained all matters related to this study. Furthermore, for patients who have transferred to another hospital, a written document is not mandatory, and registration through verbal informed consent is permitted. (Considering the time and cost required to obtain informed consent, if obtaining informed consent from the research subject or their legally acceptable representative may hinder the implementation of this study, efforts should be made to obtain appropriate consent. Similarly, if it is difficult to obtain appropriate consent for the same reasons, registration through an opt-out method is permitted.)
Key exclusion criteria
No exclusion criteria are set in the study.
Target sample size
75
Research contact person
Name of lead principal investigator
| 1st name | Ai |
| Middle name | |
| Last name | Murata |
Organization
Pfizer Japan Inc.
Division name
Medical Affairs, Oncology
Zip code
151-8589
Address
3-22-7 Yoyogi, Shibuya-ku, Tokyo
TEL
03-5309-7000
ai.murata@pfizer.com
Public contact
Name of contact person
| 1st name | Shoko |
| Middle name | |
| Last name | Tsutsumi |
Organization
Mebix, Inc.
Division name
Division of Research Promotion
Zip code
105-0001
Address
Akasaka Intercity, 1-11-44 Akasaka, Minato-ku, Tokyo
TEL
03-4362-4504
Homepage URL
lorlatinib_1st-line@mebix.co.jp
Sponsor or person
Institute
Pfizer Japan Inc.
Institute
Department
Personal name
Funding Source
Organization
Pfizer Japan Inc.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Aichi Cancer Center's Institutional Review Board
Address
1-1 Kanokoden, Chikusa-ku, Nagoya city, Aichi prefecture, Japan
Tel
052-762-6111
y.fujiwara@aichi-cc.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
1000000117
Org. issuing International ID_1
The European Medicines Agency
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 10 | Month | 01 | 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
Enrolling by invitation
Date of protocol fixation
| 2024 | Year | 07 | Month | 25 | Day |
Date of IRB
| 2024 | Year | 09 | Month | 05 | Day |
Anticipated trial start date
| 2024 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2029 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
1. This is a multicenter, non-interventional study for patients with ALK-positive unresectable advanced/recurrent NSCLC treated with lorlatinib as first line treatment in Japan.
2. All patients who meet eligibility criteria from November 25 2021 to September 30 2026 will be enrolled. .Data will be collected from eligible adults ALK-positive NSCLC treated with lorlatinib as first line treatment from the date of unresectable advanced/recurrent NSCLC diagnosis to the date of death, lost to follow-up, withdrawal of consent or end of study, whichever occurs first.
Management information
Registered date
| 2024 | Year | 09 | Month | 30 | Day |
Last modified on
| 2025 | Year | 04 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063586
