UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061120 |
|---|---|
| Receipt number | R000069875 |
| Scientific Title | A Multicenter Prospective Observational Study of Taletrectinib in Patients with Advanced or Recurrent ROS1 Fusion Positive Non Small Cell Lung Cancer |
| Date of disclosure of the study information | 2026/04/01 |
| Last modified on | 2026/03/31 16:07:26 |
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Basic information
Public title
A Multicenter Prospective Observational Study of Taletrectinib in Patients with Advanced or Recurrent ROS1 Fusion Positive Non Small Cell Lung Cancer (ROSETTA study)(WJOG22925L)
Acronym
ROSETTA study(WJOG22925L)
Scientific Title
A Multicenter Prospective Observational Study of Taletrectinib in Patients with Advanced or Recurrent ROS1 Fusion Positive Non Small Cell Lung Cancer
Scientific Title:Acronym
ROSETTA study(WJOG22925L)
Region
| Japan |
Condition
Condition
Advanced or Recurrent ROS1 Fusion Positive Non Small Cell Lung Cancer
Classification by specialty
| Medicine in general | Pneumology | Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To evaluate the efficacy and safety of Taletrectinib in ROS1 fusion positive advanced or recurrent non small cell lung cancer (NSCLC)through real-world clinical data collection and biomarker measurements.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Progression free survival
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Patients with advanced or recurrent ROS1 fusion positive non small cell lung cancer (NSCLC) that is not amenable to curative treatment.
2. Patients meet one of the following prior treatment criteria:
Cohort A: patients who have not previously received treatment with a ROS1 TKI; or
Cohort B: patients who have previously received treatment with one or more ROS1 TKI.
*There are no restrictions regarding prior treatment with cytotoxic chemotherapy, immune checkpoint inhibitors, or other therapies.
3. Patients who have not previously received taletrectinib and are scheduled to initiate taletrectinib in routine clinical practice in accordance with the latest Japanese package insert. (In principle, treatment with taletrectinib should be initiated after written informed consent has been obtained and patient registration in the electronic data capture (EDC) system has been completed. However, initiation of treatment before EDC registration will be permitted, provided that EDC registration is completed by the next business day after informed consent is obtained.)
4. Patients have undergone radiologic evaluation with CT, including the chest, within 42 days prior to the date of registration, and brain MRI or CT within 56 days prior to the date of registration.Contrast enhanced CT and MRI are preferred; however, non contrast imaging will also be permitted.
5. Patients are aged 18 years or older.
6. Patients have provided written informed consent prior to study registration after receiving a full explanation of the study.
Key exclusion criteria
Patients who are deemed unsuitable for participation in this clinical study by the investigator or treating physician.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Hidetoshi |
| Middle name | |
| Last name | Hayashi |
Organization
Kindai University, Faculty of Medicine
Division name
Department of Medical Oncology
Zip code
590-0197
Address
1-14-1,Miharadai,Minami-ku,Sakai city,Osaka Japan
TEL
072-288-7222
hidet31@med.kindai.ac.jp
Public contact
Name of contact person
| 1st name | Naoki |
| Middle name | |
| Last name | Ishizuka |
Organization
West Japan Oncology Group
Division name
WJOG datacenter
Zip code
556-0016
Address
Namba Plaza Bldg. 304-1-5-7, Motomachi Naniwa-ku, Osaka JAPAN
TEL
06-6633-7400
Homepage URL
https://www.wjog.jp/
datacenter@wjog.jp
Sponsor or person
Institute
West Japan Oncology Group
Institute
Department
Personal name
Funding Source
Organization
Nippon Kayaku Co., Ltd.
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
Kindai University, Faculty of Medicine
Address
1-14-1,Miharadai,Minami-ku,Sakai city,Osaka 590-0197 Japan
Tel
072-288-7222
240452@med.kindai.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 | 04 | 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
Preinitiation
Date of protocol fixation
| 2026 | Year | 03 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2032 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
No special notes.
Management information
Registered date
| 2026 | Year | 04 | Month | 01 | Day |
Last modified on
| 2026 | Year | 03 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000069875
