UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056248 |
|---|---|
| Receipt number | R000064185 |
| Scientific Title | Lorlatinib for Brain metastases in ALK-Positive NSCLC Patients:a Multicenter Prospective Observational Stud |
| Date of disclosure of the study information | 2024/11/23 |
| Last modified on | 2024/11/23 13:30:42 |
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Basic information
Public title
Lorlatinib for Brain metastases in ALK-Positive NSCLC Patients:a Multicenter Prospective Observational Study
Acronym
LOBSTER/CJLSG2401
Scientific Title
Lorlatinib for Brain metastases in ALK-Positive NSCLC Patients:a Multicenter Prospective Observational Stud
Scientific Title:Acronym
LOBSTER/CJLSG2401
Region
| Japan |
Condition
Condition
Non-small cell lung cancer
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to prospectively enroll patients with ALK-positive advanced non-small cell lung cancer with brain metastases who are scheduled to start lorlatinib monotherapy, and to investigate the efficacy and safety of lorlatinib monotherapy in the Japanese patient population by collecting clinical information from actual clinical practice. This study will particularly focus on evaluating efficacy against brain metastases and central nervous system adverse events.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Central nervous system metastases complete response rate: CNS-CR rate
Key secondary outcomes
(1) Overall survival (OS)
(2) Overall response rate (ORR)
(3) Progression free survival (PFS)
(4) Response rate for CNS metastases (CNS-ORR)
(5) Progression-free survival for CNS metastases (CNS-PFS)
(6) Safety
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 unresectable advanced or recurrent NSCLC
2) ALK-positive confirmed by validated tests
3) Age 18 or older at the time consent is obtained
4) No history of ALK-TKI treatment
5) Lorlatinib at 100 mg once daily is scheduled to be administered
6) CNS metastasis with a maximum diameter of 5 mm or more and 2 times the slice width on head MRI (contrast MRI whenever possible, within 42 days prior to registration in principle, when selecting a lesion with a long diameter of 5-10 mm, carefully check that the MRI slice thickness is half or less of the long diameter)
7) Patients who have had a chest CT scan within 42 days prior to enrollment (regardless of whether or not there are measurable lesions other than CNS metastases)
8) Expected to survive at least 12 weeks at time of enrollment
Key exclusion criteria
No exclusion criteria in this study.
Target sample size
24
Research contact person
Name of lead principal investigator
| 1st name | Akito |
| Middle name | |
| Last name | Hata |
Organization
Kobe Minimally Invasive Cancer Center
Division name
Division of Thoracic Oncology
Zip code
650-0046
Address
8-5-1, Minatojima-nakamachi, Chuo-ku, Kobe, Hyogo
TEL
078-304-4100
akitohata@hotmail.com
Public contact
Name of contact person
| 1st name | Teppei |
| Middle name | |
| Last name | Yamaguchi |
Organization
Aichi Cancer Center Hospital
Division name
Department of Thoracic Oncology
Zip code
464-8681
Address
1-1 Kanokoden, Chikusa-ku, Nagoya, Aichi
TEL
052-762-6111
Homepage URL
yteppei@aichi-cc.jp
Sponsor or person
Institute
Kobe Minimally Invasive Cancer Center
Institute
Department
Personal name
Funding Source
Organization
Pfizer Inc.
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Aichi Cancer Center Hospital
Address
1-1 Kanokoden, Chikusa-ku, Nagoya, Aichi 464-8681, Japan
Tel
052-762-6111
yteppei@aichi-cc.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
医療法人社団 神戸低侵襲がん医療センター(兵庫県）
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 11 | Month | 23 | 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
Open public recruiting
Date of protocol fixation
| 2024 | Year | 11 | Month | 21 | Day |
Date of IRB
| 2024 | Year | 11 | Month | 21 | Day |
Anticipated trial start date
| 2024 | Year | 11 | Month | 21 | Day |
Last follow-up date
| 2031 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Multicenter, single-arm, prospective observation Study
Management information
Registered date
| 2024 | Year | 11 | Month | 23 | Day |
Last modified on
| 2024 | Year | 11 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064185
