UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059583 |
|---|---|
| Receipt number | R000068148 |
| Scientific Title | Alectinib and Local Therapy for Optimal Treatment in ALK-Positive non-small cell lung cancer (ALTHEO Study) |
| Date of disclosure of the study information | 2025/10/30 |
| Last modified on | 2025/10/29 19:23:49 |
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Basic information
Public title
Alectinib and Local Therapy for Optimal Treatment in ALK-Positive non-small cell lung cancer (ALTHEO Study)
Acronym
NEJ069 ALTHEO Study
Scientific Title
Alectinib and Local Therapy for Optimal Treatment in ALK-Positive non-small cell lung cancer (ALTHEO Study)
Scientific Title:Acronym
NEJ069 ALTHEO Study
Region
| Japan |
Condition
Condition
ALK fusion gene-positive lung cancer.
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
This study aims to elucidate the clinical significance of performing local treatment for brain metastases before systemic therapy in patients with ALK-positive lung cancer with brain metastases.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Presence and details of local treatment for brain metastases, and survival outcomes (overall survival [OS], progression-free survival [PFS], and central nervous system progression-free survival [CNS-PFS]).
The study includes calculation of the proportion of patients who experienced progression or newly developed brain metastases during alectinib treatment; assessment of the presence and details of local treatment for brain metastases; evaluation of survival outcomes (overall survival [OS], progression-free survival [PFS], and central nervous system progression-free survival [CNS-PFS]); analysis of survival in patients who continued alectinib after receiving additional local treatment for progressive or newly developed brain metastases; and investigation of the impact of new-onset brain metastases on prognosis (OS and PFS).
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who started treatment with Alectinib for advanced or recurrent NSCLC with ALK fusion gene positivity between September 1, 2014 and December 31, 2022.
Key exclusion criteria
1. Patients with a history of ALK-TKI administration prior to alectinib administration (patients with a history of chemotherapy other than ALK-TKI are eligible for inclusion).
2. Patients with meningeal carcinomatosis prior to alectinib administration.
3. Patients who refused to participate in this study based on the informed consent document.
4. Patients whom the principal investigator or co-investigator deemed unsuitable for participation in this study.
Target sample size
700
Research contact person
Name of lead principal investigator
| 1st name | Masahiro |
| Middle name | |
| Last name | Seike |
Organization
Nippon Medical School Hospital
Division name
Department of Pulmonary Medicine and Oncology
Zip code
1138603
Address
1-1-5 Sendagi, Bunkyo-ku, Tokyo
TEL
03-3822-2131
mseike@nms.ac.jp
Public contact
Name of contact person
| 1st name | Susumu |
| Middle name | |
| Last name | Takeuchi |
Organization
Nippon Medical School Hospital
Division name
Department of Pulmonary Medicine and Oncology
Zip code
1138603
Address
1-1-5 Sendagi, Bunkyo-ku, Tokyo
TEL
03-3822-2131
Homepage URL
s-takeuchi@nms.ac.jp
Sponsor or person
Institute
Specified Nonprofit Corporation North East Japan Study Group
Institute
Department
Personal name
Funding Source
Organization
CHUGAI PHARMACEUTICAL 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
Central Ethics Comittee of the Nippon Medical School
Address
1-1-5 Sendagi, Bunkyo-ku, Tokyo
Tel
03-3822-2131
chuorinri.group@nms.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
| 2025 | Year | 10 | 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
Open public recruiting
Date of protocol fixation
| 2025 | Year | 10 | Month | 13 | Day |
Date of IRB
| 2025 | Year | 10 | Month | 13 | Day |
Anticipated trial start date
| 2025 | Year | 10 | Month | 20 | Day |
Last follow-up date
| 2028 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Multicenter Retrospective Observational Study
Management information
Registered date
| 2025 | Year | 10 | Month | 29 | Day |
Last modified on
| 2025 | Year | 10 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068148
