UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060363 |
|---|---|
| Receipt number | R000067512 |
| Scientific Title | A Multicenter Retrospective Observational Study on the Efficacy of ALK-TKIs in ALK Fusion Positive Lung Cancer Patients With Multiplex Gene Test Negative and IHC Positive |
| Date of disclosure of the study information | 2026/01/16 |
| Last modified on | 2026/01/15 15:08:10 |
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Basic information
Public title
Efficacy of ALK-TKIs for IHC-positive/Multiplex-negative ALK lung cancer
Acronym
LOGIK2502/ALKEY
Scientific Title
A Multicenter Retrospective Observational Study on the Efficacy of ALK-TKIs in ALK Fusion Positive Lung Cancer Patients With Multiplex Gene Test Negative and IHC Positive
Scientific Title:Acronym
LOGIK2502/ALKEY
Region
| Japan |
Condition
Condition
Non-small cell lung cancer
Classification by specialty
| Pneumology | Chest surgery | Laboratory medicine |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
The objective of this study is to evaluate the efficacy of ALK inhibitors in ALK fusion-positive lung cancer that tested negative by multiplex testing but positive by IHC, and to examine the positivity rate of ALK fusions using other testing modalities.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
ORR
Key secondary outcomes
OS, TTF, Positivity rate of the ALK fusion gene in other modalities, Patient background that are negative by multiplex testing but positive by IHC (in comparison with cases positive by multiplex testing).
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 a histological diagnosis of non-small cell lung cancer.
(2) Patients who meet any of the following criteria (i) through (iv):
(i) Unresectable Stage III or Stage IV, ineligible for curative radiotherapy.
(ii) Postoperative recurrence.
(iii) Recurrence after curative thoracic radiotherapy, occurring 168 days or more after the final day of irradiation.
(iv) Postoperative pathological Stage II-III without recurrence.
(3) Patients who meet the following criteria 1) and 2) for driver genes.
1) For the ALK fusion gene, meets one of the following (However, for patients with postoperative pathological Stage II-III, only those who meet (a) are eligible):
(a) Tested negative by a multi-gene panel test (e.g., Oncomine, Amoy, Lung Cancer Compact Panel, etc.) performed between June 1, 2019, and March 31, 2025, and confirmed positive by ALK-IHC (e.g., iAEP, D5F3, etc.).
(b) Confirmed positive by a multi-gene panel test performed between June 1, 2019, and March 31, 2025.
2) Negative or unknown status for the following: EGFR mutations, ROS1 fusion gene, BRAF V600E mutation, MET exon 14 skipping alterations, RET fusion gene, and NTRK fusion gene.
Key exclusion criteria
None
Target sample size
140
Research contact person
Name of lead principal investigator
| 1st name | Taichi |
| Middle name | |
| Last name | Matsubara |
Organization
Kyushu University Hospital
Division name
Thoracic Surgery
Zip code
812-8582
Address
3-1-1 Maidashi, Higashi-ku, Fukuoka, Fukuoka, Japan
TEL
092-642-5466
taichi.m0930@gmail.com
Public contact
Name of contact person
| 1st name | Taichi |
| Middle name | |
| Last name | Matsubara |
Organization
Kyushu University Hospital
Division name
Thoracic Surgery
Zip code
812-8582
Address
3-1-1 Maidashi, Higashi-ku, Fukuoka, Fukuoka, Japan
TEL
092-642-5466
Homepage URL
taichi.m0930@gmail.com
Sponsor or person
Institute
Kyushu University
Institute
Department
Personal name
Funding Source
Organization
Chugai Pharmaceutical Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kyushu University Hospital Institutional Review Board
Address
3-1-1 Maidashi, Higashi-ku, Fukuoka, Fukuoka, Japan
Tel
092-642-5082
ijkseimei@jimu.kyushu-u.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 | 01 | Month | 16 | 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 | 09 | Month | 10 | Day |
Date of IRB
| 2025 | Year | 12 | Month | 25 | Day |
Anticipated trial start date
| 2026 | Year | 01 | Month | 16 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
An analysis of efficacy and patient characteristics in patients with ALK fusion-positive lung cancer who are negative by multiplex gene assay but positive by IHC.
Management information
Registered date
| 2026 | Year | 01 | Month | 15 | Day |
Last modified on
| 2026 | Year | 01 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067512
