UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000063214 |
|---|---|
| Receipt number | R000072325 |
| Scientific Title | Co-occurring genomic alterations and outcomes of ALK inhibitor therapy in ALK-positive non-small cell lung cancer |
| Date of disclosure of the study information | 2026/10/08 |
| Last modified on | 2026/10/08 01:09:10 |
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Basic information
Public title
Co-occurring genomic alterations and outcomes of ALK inhibitor therapy in ALK-positive non-small cell lung cancer
Acronym
Co-occurring genomic alterations and outcomes of ALK inhibitor therapy in ALK-positive non-small cell lung cancer
Scientific Title
Co-occurring genomic alterations and outcomes of ALK inhibitor therapy in ALK-positive non-small cell lung cancer
Scientific Title:Acronym
Co-occurring genomic alterations and outcomes of ALK inhibitor therapy in ALK-positive non-small cell lung cancer
Region
| Japan |
Condition
Condition
ALK-rearranged Non-small cell lung cancer
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To describe the distribution of pretreatment co-occurring genomic alterations in ALK-positive non-small cell lung cancer and to exploratorily evaluate the associations of TP53, RB1, and MTAP alterations with progression-free survival and overall survival after first-line ALK inhibitor therapy. An exploratory composite genomic group based on these alterations will also be evaluated, and supportive external analyses will be performed, primarily focusing on RB1, using available clinico-genomic datasets.
Basic objectives2
Others
Basic objectives -Others
To exploratorily evaluate the associations of TP53, RB1, and MTAP alterations with overall survival after first-line ALK inhibitor therapy. Additional analyses will assess outcomes according to combined TP53/RB1 status, EML4-ALK fusion variant, and the type of first-line ALK inhibitor, as well as the co-occurrence of MTAP loss/deletion with CDKN2A/CDKN2B alterations. Exploratory analyses will also evaluate the prognostic relevance of a composite genomic group based on the major candidate alterations, and supportive analyses using available external clinico-genomic datasets will assess the associations of RB1 and TP53 status with survival outcomes.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
PFS according to co-occurring genomic alteration status
Key secondary outcomes
Overall survival (OS) according to the presence or absence of each TP53, RB1, and MTAP alteration.
Frequency and distribution of co-occurring genomic alterations detected by OCA Plus.
PFS and OS according to combined TP53/RB1 status.
PFS and OS according to EML4-ALK fusion variant.
PFS and OS according to the first-line ALK inhibitor used.
Co-occurrence of MTAP loss/deletion with CDKN2A/CDKN2B alterations.
OS according to RB1 and TP53 status in an external clinico-genomic dataset.
Exploratory associations of a composite genomic group based on the major candidate alterations with PFS and OS.
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
1. Patients with pathologically or cytologically confirmed non-small cell lung cancer
2. Patients with confirmed ALK rearrangement
3. Patients treated at the study institution between March 2012 and May 2025
4. Patients with available genomic data obtained by comprehensive genomic profiling
5. Patients with available clinical information required to evaluate ALK inhibitor treatment and clinical outcomes
Key exclusion criteria
1. Patients with insufficient genomic information for evaluation of the association with treatment outcomes
2. Patients for whom the clinical course after ALK inhibitor therapy or survival information cannot be adequately evaluated
3. Patients considered inappropriate for analysis by the principal investigator
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Kentaro |
| Middle name | |
| Last name | Ito |
Organization
Saiseikai Matsusaka Municipal Hospital
Division name
Respiratory Center
Zip code
5150073
Address
1550, Tonomachi, Matsusaka city, Mie, Japan
TEL
0598231515
kentarou_i_0214@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Kentaro |
| Middle name | |
| Last name | Ito |
Organization
Saiszeikai Matsusaka Municipal Hospital
Division name
Respiratory Center
Zip code
5150073
Address
1550, Tonomachi , Matsusaka City, Mie , Japan
TEL
0598231515
Homepage URL
kentarou_i_0214@yahoo.co.jp
Sponsor or person
Institute
Saiseikai Matsusaka Municipal Hospital
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Saiseikai Matsusaka Municipal Hospital
Address
1550, Tonomachi, Matsusaka city, Mie, Japan
Tel
08045407616
kentarou_i_0214@yahoo.co.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 | 10 | Month | 08 | 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
30
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
No longer recruiting
Date of protocol fixation
| 2026 | Year | 08 | Month | 15 | Day |
Date of IRB
| 2026 | Year | 08 | Month | 21 | Day |
Anticipated trial start date
| 2026 | Year | 08 | Month | 21 | Day |
Last follow-up date
| 2026 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This is a single-center retrospective observational study of patients with ALK-rearranged non-small cell lung cancer. The study will exploratively evaluate the association between co-occurring genomic alterations other than ALK identified by comprehensive genomic profiling and clinical outcomes of ALK inhibitor therapy. In particular, co-occurring alterations involving TP53, RB1, and MTAP will be evaluated in relation to progression-free survival (PFS) and overall survival (OS).
Eligible patients treated at the study institution during the predefined study period will be retrospectively identified. No random or case-control sampling will be performed, and consecutively identifiable eligible patients with evaluable data will be included. No additional examination, treatment, or intervention will be performed for research purposes.
Supportive analyses using available external clinical genomic datasets will also be conducted to evaluate the association between major candidate genomic alterations and prognosis.
Management information
Registered date
| 2026 | Year | 10 | Month | 08 | Day |
Last modified on
| 2026 | Year | 10 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072325
