UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062500 |
|---|---|
| Receipt number | R000071339 |
| Scientific Title | A Review of the Current Status of Personalized Medicine for Lung Cancer in the AYA Population and Challenges in Improving Prognosis |
| Date of disclosure of the study information | 2026/08/07 |
| Last modified on | 2026/08/07 09:48:48 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
A Review of the Current Status of Personalized Medicine for Lung Cancer in the AYA Population and Challenges in Improving Prognosis
Acronym
NLCTG2501
Scientific Title
A Review of the Current Status of Personalized Medicine for Lung Cancer in the AYA Population and Challenges in Improving Prognosis
Scientific Title:Acronym
NLCTG2501
Region
| Japan |
Condition
Condition
Locally Advanced or Advanced Non-Small Cell Lung Cancer
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
This study aims to clarify the current status of driver gene mutation frequencies and treatment outcomes among AYA (ages 15-39) lung cancer patients following the introduction of multiplex testing, with the goal of improving the prognosis of AYA lung cancer.
Basic objectives2
Others
Basic objectives -Others
The purpose is to clarify the actual state and outcomes of treatment, as well as the status of social support and whether fertility is taken into consideration.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Frequency of Driver Gene Mutations in Patients Aged 15-39 with Advanced Lung Cancer
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
| 15 | years-old | <= |
Age-upper limit
| 39 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Cases of locally advanced or advanced non-small cell lung cancer diagnosed by histology or cytology in patients aged 15-39 years for whom curative surgery is not an option (including cases of postoperative recurrence)
Key exclusion criteria
Cases in which curative surgery was performed for early-stage non-small cell lung cancer and in which there has been no recurrence
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Satoshi |
| Middle name | |
| Last name | Watanabe |
Organization
Niigata University Graduate School of Medical and Dental Sciences
Division name
Department of Respiratory Medicine and Infectious Diseases
Zip code
951-8510
Address
1-757 Asahimachidori, Chuouku, Niigata
TEL
+81-25-368-9325
satoshi7@med.niigata-u.ac.jp
Public contact
Name of contact person
| 1st name | Shinji |
| Middle name | |
| Last name | Hirose |
Organization
Niigata University Graduate School of Medical and Dental Sciences
Division name
Department of Respiratory Medicine and Infectious Diseases
Zip code
951-8510
Address
1-757 Asahimachidori, Chuouku, Niigata
TEL
09054264593
Homepage URL
res.hirose.08081@gmail.com
Sponsor or person
Institute
Niigata University Graduate School of Medical and Dental Sciences
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee for Human Research, Niigata University
Address
1-757 Asahimachidori, Chuouku, Niigata
Tel
025-227-2625
ethics@adm.niigata-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 | 08 | Month | 07 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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 | 02 | Month | 16 | Day |
Date of IRB
| 2026 | Year | 03 | Month | 04 | Day |
Anticipated trial start date
| 2026 | Year | 03 | Month | 31 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
[Background] Lung cancer in adolescents and young adults (AYAs; 15-39 years) is characterized by frequent driver gene mutations, but outcomes after the introduction of multiplex genomic testing remain unclear. We investigated current treatments and outcomes. [Subjects and Methods] We retrospectively reviewed patients aged 15-39 years with pathologically confirmed locally advanced or advanced non-small cell lung cancer treated at participating institutions of the Niigata Lung Cancer Treatment Study Group between June 2019 and June 2025. [Results] Twenty-two patients were included (median age, 37 years; range, 24-39; 9 males, 13 females). PS 0/1/2/3/4 was 12/7/1/1/1. Histology was adenocarcinoma in 20 and other in 2; stages IIIA/IIIB/IVA/IVB were 4/1/4/13. Two patients were diagnosed during pregnancy. Driver testing was performed in 21 patients, with mutations detected in 19 (EGFR, n=10; ALK, 3; RET, 3; ROS1, 2; KRAS, 1). Initial treatment was surgery (n=2), chemoradiotherapy (n=2), targeted therapy (n=11), or cytotoxic chemotherapy (n=7). Median OS and PFS were 85.6 months (95% CI, 37.4-85.6) and 28.3 months (95% CI, 4.1-42.2). In 16 stage IV patients receiving targeted therapy, median OS and PFS were 61.6 months (95% CI, 25.9-85.6) and 28.3 months (95% CI, 4.1-NE). Educational/employment support was provided to 2 patients and fertility preservation to 1. [Conclusion] Driver mutations were common, and favorable outcomes were achieved. However, few patients used social support services, suggesting the need to improve assessment of support needs and access to relevant information.
Management information
Registered date
| 2026 | Year | 08 | Month | 07 | Day |
Last modified on
| 2026 | Year | 08 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071339
