UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000061219 |
|---|---|
| Receipt number | R000070050 |
| Scientific Title | A Registry Study of Early-Stage and Locally Advanced KRAS-Mutant Non-Small Cell Lung Cancer |
| Date of disclosure of the study information | 2026/04/10 |
| Last modified on | 2026/04/09 22:56:02 |
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Basic information
Public title
A Registry Study of Early-Stage and Locally Advanced KRAS-Mutant Non-Small Cell Lung Cancer
Acronym
REGORAS
Scientific Title
A Registry Study of Early-Stage and Locally Advanced KRAS-Mutant Non-Small Cell Lung Cancer
Scientific Title:Acronym
REGORAS
Region
| Japan |
Condition
Condition
Non-small cell lung cancer
Classification by specialty
| Pneumology | Chest surgery |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
The objective of this study is to evaluate the prognosis of patients with early-stage or locally advanced non-small cell lung cancer harboring KRAS G12C mutations who have received standard treatment.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
cohort 1:Disease free survival (DFS)
cohort 2:Progression free survival (PFS)
Key secondary outcomes
Overall survival (OS)
Patterns of recurrence or progression
Post-recurrence treatment
Frequency of KRAS gene mutations and their association with clinicopathological characteristics
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
Cohort 0
1 Histologically confirmed NSCLC
2 KRAS G12C mutation confirmed
3 Anatomical lung resection performed on or after June 1, 2025
4 Pathological complete resection
5 Clinical stage II, IIIA, N2 IIIB disease treated with neoadjuvant therapy including immune checkpoint inhibitors, followed by anatomical lung resection
6 Pathological complete response achieved
7 18 years or older
8 Written informed consent from patients
Cohort 1
1 Histologically confirmed NSCLC
2 KRAS G12C mutation confirmed
3 Anatomical lung resection performed on or after June 1, 2025
4 Pathological complete resection
5 Either of the following criteria
a, Patients who underwent surgery without neoadjuvant therapy and were diagnosed with pathological stage II, III disease, and who received (or are scheduled to receive) adjuvant therapy
b, Patients with clinical stage II, IIIA, N2 IIIB disease who received neoadjuvant therapy including immune checkpoint inhibitors followed by anatomical lung resection, regardless of postoperative immunotherapy, and who did not achieve pCR
6 18 years or older
7 Written informed consent from patients
Cohort 2
1 Histologically confirmed NSCLC
2 KRAS G12C mutation confirmed
3 Patients with clinical stage III disease who received definitive chemoradiotherapy on or after June 1, 2025, followed by initiation of durvalumab consolidation therapy or planned to receive
4 18 years or older
5 Written informed consent from patients
Key exclusion criteria
1 Patients with synchronous malignancies requiring treatment at the time of enrollment
2 Patients who declined participation in the study
3 Patients enrolled in a clinical trial using off-label agents for completely resected stage II or III NSCLC or unresectable stage III NSCLC
Target sample size
400
Research contact person
Name of lead principal investigator
| 1st name | Hiroaki |
| Middle name | |
| Last name | Akamatsu |
Organization
Wakayama Medical University
Division name
Internal Medicine III
Zip code
641-8509
Address
811-1, Kimiidera, Wakayama, Japan
TEL
073-441-0619
h-akamat@wakayama-med.ac.jp
Public contact
Name of contact person
| 1st name | Taichi |
| Middle name | |
| Last name | Matsubara |
Organization
Kyushu University Hospital
Division name
Department of 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
Wakayama Medical University
Institute
Department
Personal name
Funding Source
Organization
Eli Lilly Japan K.K.
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
Research Ethics Committee of Wakayama Medical University
Address
811-1, Kimiidera, Wakayama, Japan
Tel
073-447-2300
wa-rinri@wakayama-med.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 | 04 | Month | 10 | 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
| 2026 | Year | 02 | Month | 25 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2035 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
To evaluate the prognosis of patients with early-stage or locally advanced non-small cell lung cancer harboring KRAS G12C mutations who have received standard treatment
Management information
Registered date
| 2026 | Year | 04 | Month | 09 | Day |
Last modified on
| 2026 | Year | 04 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070050
