UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000061522 |
|---|---|
| Receipt number | R000070400 |
| Scientific Title | Long-Term Follow-Up Analysis of a Phase II Study of Durvalumab Plus Concurrent Definitive Radiation Therapy in Patients with Unresectable Stage III Non-Small Cell Lung Cancer (WJOG11619L: DOLPHIN Study) (WJOG11619LFS) |
| Date of disclosure of the study information | 2026/05/12 |
| Last modified on | 2026/05/11 15:18:48 |
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Basic information
Public title
Long-Term Follow-Up Analysis of a Phase II Study of Durvalumab Plus Concurrent Definitive Radiation Therapy in Patients with Unresectable Stage III Non-Small Cell Lung Cancer (WJOG11619L: DOLPHIN Study) (WJOG11619LFS)
Acronym
DOLPHIN Follow-up Study
Scientific Title
Long-Term Follow-Up Analysis of a Phase II Study of Durvalumab Plus Concurrent Definitive Radiation Therapy in Patients with Unresectable Stage III Non-Small Cell Lung Cancer (WJOG11619L: DOLPHIN Study) (WJOG11619LFS)
Scientific Title:Acronym
WJOG11619LFS (DOLPHIN-LTFU)
Region
| Japan |
Condition
Condition
Non-small cell lung cancer
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The objective is to evaluate the efficacy and safety of durvalumab in combination with definitive radiotherapy through long-term follow-up.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Progression free survival
Key secondary outcomes
Overall survival, late toxicity, patterns of recurrence, subsequent treatments, and differences in treatment efficacy according to patient characteristics and PD-L1 expression (exploratory subgroup analyses)
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 enrolled in WJOG11619L who received at least one course of durvalumab (n=34) and did not meet any of the exclusion criteria will be included.
Key exclusion criteria
- Patients who have declined participation in this study through an opt-out process based on publicly available information
- Patients judged to be unsuitable for inclusion in this study by the principal investigator
Target sample size
34
Research contact person
Name of lead principal investigator
| 1st name | Motoko |
| Middle name | |
| Last name | Tachihara |
Organization
Kobe University Graduate School of Medicine
Division name
Division of Respiratory Medicine, Department of Internal Medicine
Zip code
650-0017
Address
7-5-1 Kusunoki, Chuoku, Kobe, Japan
TEL
078-382-5668
mt0318@med.kobe-u.ac.jp
Public contact
Name of contact person
| 1st name | Naoki |
| Middle name | |
| Last name | Ishizuka |
Organization
West Japan Oncology Group
Division name
WJOG datacenter
Zip code
556-0016
Address
Namba Plaza Bldg. 304-1-5-7, Motomachi Naniwa-ku, Osaka 556-0016 JAPAN
TEL
06-6633-7400
Homepage URL
https://www.wjog.jp/
datacenter@wjog.jp
Sponsor or person
Institute
West Japan Oncology Group
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
Division of Respiratory Medicine, Department of Internal Medicine, Kobe University Graduate School of Medicine, Kobe, Japan
Address
7-5-1 Kusunoki, Chuoku, Kobe, Japan
Tel
078-382-5668
mt0318@med.kobe-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 | 05 | Month | 12 | 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 | 04 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
A long-term follow-up analysis of patients enrolled in the WJOG11619L (DOLPHIN) study to evaluate long-term outcomes and safety.
Management information
Registered date
| 2026 | Year | 05 | Month | 11 | Day |
Last modified on
| 2026 | Year | 05 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070400
