UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000051670 |
|---|---|
| Receipt number | R000058967 |
| Scientific Title | A multicenter retrospective observational study to evaluate the efficacy and safety of durvalumab following concurrent chemoradiotherapy for stage III non-small cell lung cancer harboring EGFR mutation (NEJ063 study) |
| Date of disclosure of the study information | 2023/07/20 |
| Last modified on | 2023/07/20 21:59:42 |
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Basic information
Public title
A multicenter retrospective observational study to evaluate the efficacy and safety of durvalumab following concurrent chemoradiotherapy for stage III non-small cell lung cancer harboring EGFR mutation (NEJ063 study)
Acronym
NEJ063 study
Scientific Title
A multicenter retrospective observational study to evaluate the efficacy and safety of durvalumab following concurrent chemoradiotherapy for stage III non-small cell lung cancer harboring EGFR mutation (NEJ063 study)
Scientific Title:Acronym
NEJ063 study
Region
| Japan |
Condition
Condition
Non-small cell lung cancer
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To determine the benefit of durvalumab in patients with EGFR-mutated stage III non-small cell lung cancer treated with concurrent radical chemoradiotherapy and to identify clinical factors that may benefit from durvalumab therapy.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Progression free survival from the end of chemoradiotherapy in the chemoradiotherapy plus durvalumab and chemoradiotherapy alone groups
Key secondary outcomes
1) Overall survival from the time of completion of chemoradiotherapy in the chemoradiotherapy plus durvalumab and chemoradiotherapy alone groups
2) Progression-free survival and overall survival by year from the end of chemoradiation therapy in the chemoradiation therapy plus durvalumab and chemoradiation therapy alone groups
3) Treatment safety in patients receiving chemoradiation followed by durvalumab
4) Patient characteristics of the long-term progression-free survival cohort in the durvalumab arm
5) Safety of EGFR-TKI as post-therapy in patients treated with durvalumab
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 must be initiated on concurrent curative chemoradiotherapy between July 1, 2015 and June 30, 2022 and meet all of the following criteria.
(1) Patients diagnosed with non-small cell lung cancer by histological or cytological diagnosis and confirmed positive for EGFR mutation.
(2) Patients with clinical stage IIIA to IIIC at the start of chemoradiotherapy, including postoperative recurrence cases.
(3) Patients who have completed chemoradiotherapy and have no evidence of disease progression at the first efficacy evaluation after completion of chemoradiotherapy (Stable disease or higher by RECIST v.1.1).
Key exclusion criteria
(1) Cases treated with sequential combination of chemotherapy and radiotherapy.
(2)Cases that the physician judged to be inappropriate for reasons such as inability to collect the information necessary to fill out the CRF.
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Eisaku |
| Middle name | |
| Last name | Miyauchi |
Organization
Tohoku University Hospital
Division name
Department of Respiratory Medicine
Zip code
98008574
Address
1-1, Seiryomachi, Aobaku, Sendai, Miyagi
TEL
022-717-8539
miyauchi@rm.med.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Toshiya |
| Middle name | |
| Last name | Fujisaki |
Organization
Tachikawa General Hospital
Division name
Department of Respiratory Medicine
Zip code
940-8621
Address
1-24, Asahioka, Nagaoka, Niigata
TEL
0258-33-3111
Homepage URL
toshiyafujisaki100@gmail.com
Sponsor or person
Institute
Tohoku University Hospital
Institute
Department
Personal name
Eisaku Miyauchi
Funding Source
Organization
University grants
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee Tohoku University Graduate School of Medicine
Address
2-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi, 980-8575, Japan
Tel
022-717-8007
med-kenkyo@grp.tohoku.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
| 2023 | Year | 07 | Month | 20 | 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
| 2023 | Year | 07 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2023 | Year | 09 | Month | 30 | 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
None
Management information
Registered date
| 2023 | Year | 07 | Month | 20 | Day |
Last modified on
| 2023 | Year | 07 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000058967
| Research Plan | |
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| Registered date | File name |
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