UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000048100 |
|---|---|
| Receipt number | R000054803 |
| Scientific Title | Durvalumab after chemoradiotherapy in non-small cell lung cancer harboring driver gene mutation/translocation: a retrospective multicenter study (HOT2101) |
| Date of disclosure of the study information | 2022/06/20 |
| Last modified on | 2023/06/20 10:53:58 |
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Basic information
Public title
Durvalumab after chemoradiotherapy in non-small cell lung cancer harboring driver gene mutation/translocation: a retrospective multicenter study (HOT2101)
Acronym
HOT2101
Scientific Title
Durvalumab after chemoradiotherapy in non-small cell lung cancer harboring driver gene mutation/translocation: a retrospective multicenter study (HOT2101)
Scientific Title:Acronym
HOT2101
Region
| Japan |
Condition
Condition
non-small cell lung cancer
Classification by specialty
| Pneumology | Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
We evaluated consecutive patients with locally advanced or postoperative recurrent, unresectable NSCLC harboring driver gene positive who received CRT to describe the clinical characteristics and outcomes of these patients.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To provide insights into outcomes of durvalumab consolidation efficacy and safety in non-small cell lung cancer harboring driver gene mutation/translocation.
Key secondary outcomes
1. progression free survival
2. overall survival
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. Histologically- or cytologically-confirmed NSCLC with driver gene positive defined as EGFR, ALK, ROS1, BRAF, NTRK, MET, RET, and KRAS by December 31, 2021.
2. Patients with locally advanced or postoperative recurrent, unresectable NSCLC.
3. Patients who do not refuse to participate in this study.
Key exclusion criteria
Patients who were deemed inappropriate for enrollment by investigators
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Hidenori |
| Middle name | |
| Last name | Mizugaki |
Organization
The Cancer Institute Hospital of Japanese Foundation for Cancer Research
Division name
Department of Advanced Medical Development
Zip code
135-8550
Address
3-8-31, Ariake, Koto-ku, Tokyo, 135-8550, Japan
TEL
03-3520-0141
hidenori.mizugaki@jfcr.or.jp
Public contact
Name of contact person
| 1st name | Kosuke |
| Middle name | |
| Last name | Tsuji |
Organization
Hokkaido University Graduate School of Medicine
Division name
Department of Respiratory Medicine
Zip code
060-8638
Address
North 15, West 7, Kita-ku, Sapporo, 060-8638, Japan
TEL
011-706-5911
Homepage URL
kosuke_ko17@pop.med.hokudai.ac.jp
Sponsor or person
Institute
Hokkaido Lung Cancer Clinical Study Group(HOT)
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
Ethical Review Board for Life Science and Medical Research, Hokkaido University Hospital
Address
Kita14 Nishi5, Kita-ku, Sapporo, Hokkaido
Tel
011-706-7636
crjimu@huhp.hokudai.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
| 2022 | Year | 06 | 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
88
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
| 2021 | Year | 12 | Month | 15 | Day |
Date of IRB
| 2021 | Year | 12 | Month | 22 | Day |
Anticipated trial start date
| 2021 | Year | 12 | Month | 31 | Day |
Last follow-up date
| 2023 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2024 | Year | 12 | Month | 31 | Day |
Other
Other related information
Retrospective observational study
Management information
Registered date
| 2022 | Year | 06 | Month | 19 | Day |
Last modified on
| 2023 | Year | 06 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000054803
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
