UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041403 |
|---|---|
| Receipt number | R000047258 |
| Scientific Title | A multi-institutional retrospective study of long-term PD-1 pathway inhibitor treatment for patients with non-small cell lung cancer (HOT1902) |
| Date of disclosure of the study information | 2020/08/31 |
| Last modified on | 2021/04/26 17:00:35 |
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Basic information
Public title
A multi-institutional retrospective study of long-term PD-1 pathway inhibitor treatment for patients with non-small cell lung cancer (HOT1902)
Acronym
HOT1902
Scientific Title
A multi-institutional retrospective study of long-term PD-1 pathway inhibitor treatment for patients with non-small cell lung cancer (HOT1902)
Scientific Title:Acronym
HOT1902
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
To evaluate the clinical coarse, the efficacy and safety, of immune check point inhibitor (PD-1 pathway inhibitor) for patients with non-small cell lung cancer
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1.Ratio of patients who can receive immune check point inhibitor for more than 1 year (long-term treatment patients)
2.Efficacy and safety of patients who can receive immune check point inhibitor for more than 1 year (long-term treatment patients)
Key secondary outcomes
Efficacy of ICI rechallenge treatment in long-term treatment patients after progression with prior ICI treatment
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. Advanced/Relapsed non-small cell lung cancer
2.Patients who received immune check point inhibitors between December 2015 and December 2017
Key exclusion criteria
None
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Hajime |
| Middle name | |
| Last name | Asahina |
Organization
Hokkaido University Graduate school of Medicine
Division name
Department Respiratory Medicine, Faculty of Medicine
Zip code
060-8638
Address
North 15, West 7, Kita-ku, Sapporo, 060-8638, Japan
TEL
011-706-5911
asahinah@pop.med.hokudai.ac.jp
Public contact
Name of contact person
| 1st name | Shotaro |
| Middle name | |
| Last name | Ito |
Organization
Hokkaido University Graduate school of Medicine
Division name
Department of Respiratory Medicine, Faculty of Medicine
Zip code
060-8638
Address
North 15, West 7, Kita-ku, Sapporo, 060-8638, Japan
TEL
011-706-5911
Homepage URL
skyhigh0921@pop.med.hokudai.ac.jp
Sponsor or person
Institute
Hokkaido Lung Cancer Clinical Study Group (HOT)
Institute
Department
Personal name
Funding Source
Organization
Hokkaido University Graduate school of Medicine
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
Hokkaido University Hospital Clinical Research and Medical Innovation Center
Address
Kita 14, North 5, Kita-ku, Sapporo, Hokkaido, 060-8648, Japan
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
| 2020 | Year | 08 | Month | 31 | Day |
Related information
URL releasing protocol
https://pubmed.ncbi.nlm.nih.gov/33872943/
Publication of results
Published
Result
URL related to results and publications
https://pubmed.ncbi.nlm.nih.gov/33872943/
Number of participants that the trial has enrolled
676
Results
The median PFS in the LT group was 33.6 months and the median OS in the LT group was not reached.Even in the LT group, 22 of 114 (19.1%) patients died during the follow up period.
Multivariate Cox proportional hazard regression analysis showed that smoking and tumor response (CR) were significantly associated with better PFS.
In the LT group, the median PFSR was 2.9 months. Even in the LT group, the efficacy of rechallenge treatment was limited.
Results date posted
| 2021 | Year | 04 | Month | 26 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
We reviewed the medical records of all consecutive patients with advanced or recurrent NSCLC treated with nivolumab or pembrolizumab at 15 institutions belonging to the Hokkaido Lung Cancer Clinical Study Group Trial (HOT) in Japan.
Participant flow
We did not set any exclusion criteria to avoid selection bias.
Adverse events
In the LT group, 24 of 114 patients discontinued ICI treatment due to irAEs.
Among them, 8 patients had irAEs over grade 3.
Outcome measures
Clinicopathological characteristics of patients undergoing long-term initial ICI treatment
investigate prognostic factors in patients undergoing long-term initial ICI treatment
identify candidates who would benefit from ICI rechallenge treatment and whether ICI rechallenge treatment is effective for patients undergoing long-term initial ICI treatment
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2019 | Year | 08 | Month | 19 | Day |
Date of IRB
| 2019 | Year | 12 | Month | 11 | Day |
Anticipated trial start date
| 2019 | Year | 12 | Month | 11 | Day |
Last follow-up date
| 2019 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2020 | Year | 07 | Month | 01 | Day |
Date trial data considered complete
| 2020 | Year | 07 | Month | 01 | Day |
Date analysis concluded
| 2020 | Year | 08 | Month | 01 | Day |
Other
Other related information
Retrospective observational study
Management information
Registered date
| 2020 | Year | 08 | Month | 13 | Day |
Last modified on
| 2021 | Year | 04 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047258
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