UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040223 |
|---|---|
| Receipt number | R000045878 |
| Scientific Title | Retrospective multicenter observation study of Pembrolizumab or Pembrolizumab plus chemotherapy in patients with untreated advanced non small-cell lung cancer highly expressing PD-L1 |
| Date of disclosure of the study information | 2020/05/01 |
| Last modified on | 2022/10/25 17:03:43 |
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Basic information
Public title
Retrospective multicenter observation study of Pembrolizumab or Pembrolizumab plus chemotherapy in patients with untreated advanced non small-cell lung cancer highly expressing PD-L1
Acronym
Retrospective multicenter observation study of Pembrolizumab or Pembrolizumab plus chemotherapy in patients with untreated advanced non small-cell lung cancer highly expressing PD-L1
Scientific Title
Retrospective multicenter observation study of Pembrolizumab or Pembrolizumab plus chemotherapy in patients with untreated advanced non small-cell lung cancer highly expressing PD-L1
Scientific Title:Acronym
Retrospective multicenter observation study of Pembrolizumab or Pembrolizumab plus chemotherapy in patients with untreated advanced non small-cell lung cancer highly expressing PD-L1
Region
| Japan |
Condition
Condition
lung cancer
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
the evaluation of efficacy of pembrolizumab or pembrolizumab plus chemotherapy in patients with untreated advanced non small-cell lung cancer highly expressing PD-L1
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
progression free survival,two year survival rate
Key secondary outcomes
overall survival,response rate,safety
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
2.Highly expressing PD-L1(>50%)
3.Information can be collected with medical records
Key exclusion criteria
1.The positive of EGFR,ALK,ROS-1,BRAF
2.The cases an attending physician determined ineligible.
3.Active concomitant malignancy
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Hidenori |
| Middle name | |
| Last name | Mizugaki |
Organization
Hokkaido University Hospital
Division name
Department of Respiratory Medicine
Zip code
060-8638
Address
North 15, West 7, Kita-ku, Sapporo, Hokkaido
TEL
011-706-5911
hidenori.mizugaki@jfcr.or.jp
Public contact
Name of contact person
| 1st name | Yasuyuki |
| Middle name | |
| Last name | Ikezawa |
Organization
Oji General Hospital
Division name
Department of Respiratory Medicine
Zip code
053-8506
Address
3-4-8 Wakakusa-cho, Tomakomai, Hokkaido
TEL
0144-32-8111
Homepage URL
ikezawa0210yasuyuki@gmail.com
Sponsor or person
Institute
Oji General Hospital
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
Oji General Hospital
Address
3-4-8 Wakakusa-cho, Tomakomai, Hokkaido
Tel
0144-32-8111
ikezawa0210yasuyuki@gmail.com
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 | 05 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
300
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
This study (HOT/NJLCG2001) was performed with a retrospective, multicenter, observational design to evaluate the efficacy and toxicity of MONO or COMB as first line treatments between December 2018 and January 2020.
Participant flow
We reviewed the medical records of all consecutive patients with advanced or recurrent NSCLC with high PD-L1 expression (50%<TPS) and no documented EGFR, ALK, or ROS1 aberrations who were treated with MONO or COMB in 34 institutions that belong to Hokkaido Lung Cancer Clinical Study Group (HOT), North Japan Lung Cancer Study Group (NJLCG) in Japan. The data cutoff was August 31, 2020. This study was approved by the institutional review boards of all institutions, which also waived the need to obtain informed consent because the data were analyzed anonymously.
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2020 | Year | 03 | Month | 10 | Day |
Date of IRB
| 2020 | Year | 04 | Month | 07 | Day |
Anticipated trial start date
| 2020 | Year | 04 | Month | 07 | Day |
Last follow-up date
| 2022 | Year | 01 | Month | 31 | Day |
Date of closure to data entry
| 2022 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2022 | Year | 03 | Month | 31 | Day |
Date analysis concluded
Other
Other related information
none
Management information
Registered date
| 2020 | Year | 04 | Month | 23 | Day |
Last modified on
| 2022 | Year | 10 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045878
| Research Plan | |
|---|---|
| Registered date | File name |
| 2022/10/25 | HOT NJLCG 2001 研究計画書_ver1.2.docx |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
