UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030955 |
|---|---|
| Receipt number | R000034447 |
| Scientific Title | Pembrolizumab as first-line therapy in poor performance status patients with advanced non-small-cell lung cancer highly expressing PD-L1: an open-label, single arm, multicenter, phase II study |
| Date of disclosure of the study information | 2018/04/01 |
| Last modified on | 2022/07/28 20:40:57 |
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Basic information
Public title
Pembrolizumab as first-line therapy in poor performance status patients with advanced non-small-cell lung cancer highly expressing PD-L1: an open-label, single arm, multicenter, phase II study
Acronym
Pembrolizumab in poor performance status patients
Scientific Title
Pembrolizumab as first-line therapy in poor performance status patients with advanced non-small-cell lung cancer highly expressing PD-L1: an open-label, single arm, multicenter, phase II study
Scientific Title:Acronym
Pembrolizumab in poor performance status patients
Region
| Japan |
Condition
Condition
advanced non-small cell lung cancer
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
efficacy of pembrolizumab in patients with NSCLC expressing high PD-L1
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
objective response rate
Key secondary outcomes
progression free survival
overall survival
safety
quality of life
explore possible biomarkers
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
treatment with pembrolizumab
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) age of 20 years or older
2) histologically or cytologically proven non-small cell cancer
3) stage IV, incurable stage IIIB/C, or postoperative recurrent disease
4) treatment naive for lung cancer
5) PD-L1 (TPS = or > 50%)
6) without EGFR mutation or ALK fusion
7) without ROS1 fusion or unknown
8) an Eastern Cooperative Oncology Group performance status of 2 to 3
9) presence of a measurable lesion (RECIST ver. 1.1)
10) without uncontrolled severe comorbidities including pleural effusion, ascites and pericardial effusion, SVC symdrome, or spinal cord compression
11) without a history of palliative radiation therapy within 7 days of registration
12) adequate organ function
13) written informed consent
Key exclusion criteria
1) comordity of auto-immune disease
2) history of organ transplantation
3) symptomatic brain metastasis
(patients with stable condition for more than 7days after radiation will be allowed.)
4) carcinomatous meningitis
5) presence of other cancer within 2 years of registration
6) presence of severe comordity
Target sample size
14
Research contact person
Name of lead principal investigator
| 1st name | Katsuyuki |
| Middle name | |
| Last name | Kiura |
Organization
Okayama University Hospital
Division name
Allergy and respiratory medicine
Zip code
700-8558
Address
2-5-1 Shikata-cho, Kita-ku, Okayama 700-8558, Japan
TEL
086-235-7227
kkiura@md.okayama-u.ac.jp
Public contact
Name of contact person
| 1st name | Eiki |
| Middle name | |
| Last name | Ichihara |
Organization
Okayama University Hospital
Division name
Allergy and respiratory medicine
Zip code
700-8558
Address
+81-86-235-7227
TEL
086-235-7227
Homepage URL
ichiha-e@md.okayama-u.ac.jp
Sponsor or person
Institute
Department of allergy and respiratory medicine
Okayama University Hospital
Institute
Department
Personal name
Funding Source
Organization
Department of allergy and respiratory medicine
Okayama University Hospital
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
Okayama University Hospital Ethics Comittee
Address
2-5-1 Shikata-cho, Kita-ku, Okayama 700-8558, Japan
Tel
086-235-6938
mae6605@adm.okayama-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
| 2018 | Year | 04 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
14
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
Main results already published
Date of protocol fixation
| 2017 | Year | 11 | Month | 28 | Day |
Date of IRB
| 2018 | Year | 02 | Month | 20 | Day |
Anticipated trial start date
| 2018 | Year | 01 | Month | 17 | Day |
Last follow-up date
| 2023 | Year | 09 | Month | 03 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 01 | Month | 23 | Day |
Last modified on
| 2022 | Year | 07 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034447
| 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 |
