UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029601 |
|---|---|
| Receipt number | R000033815 |
| Scientific Title | Safety and efficacy of pembrolizumab as first-line treatment in non-small cell lung cancer patients with poor performance status: a pilot study. |
| Date of disclosure of the study information | 2017/10/18 |
| Last modified on | 2019/05/05 12:44:27 |
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Basic information
Public title
Safety and efficacy of pembrolizumab as first-line treatment in non-small cell lung cancer patients with poor performance status: a pilot study.
Acronym
A pilot study of pembrolizumab as first-line treatment in non-small cell lung cancer patients with poor performance status
Scientific Title
Safety and efficacy of pembrolizumab as first-line treatment in non-small cell lung cancer patients with poor performance status: a pilot study.
Scientific Title:Acronym
A pilot study of pembrolizumab as first-line treatment in non-small cell lung cancer patients with poor performance status
Region
| Japan |
Condition
Condition
non-small cell lung cancer
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To explore the efficacy of pembrolizumab as first-line therapy in non-small cell lung cancer patients with poor performance status
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Progression Free Survival
Key secondary outcomes
Objective Response Rate
Disease Control Rate
Overall survival
QOL
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
pembrolizumab 200mg every 3 weeks
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
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1)ECOG PS 2 or 3
2)Non-small cell lung cancer
3)Stage IIIB or IV or recurrence
4)PD-L1 tumor proportion score of 50% or greater
5)No sensitizing EGFR mutations or ALK translocations
6)Chemotherapy naive
7)Provided written informed consent
8)With adequate organ function
Key exclusion criteria
1)Pleural effusion, ascites or pericardial effusion requiring drainage
2)Other cancers
3)Symptomatic brain metastasis and meningitis
4)With severe complication
5)Interstitial pneumonia on CT
6)Severe drug allergy
7)Active autoimmune disease that has required systemic treatment
8)Dementia
9)Other conditions not suitable for this study
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Noboru Hattori |
Organization
Hiroshima University Hospital
Division name
Department of Respiratory Internal medicine
Zip code
Address
1-2-3 Kasumi, Minami-ku, Hiroshima
TEL
082-257-5196
nhattori@hiroshima-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takeshi Masuda |
Organization
Hiroshima University
Division name
Department of Respiratory Internal medicine, Hiroshima Univestity Hospital
Zip code
Address
1-2-3 Kasumi, Minami-ku, Hiroshima
TEL
082-257-5196
Homepage URL
ta-masuda@hiroshima-u.ac.jp
Sponsor or person
Institute
Hiroshima University 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
Address
Tel
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
広島大学病院
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 10 | Month | 18 | 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
Terminated
Date of protocol fixation
| 2017 | Year | 07 | Month | 20 | Day |
Date of IRB
| 2017 | Year | 10 | Month | 04 | Day |
Anticipated trial start date
| 2017 | Year | 10 | Month | 18 | Day |
Last follow-up date
| 2019 | Year | 02 | Month | 14 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 10 | Month | 17 | Day |
Last modified on
| 2019 | Year | 05 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033815
| 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 |
