UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044052 |
|---|---|
| Receipt number | R000050176 |
| Scientific Title | Prospective observation study for poor PS or elderly non-small cell lung cancer patients treated with Pembrolizumab monotherapy as a first line setting |
| Date of disclosure of the study information | 2021/05/07 |
| Last modified on | 2023/01/13 09:16:34 |
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Basic information
Public title
Prospective observation study for poor PS or elderly non-small cell lung cancer patients treated with Pembrolizumab monotherapy as a first line setting
Acronym
Prospective observation study for poor PS or elderly non-small cell lung cancer patients treated with Pembrolizumab monotherapy as a first line setting
Scientific Title
Prospective observation study for poor PS or elderly non-small cell lung cancer patients treated with Pembrolizumab monotherapy as a first line setting
Scientific Title:Acronym
Prospective observation study for poor PS or elderly non-small cell lung cancer patients treated with Pembrolizumab monotherapy as a first line setting
Region
| Japan |
Condition
Condition
Non-small cell lung cancer
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To clarify the efficacy and safety of Pembrolizumab monotherapy as a first line setting for poor PS or elderly non-small cell lung cancer patients
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Progression-free survival of Pembrolizumab monotherapy
Key secondary outcomes
Overall survival, objective response rate, disease control rate, and disease-free survival of Pembrolizumab monotherapy
Incidence and grade of adverse events, including immune-related adverse events, with pembrolizumab monotherapy
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
| 20 | years-old | <= |
Age-upper limit
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
(1) Patients between 20 and 75 years of age with ECOG-performance status (PS) 2, or patients over 75 years of age with PS 0-2
(2) Patients with advanced or recurrent non-small cell lung cancer with positive intratumoral programmed death-ligand 1 expression
(3) Patients with evaluable lesions by RECIST(version.1.1)
(4) Patients who are scheduled to receive first-line treatment with pembrolizumab monotherapy
(5) Patients who have been fully informed of the contents of this clinical study and have given their free written consent
Key exclusion criteria
(1) Patients receiving concomitant treatment with other antineoplastic agents (cell-killing anticancer agents, molecular targeted agents, hormone therapy, other investigational agents, etc.)
(2)Patients with a history of treatment with other cancer drug therapies
(3)Patients who are eligible for treatment with platinum-based chemotherapy plus PD-1/PD-L1 inhibitor as initial systemic therapy
(4) Patients with EGFR mutation or ALK fusion gene
(5) Patients who are judged as inappropriate by the physician in charge
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Tadaaki |
| Middle name | |
| Last name | Yamada |
Organization
Kyoto Prefectural University of Medicine
Division name
Pulmonary Medicine
Zip code
6028566
Address
465, Kajii-cho, Kamigyo-ku, Kyoto
TEL
075-251-5513
tayamada@koto.kpu-m.ac.jp
Public contact
Name of contact person
| 1st name | Shinsuke |
| Middle name | |
| Last name | Shiotsu |
Organization
Japanese Red Cross Kyoto Daiichi Hospital
Division name
Clinical Oncology
Zip code
6050981
Address
15-749, Honmachi, Higashiyama-ku, Kyoto
TEL
075-561-1121
Homepage URL
sshiotsu@gmail.com
Sponsor or person
Institute
Kyoto Prefectural University of Medicine
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
1. Department of Respiratory Medicine, Uji-Tokushukai Medical Center, Kyoto, Japan
2. Department of Respiratory Medicine, Otsu City Hospital, Shiga, Japan
3. Department of Medical Oncology, Fukuchiyama City Hospital, Kyoto, Japan
4. Department of Respiratory Medicine, Japanese Red Cross Kyoto Daiichi Hospital, Kyoto, Japan
5. Department of Respiratory Medicine, Japanese Red Cross Kyoto Daini Hospital, Kyoto, Japan
6. Department of Respiratory Medicine, Matsushita Memorial Hospital, Moriguchi, Osaka
7. Department of Respiratory Medicine, Rakuwakai Otowa Hospital, Kyoto, Japan
8. Department of Respiratory Medicine, Kyoto Takeda Hospital, Kyoto, Japan
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Japanese Red Cross Kyoto Daiichi Hospital
Address
15-749, Honmachi, Higashiyama-ku, Kyoto
Tel
075-561-1121
sshiotsu@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
| 2021 | Year | 05 | Month | 07 | 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
40
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
Completed
Date of protocol fixation
| 2019 | Year | 04 | Month | 09 | Day |
Date of IRB
| 2019 | Year | 05 | Month | 21 | Day |
Anticipated trial start date
| 2019 | Year | 05 | Month | 22 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2021 | Year | 04 | Month | 27 | Day |
Last modified on
| 2023 | Year | 01 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050176
