UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037326 |
|---|---|
| Receipt number | R000042545 |
| Scientific Title | Biomarker study of a multicentre, open-label, randomized Phase III Study of Atezolizumab with Platinum-Pemetrexed with or without Bevacizumab for Patients with Advanced Non-Squamous Non-Small Cell Lung Cancer WJOG11218L/APPLE (APPLE Biomarker study) (WJOG11218LTR) |
| Date of disclosure of the study information | 2019/07/10 |
| Last modified on | 2021/01/11 08:52:47 |
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Basic information
Public title
Biomarker study of a multicentre, open-label, randomized Phase III Study of Atezolizumab with Platinum-Pemetrexed with or without Bevacizumab for Patients with Advanced Non-Squamous Non-Small Cell Lung Cancer WJOG11218L/APPLE (APPLE Biomarker study) (WJOG11218LTR)
Acronym
Apple biomarker study
Scientific Title
Biomarker study of a multicentre, open-label, randomized Phase III Study of Atezolizumab with Platinum-Pemetrexed with or without Bevacizumab for Patients with Advanced Non-Squamous Non-Small Cell Lung Cancer WJOG11218L/APPLE (APPLE Biomarker study) (WJOG11218LTR)
Scientific Title:Acronym
Apple biomarker study
Region
| Japan |
Condition
Condition
advanced non-squamous non-small cell lung cancer
Classification by specialty
| Pneumology | Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To elucidate patients whose value of VEGF-A and soluble PD-L1 in serum before treatment can be predictive of response to immunotherapies combined with an anti-antiogenesis antibody, Bevacizumab in a multicentre, open-label, randomized Phase III Study of Atezolizumab with Platinum-Pemetrexed with or without Bevacizumab for Patients with Advanced Non-Squamous Non-Small Cell Lung Cancer
Basic objectives2
Others
Basic objectives -Others
Exploration of biomarkers to predict response to platinum-combined immunotherapies
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Exploration of biomarkers to predict response to platinum-combined immunotherapies
Key secondary outcomes
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Subjects who agreed by consent forms to attend this study among those who attended WJOG 11218L.
Key exclusion criteria
Subjects who do not agree by consent forms to attend this study.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Isamu |
| Middle name | |
| Last name | Okamoto |
Organization
Kyushu University Hospital
Division name
Department of Respiratory Medicine
Zip code
812-8582
Address
Maidashi 3-1-1, Higashi-ku, Fukuoka
TEL
092-642-5378
iokamoto@kokyu.med.kyushu-u.ac.jp
Public contact
Name of contact person
| 1st name | Shinichiro |
| Middle name | |
| Last name | Nakamura |
Organization
West Japan Oncology Group
Division name
WJOG datacenter
Zip code
556-0016
Address
Namba Plaza Bldg. 304-1-5-7, Motomachi Naniwa-ku, Osaka, JAPAN
TEL
06-6633-7400
Homepage URL
datacenter@wjog.jp
Sponsor or person
Institute
West Japan Oncology Group
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
Kyushu University Institutional Review Board for Clinical Research
Address
Maidashi 3-1-1, Higashi-ku, Fukuoka
Tel
092-642-5774
bynintei@jimu.kyushu-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
| 2019 | Year | 07 | Month | 10 | 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
No longer recruiting
Date of protocol fixation
| 2019 | Year | 06 | Month | 28 | Day |
Date of IRB
| 2019 | Year | 09 | Month | 11 | Day |
Anticipated trial start date
| 2019 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 01 | Month | 19 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This is the observational study to collect blood once before treatment.
After August 2019, all patients are eligible who consented to attend this study by the document form among those who attended the WJOG11218L.
Management information
Registered date
| 2019 | Year | 07 | Month | 10 | Day |
Last modified on
| 2021 | Year | 01 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042545
| 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 |
