UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034682 |
|---|---|
| Receipt number | R000039537 |
| Scientific Title | Observational study of osimertinib for patients with locally advanced/metastatic non-small cell lung cancer who are harboring T790M mutation detected by liquid biopsy and whose disease has progressed with previous EGFR-TKI therapy(WJOG8815LFS) |
| Date of disclosure of the study information | 2018/11/01 |
| Last modified on | 2021/10/08 17:05:45 |
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Basic information
Public title
Observational study of osimertinib for patients with locally advanced/metastatic non-small cell lung cancer who are harboring T790M mutation detected by liquid biopsy and whose disease has progressed with previous EGFR-TKI therapy(WJOG8815LFS)
Acronym
Observational study of osimertinib for patients with locally advanced/metastatic non-small cell lung cancer who are harboring T790M mutation detected and whose disease has progressed with previous EGFR-TKI therapy(WJOG8815LFS)
Scientific Title
Observational study of osimertinib for patients with locally advanced/metastatic non-small cell lung cancer who are harboring T790M mutation detected by liquid biopsy and whose disease has progressed with previous EGFR-TKI therapy(WJOG8815LFS)
Scientific Title:Acronym
Observational study of osimertinib for patients with locally advanced/metastatic non-small cell lung cancer who are harboring T790M mutation detected and whose disease has progressed with previous EGFR-TKI therapy(WJOG8815LFS)
Region
| Japan |
Condition
Condition
EGFR mutation positive advanced or metastatic NSCLC
Classification by specialty
| Pneumology | Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To investigate duration of response and overall survival of osimertinib therapy for patients with locally advanced/metastatic non-small cell lung cancer who are harboring T790M mutation detected and whose disease has progressed with previous EGFR-TKI therapy. In addition, the drug-resistance factors will be discussed as exploratory research.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Duration of Response, progression free survival (PFS), overall survival.
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
Patients who were enrolled into WJOG8815L study and will be alive at the end of WJOG8815L study. Written informed consent obtained from the above patient after a sufficient explanation about the study given before enrollment in the study.
Key exclusion criteria
-
Target sample size
33
Research contact person
Name of lead principal investigator
| 1st name | Kazuhiko |
| Middle name | |
| Last name | Nakagwa |
Organization
Kinki University, Faculty of Medicine
Division name
Department of Medical Oncology
Zip code
377-2
Address
Ohno-higashi, Osaka-Sayama, 589-8511, Japan
TEL
072-366-0221
nakagawa@med.kindai.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 556-0016 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
Kindai University Hospital
Address
Ohno-higashi, Osaka-Sayama, 589-8511, Japan
Tel
072-366-0221
zizen@med.kindai.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 | 11 | Month | 01 | 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
Completed
Date of protocol fixation
| 2018 | Year | 10 | Month | 06 | Day |
Date of IRB
| 2018 | Year | 12 | Month | 04 | Day |
Anticipated trial start date
| 2018 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Target patinets:
Patients who were enrolled into WJOG8815L study and will be alive at the end of WJOG8815L study. Written informed consent obtained from the above patient after a sufficient explanation about the study given before enrollment in the study.
Coolected Data:
- Durtation of response/PFS
- Overall survival
- Blood sample at PD
Management information
Registered date
| 2018 | Year | 10 | Month | 29 | Day |
Last modified on
| 2021 | Year | 10 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039537
