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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000034682
Receipt No. R000039537
Official scientific title of the study 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 2018/10/29

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Basic information
Official scientific title of the study 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)
Title of the study (Brief title) 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 Kazuhiko Nakagwa
Organization Kinki University, Faculty of Medicine
Division name Department of Medical Oncology
Address 377-2 Ohno-higashi, Osaka-Sayama, 589-8511, Japan
TEL 072-366-0221
Email nakagawa@med.kindai.ac.jp

Public contact
Name of contact person Shinichiro Nakamura
Organization West Japan Oncology Group
Division name WJOG datacenter
Address Namba Plaza Bldg. 304-1-5-7, Motomachi Naniwa-ku, Osaka 556-0016 JAPAN
TEL 06-6633-7400
Homepage URL
Email datacenter@wjog.jp

Sponsor
Institute West Japan Oncology Group
Institute
Department

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)

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

Progress
Recruitment status Preinitiation
Date of protocol fixation
2018 Year 10 Month 06 Day
Anticipated trial start date
2018 Year 12 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
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
2018 Year 10 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039537

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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