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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000024218
Receipt No. R000027887
Scientific Title A phase II study of Osimertinib for untreated CNS metastasis, EGFR T790M-positive non-small cell lung cancer(LOGIK1603 / WJOG9116L)
Date of disclosure of the study information 2016/09/29
Last modified on 2021/11/24

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Basic information
Public title A phase II study of Osimertinib for untreated CNS metastasis, EGFR T790M-positive non-small cell lung cancer(LOGIK1603 / WJOG9116L)
Acronym A phase II study of osimertinib for untreated CNS metastasis, EGFR T790M-positive NSCLC(LOGIK1603 / WJOG9116L)
Scientific Title A phase II study of Osimertinib for untreated CNS metastasis, EGFR T790M-positive non-small cell lung cancer(LOGIK1603 / WJOG9116L)
Scientific Title:Acronym A phase II study of osimertinib for untreated CNS metastasis, EGFR T790M-positive NSCLC(LOGIK1603 / WJOG9116L)
Region
Japan

Condition
Condition EGFR-TKI treated T790M positive non-small cell lung cancer (NSCLC) with CNS metastasis (radiotherapy-naive)
Classification by specialty
Pneumology
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 We investigate efficacy and safety of osimertinib for patients with T790M positive non-small cell lung cancer (NSCLC) with CNS metastasis (radiotherapy-naive). We evaluate the correlation between anti-tumor effect of brain metastasis and plasma concentration (trough level in a steady state) of osimertinib. In exploratory analysis, we measure cerebrospinal fluid (CSF) penetration rate by measuring osimertinib concentration in CSF
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes Overall response rate (ORR) of metastatic brain tumor, progression free survival (PFS)
Key secondary outcomes ORR, ORR of metastatic brain tumor (evaluated according to RECIST ver. 1.1), PFS of metastatic brain tumor, overall survival (OS), safety

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 Osimertinib at the dose of 80mg/day is orally administered once daily and the administration is continued until progression disease (PD)
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 1) Patients with non-small-cell lung cancer (NSCLC) confirmed histologically or cytologically.
2) Patients with EGFR sensitive mutation (del19, L858R) detected in tumour tissue specimen or cytologic specimen.
3) Patients with treatment history of 1st generation and/or 2nd generation EGFR-TKI.
4) Patients with confirmation of EGFR T790M mutation positive after progression disease.
5) Patients with metastatic brain tumour (>= 5mm) with the major axis more than twice the slice width in MRI. However, patients required for urgent radiotherapy or surgical resection are ineligible.
6) Radiotherapy-naive for brain metastasis.
7) Patient is at least 20 years of age (at enrollment date).
8) Performance status (ECOG): 0-2
9) The latest clinical laboratory test within 14 days prior to enrollment (it is eligible on the same day 2 weeks before the enrolment day) meets the following all standard.
1.Neutrophil count >= 1,500/mm3
2.Haemoglobin >= 8.0g/dL
3.Platelet count >=100,000/mm3
4.AST, ALT <=100 IU/L
5.Total bilirubin <=1.5mg/dL
6.Creatinine<=1.5mg/dL
7.SpO2 >= 90%
10) Corrected QT interval (QTc) <= 470 msec.
11) Patients with life expectancy of at least 3 months.
12) Patients providing the written informed consent.
Key exclusion criteria 1) Symptomatic brain metastasis required for radiation therapy or surgical resection.
2) Patients with severe complication: such as myocardial infarction within 3 months, uncontrollable angina pectoris and heart failure
3) Patients with active double cancer (synchronous double cancer and asynchronous double cancer within 5 years of progression-free period. However, the lesions correspondent to carcinoma in situ and intramucosal carcinoma curable by topical treatment are excluded)
4) Treatment history of anti-PD-1 antibody, anti-PD-L1 antibody, anti- CD137 antibody or anti-CTLA-4 antibody.
5) Patients with pregnant or possibly pregnant.
6) Patients with nursing.
7) History of interstitial pulmonary disease, drug-induced interstitial pulmonary disease and irradiation pneumonitis required for steroidal treatment.
8) Urgent radiotherapy because of symptom of superior vena cava syndrome.
9) Patients who are different for the participation in the study by complication of mental disease or psychiatric symptom.
10) Any other patients who are regarded as unsuitable for this study by the investigators.
11) Patients with anamnesis of hypersensitivity to ingredients of the drug.
Target sample size 60

Research contact person
Name of lead principal investigator
1st name (1)Minoru (2)Hirotsugu
Middle name
Last name (1)Fukuda (2)Kenmotsu
Organization (1) Nagasaki University Hospital
(2) Shizuoka Cancer Center
Division name (1) Clinical Oncology Center (2) Division of Thoracic Oncology
Zip code 852-8501
Address (1) 1-7-1 Sakamoto, Nagasaki, Japan (2) 1007 Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka, Japan
TEL (1)095-819-7779(2)055-989-5222
Email mifukuda258@nifty.com

Public contact
Name of contact person
1st name (1) Hiroyuki (2) Kazushige
Middle name
Last name (1) Yamaguchi (2) Wakuda
Organization (1) Nagasaki University Hospital (2) Shizuoka Cancer Center
Division name (1) Department of Respiratory Medicine (2) Division of Thoracic Oncology
Zip code 852-8501
Address (1) 1-7-1 Sakamoto, Nagasaki, Japan (2) 1007 Shimonagakubo, Nagaizumi-cho, Suntogun, Shizuoka, Japan
TEL (1)095-819-7273(2)055-989-5222
Homepage URL
Email yamaguchi-hiroyuki@umin.ac.jp

Sponsor
Institute Clinical Research Support Center Kyushu
Institute
Department

Funding Source
Organization AstraZeneca K.K.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor (1)Lung Oncology Group in Kyushu (2) West Japan Oncology Group
Name of secondary funder(s)

IRB Contact (For public release)
Organization Clinical Research Network Fukuoka Certified Review Board
Address 3-1-1 Maidashi, Higashi-ku, Fukuoka, Fukuoka
Tel 092-643-7171
Email mail@crnfukuoka.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
2016 Year 09 Month 29 Day

Related information
URL releasing protocol
Publication of results Partially published

Result
URL related to results and publications
Number of participants that the trial has enrolled 66
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
2016 Year 09 Month 27 Day
Date of IRB
2016 Year 09 Month 27 Day
Anticipated trial start date
2016 Year 10 Month 16 Day
Last follow-up date
2022 Year 01 Month 22 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 09 Month 29 Day
Last modified on
2021 Year 11 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027887

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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