UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024218 |
|---|---|
| Receipt number | 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 13:23:23 |
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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
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
yamaguchi-hiroyuki@umin.ac.jp
Sponsor or person
Institute
Clinical Research Support Center Kyushu
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027887
