UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023823 |
|---|---|
| Receipt number | R000027447 |
| Scientific Title | Osimertinib in pre-treated poor PS patients with T790M-positive advanced NSCLC |
| Date of disclosure of the study information | 2016/11/01 |
| Last modified on | 2022/03/04 09:35:53 |
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Basic information
Public title
Osimertinib in pre-treated poor PS patients with T790M-positive advanced NSCLC
Acronym
Osimertinib in poor PS patients with T790M-positive advanced NSCLC
Scientific Title
Osimertinib in pre-treated poor PS patients with T790M-positive advanced NSCLC
Scientific Title:Acronym
Osimertinib in poor PS patients with T790M-positive advanced NSCLC
Region
| Japan |
Condition
Condition
Non-small cell lung cancer
Classification by specialty
| Pneumology | Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and safety of osimertinib in poor PS NSCLC.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
Response rate
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Osimertinib 80 or 40 mg/day
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) Pathologically or cytologically diagnosedadvanced non-small-cell lung cancer
2) Harboring EGFR active mutaion
3) Radiological progression was confirmed after 1st or 2nd generation EGFR-TKI
4) T790M mutation was confirmed
5) 5th or more days from the last dosage of EGFR-TKI
6) Age over 20 years old
7) ECOG PS 2-4
8) With evaluable lesion
9) Major organ function is satisfaction on registration in date from 14 days
10) Written informed consent
Key exclusion criteria
1) Patients with active double cancer for 5years
2) Interstitial pneumonia
3) Poor oral intake
4) History of using immunocheckpoint therapy
5) History of taking osimertinib medication
6) The infection requiring systemic treatment
7) Patients with psychosis or psychotic symptoms is determined to be difficult to participants in a clinical trial
8) Patients with symptomatic brain metastases
9) Uncontrolled diabetes
10) Serious complications
11) Patients during systemic administration steroids therapy over 4weeks
12) Poor PS due to complication
13) A pregnant woman, a woman in breast-feeding
14-15) Patients with severe heart disease
16) Prior radiotherapy for primary or metastasis evaluable lesion
17) Patients with severe hypersensitivity
18) Patients with corneal ulcer
19) An inappropriate case judged by doctor in charge
Target sample size
32
Research contact person
Name of lead principal investigator
| 1st name | Takeshi |
| Middle name | |
| Last name | Isobe |
Organization
Shimane University Faculty of Medicine
Division name
Department of Internal Medicine Division of Medical Oncology & Respiratory Medicine
Zip code
693-8501
Address
89-1 Enya-cho, Izumo, Shimane
TEL
0853-20-2580
isobeti@med.shimane-u.ac.jp
Public contact
Name of contact person
| 1st name | Yukari |
| Middle name | |
| Last name | Tsubata |
Organization
Shimane University Faculty of Medicine
Division name
Department of Internal Medicine Division of Medical Oncology & Respiratory Medicine
Zip code
693-8501
Address
89-1 Enya-cho, Izumo, Shimane
TEL
0853-20-2580
Homepage URL
ytsubata@med.shimane-u.ac.jp
Sponsor or person
Institute
North East Japan Study Group (NEJSG)
Institute
Department
Personal name
Funding Source
Organization
Astra Zeneca
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Medical Research Ethics Committee, Shimane University Faculty of Medicine
Address
89-1 Enya-cho, Izumo, Shimane
Tel
0853-20-2515
kenkyu@med.shimane-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
| 2016 | Year | 11 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
33
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
| 2016 | Year | 08 | Month | 14 | Day |
Date of IRB
| 2016 | Year | 09 | Month | 26 | Day |
Anticipated trial start date
| 2016 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2022 | Year | 09 | Month | 30 | Day |
Date trial data considered complete
| 2022 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2023 | Year | 04 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 08 | Month | 29 | Day |
Last modified on
| 2022 | Year | 03 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027447
