UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031929 |
|---|---|
| Receipt number | R000036468 |
| Scientific Title | AZD9291 in EGFR exon 20 insertion mutations |
| Date of disclosure of the study information | 2018/06/01 |
| Last modified on | 2021/05/06 21:14:54 |
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Basic information
Public title
AZD9291 in EGFR exon 20 insertion mutations
Acronym
AEX20
Scientific Title
AZD9291 in EGFR exon 20 insertion mutations
Scientific Title:Acronym
AEX20
Region
| Japan |
Condition
Condition
Non-Small cell Lung Cancer harbouring EGFR exon 20 insertion mutations
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To determine the efficacy and safety of AZD9291 in NSCLC harbouring EGFR exon 20 insertion mutations.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase I,II
Assessment
Primary outcomes
response rate
Key secondary outcomes
progression free survival, PFS
overall survival
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
NO
Dynamic allocation
NO
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Simon's two stage design
Stage 1 (n=12)
Stage 2 (n=9)
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. Patient with 20 years or older
2. Patient with pathologically confirmed non-small cell lung cancer(NSCLC)
3. Patient with advanced or metastatic NSCLC harbouring with EGFR exon 20 insertion mutation. Patient with incurable NSCLC by operation or radiation therapy.
4. Patient with NSCLC previously treated with 1, 2 or 3 regimens chemotherapy.
5. Patient with ECOG-PS 0-1.
6. Patient with life expectancy of 12 weeks or more.
7. Patient who agreed to receive clinical testing necessary for this study.
8. Patient with measurable NSCLC by RECIST (ver 1.1) criteria
9. Patient with written informed consent.
Key exclusion criteria
1. Patient who was previously treated by AZD9291 or other EGFR-TKIs (gefitinib, erlotinib, afatinib).
2. Patient with NSCLC harboring other EGFR mutations (Exon 19 deletions, L858R, T790M, G719X, L861Q).
3. Patient who was previously treated by immuno-checkpoint inhibitors.
4. Patient with past history of other malignancies (not including carcinoma in situ) within five years from day of informed consent.
5. Patient who is under the treatment of medication of other trails. Patient who was treated by other trial medication within five years from informed consent.
6. Patient with uncontrollable hypertension.
7. Patient with uncontrollable diabetes mellitus.
8. Patient with active bleeding diathesis.
9. Patient with the following results at screening.
HBs antigen, HBs, HBc, HCV or HIV antibodies positive. (HBs positive and/or HBc positive subjectes can be included if HBs antigen is netagitve.)
10. Patient with active infectious disease.
11. Patient who take CYP3A4 inducing medication or supplements.
12. Patient with previous treatment related CTCAE grade 2 or higher toxicities.
13. Patient with symptomatic brain metastases.
14. Patient with interstitial lung disease (ILD), drug induced ILD or radiation pneumonitis treated by systemic steroid therapy. Patient with active ILD.
Etc.
Target sample size
21
Research contact person
Name of lead principal investigator
| 1st name | Kenzo |
| Middle name | |
| Last name | Soejima |
Organization
Keio University Hospital
Division name
Clinical and Translational Research Center
Zip code
160-8582
Address
Shinanomachi 35, Shinjuku-ku, Tokyo, 160-8582 Japan
TEL
03-5363-3286
ksoejima@cpnet.med.keio.ac.jp
Public contact
Name of contact person
| 1st name | Yoko |
| Middle name | |
| Last name | Ito |
Organization
Keio University Hospital
Division name
Clinical and Translational Research Center
Zip code
160-8582
Address
Shinanomachi 35, Shinjuku-ku, Tokyo, 160-8582 Japan
TEL
03-5315-4278
Homepage URL
pm-group@ctr.hosp.keio.ac.jp
Sponsor or person
Institute
Keio University
Institute
Department
Personal name
Funding Source
Organization
AstraZeneca plc
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Keio University Hospital Institutional Review Board
Address
Shinanomachi 35, Shinjuku-ku, Tokyo, 160-8582 Japan
Tel
03-5363-3848
Keio-chiken@adst.keio.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
慶應義塾大学病院/ Keio University Hospital
国立がん研究センター東病院/National Cancer Center Hospital East
北海道大学病院/Hokkaido University Hospital
金沢大学附属病院/Kanazawa University Hospital
名古屋大学医学部附属病院/Nagoya University Hospital
岡山大学病院/Okayama University Hospital
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 06 | 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
| 2017 | Year | 12 | Month | 28 | Day |
Date of IRB
| 2018 | Year | 01 | Month | 25 | Day |
Anticipated trial start date
| 2018 | Year | 08 | Month | 03 | Day |
Last follow-up date
| 2020 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2021 | Year | 04 | Month | 22 | Day |
Other
Other related information
Management information
Registered date
| 2018 | Year | 03 | Month | 27 | Day |
Last modified on
| 2021 | Year | 05 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036468
