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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000031929
Receipt No. 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

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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
Email 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
Email pm-group@ctr.hosp.keio.ac.jp

Sponsor
Institute Keio University
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036468

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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