UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025126 |
|---|---|
| Receipt number | R000028891 |
| Scientific Title | A biomarker analysis of Afatinib treatment in patients with relapse of EGFR-T790M mutation-positive advanced lung adenocarcinoma after 3rd generation EGFR-TKI treatment. |
| Date of disclosure of the study information | 2016/12/03 |
| Last modified on | 2016/12/02 14:57:52 |
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Basic information
Public title
A biomarker analysis of Afatinib treatment in patients with relapse of EGFR-T790M mutation-positive advanced lung adenocarcinoma after 3rd generation EGFR-TKI treatment.
Acronym
A biomarker analysis of Afatinib treatment in patients with relapse of EGFR-T790M mutation-positive advanced lung adenocarcinoma after 3rd generation EGFR-TKI treatment.
Scientific Title
A biomarker analysis of Afatinib treatment in patients with relapse of EGFR-T790M mutation-positive advanced lung adenocarcinoma after 3rd generation EGFR-TKI treatment.
Scientific Title:Acronym
A biomarker analysis of Afatinib treatment in patients with relapse of EGFR-T790M mutation-positive advanced lung adenocarcinoma after 3rd generation EGFR-TKI treatment.
Region
| Japan |
Condition
Condition
EGFR-T790M positive non-small-cell lung cancer relapsed after 3rd generation EGFR-TKI
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
The aim of this study is to investigate the utility of cell-free DNA for evaluating the mechanisms of resistance to 3rd generation EGFR-TKI, and the efficacy of afatinib treatment after relapsed 3rd generation EGFR-TKI
Basic objectives2
Others
Basic objectives -Others
Detection of drug resistance mechanisms to 3rd generation EGFR-TKI in plasma cell-free DNA
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Detection of biomarker for afatinib treatment in patients with relapse of EGFR-T790M mutation-positive advanced lung adenocarcinoma after 3rd generation EGFR-TKI treatment
Key secondary outcomes
progression free survival, response rate, 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
Consecutively administer oral dose of afatinib at 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)EGFR mutation-poasitive lung adenocarcinoma
2)T790M mutation was detected after EGFR-TKI treatment, and refractory to 3rd generation EGFR-TKI
3)Eastern Cooperative Oncology Group(ECOG) performance status of 0 to 2
4)with evaluable lesion based on RESIST
5)written informed consent
Key exclusion criteria
1) Active double cancer (simultaneous double cancer/multiple cancer, and metachronous double cancer/multiple cancer within 5 years of disease-free period. However, carcinoma in situ and a lesion equivalent to intramucosal carcinoma judged cured by local therapy are not included as active double cancer/multiple cancer).
2) Evidence of interstitial pneumonia or pulmonary fibrosis by chest CT scan.
3) Symptomatic brain metastasis (clinically stable brain metastasis is eligible)
4) HBs antigen-positive
5) Infection requiring systemic treatment
6) Patients who, in the opinion of the attending physician, are inappropriate for the study
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hidenobu Ishii |
Organization
Kurume University School of Medicine
Division name
Division of Respirology, Neurology, and Rheumatology, Department of Internal Medicine
Zip code
Address
67 Asahi-machi, Kurume, Fukuoka 830-0011, Japan
TEL
0942-31-7560
ishii_hidenobu@med.kurume-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hidenobu Ishii |
Organization
Kurume University School of Medicine
Division name
Division of Respirology, Neurology, and Rheumatology, Department of Internal Medicine
Zip code
Address
67 Asahi-machi, Kurume, Fukuoka 830-0011, Japan
TEL
0942-31-7560
Homepage URL
ishii_hidenobu@med.kurume-u.ac.jp
Sponsor or person
Institute
Kurume University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Boehringer Ingelheim
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
Address
Tel
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 | 12 | Month | 03 | 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
Open public recruiting
Date of protocol fixation
| 2016 | Year | 07 | Month | 09 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 07 | Month | 20 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 12 | Month | 02 | Day |
Last modified on
| 2016 | Year | 12 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028891
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