UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015568 |
|---|---|
| Receipt number | R000018092 |
| Scientific Title | Phase II study of EGFR-TKI rechallenge with afatinib in advanced NSCLC patients haboring sensitive EGFR mutation without T790M |
| Date of disclosure of the study information | 2014/11/30 |
| Last modified on | 2019/02/10 09:31:00 |
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Basic information
Public title
Phase II study of EGFR-TKI rechallenge with afatinib in advanced NSCLC patients haboring sensitive EGFR mutation without T790M
Acronym
Phase II study of EGFR-TKI rechallenge with afatinib in advanced NSCLC patients haboring sensitive EGFR mutation without T790M
Scientific Title
Phase II study of EGFR-TKI rechallenge with afatinib in advanced NSCLC patients haboring sensitive EGFR mutation without T790M
Scientific Title:Acronym
Phase II study of EGFR-TKI rechallenge with afatinib in advanced NSCLC patients haboring sensitive EGFR mutation without T790M
Region
| Japan |
Condition
Condition
Non-small cell lung cancer
Classification by specialty
| Medicine in general | Pneumology | Hematology and clinical oncology |
| Adult |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To investigate the efficacy of EGFR-TKI rechallenge with afatinib in patients with advanced NSCLC haboring sensitive EGFR mutation without T790M
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Progression free survival
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
Afatinib 40mg/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)Histologically or cytologically proven NSCLC
2)EGFR mutation (exon19 deletion or L858R in exon 21) without T790M proven by rebiopsy after PD of prior therapy
3)Age: over 20
4)PS(ECOG): 0-1
5)Unresectable clinical stage IIIB/IV
6)Previously treated with EGFR-TKI (only 1 regimen) and lasted for more than 6 months
7)Previously treated with plutinum combination chemotherapy
8)After 3rd line therapy
9)Interval of radiation therapy: 4 weeks after thoracic RT and 1 week after non-thoracic RT
10)Measurable disease for RECIST
11)Adequate organ functions judged by laboratory tests
12)Life expectancy: over 3 months
13)Written informed consent
Key exclusion criteria
1)SCLC and sarcoma peoven by rebiopsy
2)Symptomatic brain metastases
3)Leptomeningeal carcinomatosis
4)Active double cancer
5)Severe allergic history
6)Pregnancy
7)Svere complication
8)Indicated for urgent RT
9)Allergic history for afatinib
10)Inadequate patients whom physitians considered
Target sample size
12
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Katsuyuki Kiura |
Organization
Okayama University Hospital
Division name
Department of Respiratory Medicine
Zip code
Address
2-5-1, Shikatacho, Okayama, Japan
TEL
086-223-7151
pgjj77o3@s.okayama-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Naohiro Oda |
Organization
Okayama University Hospital
Division name
Department of Respiratory Medicine
Zip code
Address
2-5-1, Shikatacho, Okayama, Japan
TEL
086-223-7151
Homepage URL
pgjj77o3@s.okayama-u.ac.jp
Sponsor or person
Institute
Okayama University Hospital
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
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
| 2014 | Year | 11 | Month | 30 | 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
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
Main results already published
Date of protocol fixation
| 2014 | Year | 11 | Month | 18 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 12 | Month | 01 | 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
| 2014 | Year | 10 | Month | 30 | Day |
Last modified on
| 2019 | Year | 02 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018092
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
