UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020688 |
|---|---|
| Receipt number | R000023822 |
| Scientific Title | Phase 2 study of low-dose Afatinib maintenance therapy for patients with EGFR-mutated non-small-cell lung cancer |
| Date of disclosure of the study information | 2016/01/25 |
| Last modified on | 2019/02/12 21:16:41 |
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Basic information
Public title
Phase 2 study of low-dose Afatinib maintenance therapy for patients with EGFR-mutated non-small-cell lung cancer
Acronym
Phase 2 study of low-dose Afatinib maintenance therapy for patients with EGFR-mutated non-small-cell lung cancer
Scientific Title
Phase 2 study of low-dose Afatinib maintenance therapy for patients with EGFR-mutated non-small-cell lung cancer
Scientific Title:Acronym
Phase 2 study of low-dose Afatinib maintenance therapy for patients with EGFR-mutated non-small-cell lung cancer
Region
| Japan |
Condition
Condition
EGFR-mutated non-small-cell lung cancer
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate efficacy and safety of low-dose affatinib maintenance therapy with aggressive reduction in patients with EGFR-mutated non-small-cell lung cancer.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
1-year progressive free survival rate
Key secondary outcomes
progresson free survival
response rate
incidence of adverse event
incidence of adverse event of grade 3 or more
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
Afatinib 40mg is administered by internal use once a day. When a prescriptive adverse event appeared, reduce the affatinib dose in 30mg from 40mg.Still when admitting a presscriptive adverse event, reduce the affatinib dose in 20mg from 30mg.
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 confirmed non-small cell lung cancer
2. clinical stage IIIB or IV or postoperative recurrence
3. admitted EGFR gene mutation except for T790M or exon20 insertion
4. No prior EGFR-TKI therapy
5. Prior therapy of platinum-combined chemotherapy within one regimen is permitted (postoperative adjuvant chemotherapy is not included)
6. Prior therapy of immuno-checkpoint inhibitor within one regimen is permitted
7. with measurable lesion
8. ECOG PS 0-2
9. lifeexpectancy of at least 3 months
10. with ritten informed consent
11. with adequate organ function
Key exclusion criteria
1. previously treated by EGFR-TKI
2. admitted EGFR gene mutation of T790M or exon20 insertion
3. symptomatic brain metastasis
4. with interstitial pneumonia or pulmonary fibrosis
5. with active other malignancies
6. with massive effusion required tube drainage
7. with active infection
8. with severe comorbidities
9. with other conditions that is considered inappropriate for the study by an attending physician
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shunichi Sugawara |
Organization
Sendai Kousei Hospital
Division name
department of respiratory medicine
Zip code
Address
4-15, Hirosemachi, Aobaku, Sendai, Miyagi, Japan, 980-0873
TEL
022-222-6181
swara357@cat-v.ne.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Akira Inoue |
Organization
North Japan Lung Cancer Study Group
Division name
office
Zip code
Address
1-1, Seiryoumachi, Aobaku, Sendai, Miyagi, Japan
TEL
022-717-8539
Homepage URL
akinoue@idac.tohoku.ac.jp
Sponsor or person
Institute
North Japan Lung Cancer Study Group
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
| 2016 | Year | 01 | Month | 25 | 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
| 2016 | Year | 01 | Month | 21 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 01 | Month | 26 | Day |
Last follow-up date
| 2018 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2018 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2018 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2019 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 01 | Month | 21 | Day |
Last modified on
| 2019 | Year | 02 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023822
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| Registered date | File name |
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