UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017877 |
|---|---|
| Receipt number | R000020713 |
| Scientific Title | First-line afatinib in patients aged 75 or older with advanced non-squamous non-small cell lung cancer harboring EGFR mutations; non-randomized phase II trial |
| Date of disclosure of the study information | 2015/08/01 |
| Last modified on | 2021/06/15 10:32:23 |
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Basic information
Public title
First-line afatinib in patients aged 75 or older with advanced non-squamous non-small cell lung cancer harboring EGFR mutations; non-randomized phase II trial
Acronym
First-line afatinib for elderly patients
Scientific Title
First-line afatinib in patients aged 75 or older with advanced non-squamous non-small cell lung cancer harboring EGFR mutations; non-randomized phase II trial
Scientific Title:Acronym
First-line afatinib for elderly patients
Region
| Japan |
Condition
Condition
patients aged 75 or older with advanced non-squamous non-small cell lung cancer harboring EGFR mutations
Classification by specialty
| Pneumology | Adult |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Data on efficacy and safety of afatinib for patients aged 75 years or older will be collected and evaluated.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
Overall Response Rate
Key secondary outcomes
Progression Free Survival
Time to Treatment Failure
Overall Survival
Disease Control Rate
1 and 2 Year Survival Rate
Adverse Event
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/1x
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
| 75 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Histologically or cytological confirmed stage III/IV non-small cell lung cancer
2. Patients having EGFR mutation (exon 19 deletion or L858R)
3. No prior chemotherapy and no prior treatment with EGFR targeting small molecules or antibodies.
4. Measurable lesion for RECIST(ver 1.1)
5. Patients aged 75 years or older
6. ECOG performance status 0 to1
7. Adequate organ function
8. Life expectancy more than three months
9. Written informed consent
Key exclusion criteria
1. Chemotherapy, biological therapy or investigational agents for other carcinomas within four weeks prior to the start of study treatment. Hormonal treatment within 2 weeks prior to start of study treatment
2. Previous radiotherapy to the primary tumor or mesurable lesion
3. Major surgery within 4 weeks before starting study treatment or scheduled for surgery during the projected course of the study
4. Patients with active lung disease such as interstitial pneumonia, active radiation pneumonitis, or drug-induced pneumonitis
5. Massive pleural or pericardial effusion, or ascites
6. Symptomatic brain metastases
7. Any history or presence of poorly controlled diseases that could affect the absorption of the study drug
8. Active infection, active hepatitis B infection, active hepatitis C infection and/or known HIV carrier.
9. Other concurrent active malignancy
10. Any history or presence of poorly controlled gastrointestinal disorders that could affect the absorption of the study drug
11. Pregnancy
12. Clinically significant phycological problem
13. Patients with uncontrollable complications
14. Known hypersensitivity to afatinib or the excipients of any of the trial drugs
Target sample size
35
Research contact person
Name of lead principal investigator
| 1st name | Akihiko |
| Middle name | |
| Last name | Gemma |
Organization
Graduate school of medicine, Nippon medical school
Division name
Department of pulmonary medicine and oncology
Zip code
113-8603
Address
1-1-5, Sendagi, Bunkyo-ku, Tokyo 113-8603, Japan
TEL
03-3822-2131
agemma@nms.ac.jp
Public contact
Name of contact person
| 1st name | Yuji |
| Middle name | |
| Last name | Minegishi |
Organization
Graduate school of medicine, Nippon medical school
Division name
Department of pulmonary medicine and oncology
Zip code
113-8603
Address
1-1-5, Sendagi, Bunkyo-ku, Tokyo 113-8603, Japan
TEL
03-3822-2131
Homepage URL
yminegis@nms.ac.jp
Sponsor or person
Institute
Non Profit Organization North East Japan Study Group
Institute
Department
Personal name
Funding Source
Organization
Nippon Boehringer Ingelheim Co., Ltd.
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
Nippon Medical School Hospital, Center for Clinical Research
Address
1-1-5, Sendagi, Bunkyo-ku, Tokyo 113-8603, Japan
Tel
03-3822-3131
app-ccr@nms.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
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 08 | 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
38
Results
Patients characteristics N=38 (SAS)
Gender:Male/Female 12/23
Age:median(range) 77 (75-91) years
Smoking status:Never 26(68.4%)
ECOG PS:0/1 21/17
EGFR mutation type:ex19del/L858R 23/15
Promary endpoint
Objective response rate:75.7% (95%CI 58.8-88.2%)
Secondary endpoint
Disease control rate:33% (74.6-97.0%)
Adverse event:
All garade 100%, grade3/4 63.2% Grade5 0%
Results date posted
| 2019 | Year | 06 | Month | 17 | Day |
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
| 2015 | Year | 05 | Month | 18 | Day |
Date of IRB
| 2015 | Year | 03 | Month | 27 | Day |
Anticipated trial start date
| 2015 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 06 | Month | 11 | Day |
Last modified on
| 2021 | Year | 06 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020713
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