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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000017877
Receipt No. 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 2019/06/17

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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
Email 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
Email yminegis@nms.ac.jp

Sponsor
Institute Non Profit Organization North East Japan Study Group
Institute
Department

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
Email 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 No longer recruiting
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
2019 Year 06 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020713

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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