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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000027338
Receipt No. R000031085
Scientific Title A prospective, phase II trial of low-dose afatinib monotherapy for patients with EGFR, mutation-positive, non-small cell lung cancer(TORG1632).
Date of disclosure of the study information 2017/05/15
Last modified on 2018/09/18

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Basic information
Public title A prospective, phase II trial of low-dose afatinib monotherapy for patients with EGFR, mutation-positive, non-small cell lung cancer(TORG1632).
Acronym Low-dose afatinib phase II study patients with EGFR Mutation-positive NSCLC(TORG1632)
Scientific Title A prospective, phase II trial of low-dose afatinib monotherapy for patients with EGFR, mutation-positive, non-small cell lung cancer(TORG1632).
Scientific Title:Acronym Low-dose afatinib phase II study patients with EGFR Mutation-positive NSCLC(TORG1632)
Region
Japan

Condition
Condition Non-small Cell Lung Cancer
Classification by specialty
Pneumology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To investigate the efficacy and safety of low dose afatinib in patients with EGFR-mutant NSCLC.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Progression Free Survival
Key secondary outcomes -Response rate
-Disease control rate
-One-year PFS rate
-Overall survival
-Time to treatment failure
-AE rate

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 is prescribed at 20mg/day daily
If SD or =<AE Grade1, this dose can be increased after 8 weeks of treatment, and repeated up to 50mg
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)Histologicaly or cytologically confirmed Stage IV or recurrent non-small cell lung cancer
2)Harboring sensitive EGFR mutation(Exon 19 deletion,L858R)
3)No prior chemotherapy and EGFR-TKI
4)Measurable disease for RECIST ver.1.1
5)Aged equal and more than 20 years old.
6)ECOG PS 0-2
7)Life expectancy: more than 3 months
8)Informed consent
9)Adequate organ functions judged by laboratory tests
i.ANC >= 1,500 mm3
ii.Hb >= 9.0g/dl
iii.PLT >= 75,000 mm3
iv.T-bil < 1.5 mg/dl
v.AST < 100 IU/L
vi.ALT< 100 IU/L
vii.SpO2 >= 93 %
Key exclusion criteria 1)Prior chemotherapy, GFR-TKI, biological drug and any investigational drug within 4 weeks.
2)Prior hormone therapy within 2 weeks.
3)Patients received radiotherapy for primary region and/or evaluable region.
4)Patients with major operation history within 4 weeks or planned during treatment period/
5) Patients with apparent interstitial pneumonia or pulmonary fibrosis on chest computed tomography
6)Symptomatic brain metastases
7)Uncontrolled complications
8)Treatment needed infection
9)Patients with hepatic cirrhosis or HIV
10)Patients with active double cancer less than 5 years
11)Patients with significant malabsorption syndrome
12)Pregnancy, breastfeeding or suspected of being pregnant
13)Patients who are considered to have difficulty in enrollment of this trial based on clinically important psychiatric reasons
14)Patients with a history of allergy for a component of afatinib
Target sample size 52

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kaoru Kubota
Organization Graduate School of Medicine, Nippon Medical School, Nihon Medical School Hospital
Division name Department of Pulmonary Medicine and Oncology
Zip code
Address Sendagi 1-1-5, Bunkyo, Tokyo
TEL 03-3822-2131
Email kkubota@nms.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Rintaro Noro
Organization Graduate School of Medicine, Nippon Medical School, Nihon Medical School Hospital
Division name Department of Pulmonary Medicine and Oncology
Zip code
Address Sendagi 1-1-5, Bunkyo, Tokyo
TEL 03-3822-2131
Homepage URL
Email r-noro@nms.ac.jp

Sponsor
Institute Thoracic Oncology Research Group
Institute
Department

Funding Source
Organization Thoracic Oncology Research Group
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2017 Year 05 Month 15 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 No longer recruiting
Date of protocol fixation
2017 Year 02 Month 17 Day
Date of IRB
Anticipated trial start date
2017 Year 05 Month 15 Day
Last follow-up date
2020 Year 02 Month 29 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 05 Month 14 Day
Last modified on
2018 Year 09 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031085

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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