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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000016444
Receipt No. R000018275
Scientific Title A phase 2 study of first line low dose afatinib in advanced non-small-cell lung cancer patients with mutated epidermal growth factor receptor
Date of disclosure of the study information 2015/02/04
Last modified on 2019/03/26

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Basic information
Public title A phase 2 study of first line low dose afatinib in advanced non-small-cell lung cancer patients with mutated epidermal growth factor receptor
Acronym A phase 2 study of first line low dose afatinib in advanced non-small-cell lung cancer patients with mutated epidermal growth factor receptor
Scientific Title A phase 2 study of first line low dose afatinib in advanced non-small-cell lung cancer patients with mutated epidermal growth factor receptor
Scientific Title:Acronym A phase 2 study of first line low dose afatinib in advanced non-small-cell lung cancer patients with mutated epidermal growth factor receptor
Region
Japan

Condition
Condition Non-small cell lung cancer
Classification by specialty
Medicine in general Pneumology Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 To investigate the efficacy and safety of low dose afatinib in patients with EGFR-mutant NSCLC: Exon19 deletion or Exon 21 L858R mutation.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes Progression free survival
Key secondary outcomes Overall survival
Safety
Response 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 tolerated, this dose can be increased after 21 days of treatment.
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)Histological or cytological proven NSCLC
2)With sensitive EGFR mutation: Exon 19 deletion or Exon 21 L858R mutation
3)No indication for operation or radiation therapy
4)Chemotherapy-naive advanced or relapsed NSCLC
5)If after adjuvant or neoadjuvant chemotherapy: No molecular target drug
4 weeks after treatment without platinum agent
6)interval of radiation therapy: 1 weeks after thoracic RT
7)age: over 20
8)ECOG PS: 0-2
9)Adequate organ functions judged by laboratory tests
10)Life expectanancy: over 3 months
11)Written informed consent
Key exclusion criteria 1)obvious interstitial pneumonia or pulmonary fibrosis by chest CT
2)uncontrolled pleural or pericardial effusion
3)symptomatic brain metastasis
4)active multiple tumor
5)cannot take orally
6)obvious liver cirrhosis
7)clinically significant heart disease
8)infection which requires treatment
9)pregnancy
10)history of severe allergic reaction
11)anticontraceptive
12)inadequate patients whom physicians considered
Target sample size 45

Research contact person
Name of lead principal investigator
1st name Yoshioka
Middle name
Last name Hiroshige
Organization Kurashiki Central Hospital
Division name Department of Respiratory Medicine
Zip code 710-8602
Address 1-1-1, Miwa, Kurashiki, Okayama
TEL 086-422-0210
Email hirotin@kchnet.or.jp

Public contact
Name of contact person
1st name Toshihide
Middle name
Last name Yokoyama
Organization Kurashiki Central Hospital
Division name Department of Respiratory Medicine
Zip code 710-8602
Address 1-1-1, Miwa, Kurashiki, Okayama
TEL 086-422-0210
Homepage URL
Email ty14401@kchnet.or.jp

Sponsor
Institute Kyoto Thoracic Oncology Research Group (KTORG)
Institute
Department

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 Kurashiki Central Hospital
Address 1-1-1, Miwa, Kurashiki, Okayama
Tel 086-422-0210
Email igakuken@kchnet.or.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 02 Month 04 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
2015 Year 01 Month 29 Day
Date of IRB
2015 Year 01 Month 29 Day
Anticipated trial start date
2015 Year 02 Month 05 Day
Last follow-up date
2019 Year 03 Month 31 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 02 Month 04 Day
Last modified on
2019 Year 03 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018275

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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