UMIN-CTR Clinical Trial

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
Last 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
1st 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