UMIN-CTR Clinical Trial

Basic information
Public title	First-Line Afatinib in Patients Aged 75 or Older With Advanced Non-Small Cell Lung Cancer Harboring EGFR Mutation -Multicenter study on the Pharmacokinetics and pharmacogenetics of Afatinib-
Acronym	First-Line Afatinib in Patients Aged 75 or Older
Scientific Title	First-Line Afatinib in Patients Aged 75 or Older With Advanced Non-Small Cell Lung Cancer Harboring EGFR Mutation -Multicenter study on the Pharmacokinetics and pharmacogenetics of Afatinib-
Scientific Title:Acronym	First-Line Afatinib in Patients Aged 75 or Older
Region	Japan

Condition
Condition	patients aged 75 or older with advanced non small cell lung cancer harboring EGFR mutation
Classification by specialty	Pneumology
Classification by malignancy	Malignancy
Genomic information	YES

Objectives
Narrative objectives1	To evaluate the efficacy and safty of afatinib in patients aged 75 or older with advanced non small cell lung cancer harboring EGFR mutation
Basic objectives2	PK,PD
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase	Phase II

Assessment
Primary outcomes	response rate
Key secondary outcomes	disease control rate progression free survival overall survival Adverse events Quality of life PK/PGx

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
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)Histlogically or cytologically confirmed EGFR mutation positive non small cell lung cancer(NSCLC) 2)Unresectable and metastatic NSCLC 3)Harboring sensitive EGFR mutation 4)Patients who have never treated with EGFR-TKI and cytotoxic chemotherapy. 5)More than 75 years old 6)Performance Status (ECOG) 0-1 7)Measurable lesion for RECIST(version 1.1) 8)Adequate organ functions 9)Life expectancy over 3 months 10)Written informed consent
Key exclusion criteria	1)Concomitant treatment with other anticancer agent, radiotherapy, or immunotherapy. 2)Preexisting interstitial lung disease of chest CT 3)HBs antigen positive 4)HBs or HBc antibody positive, and HBV-DNA positive 5)EGFR minor mutation or exon 20 T790M 6)Active double cancer 7)Digestive disease influencing absorption of afatinib 8)Oral feeding difficulty 9)Patients whose attending doctor consider as inappropriate for this study
Target sample size	35

Research contact person
Last name of lead principal investigator	1st name Middle name Last name Oizumi Satoshi
Organization	Hokkaido Cancer Center
Division name	Respiratory Medicine
Zip code
Address	Kikusui4, West 2, Shiroishi-ku, Sapporo
TEL	011-811-9111
Email	soizumi@sap-cc.go.jp

Public contact
1st name of contact person	1st name Middle name Last name Hidenori Mizugaki
Organization	Hokkaido University Hospital
Division name	First department of medicine
Zip code
Address	North 14, West 5, Kita-ku, Sapporo
TEL	011-706-5911
Homepage URL
Email	mhide@med.hokudai.ac.jp

Sponsor
Institute	Hokkaido University Hospital, First department of medicine
Institute
Department

Funding Source
Organization	Cancer Fundation
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor	National Cancer Center
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	2015 Year 04 Month 10 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 03 Month 04 Day
Date of IRB	2015 Year 07 Month 14 Day
Anticipated trial start date	2015 Year 07 Month 15 Day
Last follow-up date	2019 Year 02 Month 28 Day
Date of closure to data entry
Date trial data considered complete	2019 Year 07 Month 31 Day
Date analysis concluded

Other
Other related information

Management information
Registered date	2015 Year 04 Month 05 Day
Last modified on	2019 Year 04 Month 08 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000019762