UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Phase II Study of First-Line Afatinib in Patients Aged 75 or Older With Advanced Lung Adenocarcinoma With EGFR Mutations
Title of the study (Brief title)	Phase II Study of Afatinib in Elderly Patients
Region	Japan

Condition
Condition	Elderly patients with NSCLC harboring sensitive EGFR mutation
Classification by specialty	Hematology and clinical oncology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the efficacy and safety of afatinib as a first line therapy in elderly patients with NSCLC harboring sensitive EGFR mutation
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Phase II

Assessment
Primary outcomes	PFS: progression free survival
Key secondary outcomes	RR: response rate OS: overall survival DCR: disease control rate AE: Adverse events

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Afatinib(30mg)/day p.o.
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	100 years-old >
Gender	Male and Female
Key inclusion criteria	1) Histologically or cytologically proven lung adenocarcinoma. 2) Harboring mutations of EGFR. 3) Stage III, IV 4) Chemothrapy naive patients 5) Performance Status(ECOG Scale): 0-2. 6) Adequate organ function 7) Life expectancy more than 12 weeks. 8) Written informed consent.
Key exclusion criteria	1) Interstitial pneumonia/lung fibrosis on chest CT. 2) Previous drug allergy 3) History of poorly controlled pleural effusion, pericardial effusion and ascites. 4) Active infection. 5) Current Diarrhea. 6) Ileus or intestinal tract paralysis. 7) Symptomatic brain metastasis. 8) Active concomitant malignancy. 9) History of sever heart disease. 10) History of sever psychological disease. 11) Those judged to be not suitable by the attending physician.
Target sample size	38

Research contact person
Name of lead principal investigator	Tomoya Kawaguchi
Organization	Graduate School of Medicine, Osaka City University
Division name	Department of Respiratory Medicine
Address	1-4-3, Asahi-machi, Abeno-ku, Osaka 545-8585, Japan
TEL	0666453793
Email	i-gakumu@med.osaka-cu.ac.jp

Public contact
Name of contact person	Naruo Yoshimura
Organization	Graduate School of Medicine, Osaka City University
Division name	Department of Respiratory Medicine
Address	1-4-3, Asahi-machi, Abeno-ku, Osaka 545-8585, Japan
TEL	0666453793
Homepage URL
Email	y-naruo@sc4.so-net.ne.jp

Sponsor
Institute	Osaka Lung Cancer Study Group
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)

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	大阪市立大学医学部附属病院（大阪府）、大阪市立総合医療センター（大阪府）、関西医大病院（大阪府）、石切生喜病院（大阪府）、淀川キリスト教病院（大阪府）、ベルランド病院（大阪府）、JR大阪鉄道病院（大阪府）

Other administrative information
Date of disclosure of the study information	2014 Year 12 Month 03 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2014 Year 11 Month 02 Day
Anticipated trial start date	2014 Year 12 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2014 Year 12 Month 03 Day
Last modified on	2019 Year 02 Month 21 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000018426