UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Phase II study of low-dose afatinib for elderly patients with non-small cell lung cancer harboring EGFR mutation (based on TDM)
Title of the study (Brief title)	Phase II study of low-dose afatinib for elderly NSCLC patients
Region	Japan

Condition
Condition	Non-small cell lung cancer
Classification by specialty	Pneumology Hematology and clinical oncology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the efficacy and safety of low dose afatinib (20mg/day) for elderly patients with non-small cell lung cancer harboring EGFR mutation
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Phase II

Assessment
Primary outcomes	Progression-free survival
Key secondary outcomes	Response rate, Overall survival, Incidence of adverse events, PK analysis

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	1) Treatment with afatinib at a dose of 20 mg daily (until PD). 2) At day 7-14 after the start of afatinib, samples for pharmacokinetc analyses will be obtained (9 points). 3) Afatinib were permitted to dose escalate, if patients did not experience Gr 1 diarrhea and Gr 1 anorexia with trough concentration of afatinib < 15 ng/mL at day 7-14.
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) Pathologically confirmation of non small cell lung cancer 2) Clinical stage IIIB, IV, or postoperative recurrence 3) With activating EGFR mutation (Deletion in exon 19 or L858R in exon 21) 4) ECOG performance status 0-2 5) No prior therapy of EGFR-TKI 6) Measurable lesions based on RECIST ver1.1 7) Adequate organ functions 8) Written informed consent
Key exclusion criteria	1) Interstitial lung disease 2) Receiving continuous systemic corticosteroid 3) During pregnancy or lactation 4) Psychological disorder difficult to participate in this clinical study
Target sample size	25

Research contact person
Name of lead principal investigator	Toshiaki Takahashi
Organization	Shizuoka Cancer Center
Division name	Division of Thoracic Oncology
Address	1007 Shimonagakubo, Nagaizumi-cho, Sunto-gun
TEL	055-989-5222
Email	t.takahashi@scchr.jp

Public contact
Name of contact person	Hirotsugu Kenmotsu
Organization	Shizuoka Cancer Center
Division name	Division of Thoracic Oncology
Address	1007 Shimonagakubo, Nagaizumi-cho, Sunto-gun
TEL	055-989-5222
Homepage URL
Email	h.kenmotsu@scchr.jp

Sponsor
Institute	Shizuoka Cancer Center
Institute
Department

Funding Source
Organization	Grants-in-Aid for Scientific Research
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor	Department of Clinical Pharmacokinetics and Pharmacodynamics, Keio University School of Medicine
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	静岡県立静岡がんセンター（静岡県）

Other administrative information
Date of disclosure of the study information	2016 Year 05 Month 10 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2016 Year 03 Month 30 Day
Anticipated trial start date	2016 Year 08 Month 04 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	2016 Year 05 Month 09 Day
Last modified on	2016 Year 08 Month 17 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025635