UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Phase I study of afatinib + bevacizumab for advanced NSCLC with EGFR mutation
Title of the study (Brief title)	Phase I study of afatinib + bevacizumab for advanced NSCLC with EGFR mutation
Region	Japan

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

Objectives
Narrative objectives1	To investigate feasibility, maximum tolerated dose and recommended phase II dose of afatinib + bevacizumab therapy for non-small cell lung cancer patients with EGFR mutation.
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase	Phase I

Assessment
Primary outcomes	To conclude maximum tolerated dose and recommended phase II dose.
Key secondary outcomes

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	Combination therapy of afatinib + bevacizumab
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	75 years-old >
Gender	Male and Female
Key inclusion criteria	1)Histologically or cytologically proven non-small cell lung cancer 2)Harboring sensitive EGFR mutation 3)Stage IIIB, IV, relapse post operation and no indication for operation and curative irradiation 4)Having measurable disease for RECIST ver. 1.1 5)More than 20 years old and less than 75 years old 6)Performance status: 0-1 7)Life expectancy: over 90 days 8)Adequate organ functions 9)PaO2 >= 70torr or SpO2 >= 95% at room air 10)Written informed consent
Key exclusion criteria	1)Active double cancer 2)Interstitial pneumonitis on chest CT 3)Symptomatic brain metastases 4)Uncontrollable pleural effusion or pericardial effusion 5)Having hemoptysis 6)Having risk factor of bleeding 7)Gastrointestinal ulcer or past history of gastrointestinal perforation 8)Uncontrollable hyper tension 9)Active infectious disease 10)Receiving steroids or immunosuppressants 11)Receiving consecutive oxygen therapy 12)Inadequate period from open surgery 13)Planning open surgery 14)Pregnant or breastfeeding woman 15)History of severe allergy 16)Having other severe complications 17)Patients whose physicians considered as inappropriate for this clinical study
Target sample size	20

Research contact person
Name of lead principal investigator	Kazuhisa Takahashi
Organization	Juntendo University
Division name	Department of Respiratory Medicine
Address	3-1-3, Hongo, Bunkyo-ku, Tokyo, Japan
TEL	03-5802-1062
Email	kztakaha@juntendo.ac.jp

Public contact
Name of contact person	Ryo Ko, Takehito Shukuya
Organization	Juntendo University
Division name	Department of Respiratory Medicine
Address	3-1-3, Hongo, Bunkyo-ku, Tokyo, Japan
TEL	03-5802-1062
Homepage URL
Email	rkou@juntendo.ac.jp

Sponsor
Institute	Juntendo University
Institute
Department

Funding Source
Organization	Juntendo University
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

Other administrative information
Date of disclosure of the study information	2014 Year 12 Month 22 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 11 Month 08 Day
Anticipated trial start date	2015 Year 01 Month 05 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 22 Day
Last modified on	2018 Year 12 Month 25 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018636