UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	To evaluate the efficacy and safety of Erlotinib and Bevacizumab in patients with advanced Non-squamous Non-Small Cell Lung Cancer with brain metastasis who acquired resistance to prior EGFR-TKI treatment harboring EGFR mutation.
Title of the study (Brief title)	To evaluate the efficacy and safety of Erlotinib and Bevacizumab in patients with advanced Non-squamous Non-Small Cell Lung Cancer with brain metastasis who acquired resistance to prior EGFR-TKI treatment harboring 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 evaluate the efficacy and safety of Erlotinib and Bevacizumab in patients with advanced Non-squamous Non-Small Cell Lung Cancer with brain metastasis who acquired resistance to prior EGFR-TKI treatment harboring EGFR mutation.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Phase II

Assessment
Primary outcomes	time to treatment failure after secondary enrollment
Key secondary outcomes	Toxicity Response Rate for intracranial metastases Overall survival

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	Erlotinib 150mg/day, oral daily Bevacizumab 15mg/kg, intravenous q3w
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	first enrollment 1)Histologically or cytologically confirmed non-squamous NSCLC 2)StageIIIB/IV or postoperative recurrence NSCLC 3)EGFR mutation(exon18,19,21) positive 4)EGFR-TKI treatment or plan treatment 5)Age>=20years 6)Patients without previous treatment for lung cancer A patient who has received postoperative chemotherapy is eligible if the last administration of the prior adjuvant regimen occurred at least 12 months 7)ECOG PS 0-2 8)Written informed consent from the patients. second enrollment 1)metastasis to brain during EGFR-TKI treatment 2)best effect that was higher than SD was accepted in EGFR-TKI monotherapy 3)Adequate function of main organ evaluated within enrollment as WBC=3,000~12000/mm3 Neu>=1,500/mm3 Plt>=10.0x10000/mm3 hemoglobin >=8.5g/dL AST,ALT=<2.5xULN T-bil=<2.0mg/dL Cr>=2.0xULN Proteinuria<1+ SpO2>=90%
Key exclusion criteria	first enrollment 1)Squamous cell carcinoma 2)brain metastasis 3)Pregnant or breast-feeding females second enrollment 1)Interstitial pneumonia or pulmonary fibrosis on chest CT scans 2)History of EGFR-TKI, VEGF antibody allergic reaction. 3)Radiotherapy enforcement example for the brain 4)Brain metastasis expected bleeding 5)Active severe comorbidity disease. 6)History of hemoptysis 7)Uncontrollable hypertension 8)History of gastrointenstinal perforation or diverticulitis or fistula 9)Scheduled operation 10)Active concomitant malignancy 11)Pregnant or breast-feeding females 12)Inappropriate patients for this study judged by the physicians
Target sample size	16

Research contact person
Name of lead principal investigator	Sho Saeki
Organization	Kumamoto University Hospital
Division name	Department of Respiratory Medicine
Address	1-1-1 Honjo,Chuo-ku,Kumamoto city,Kumamoto,Japan
TEL	096-373-5012
Email	saeshow@wg7.so-net.ne.jp

Public contact
Name of contact person	Sho Saeki
Organization	Kumamoto University Hospital
Division name	Department of Respiratory Medicine
Address	1-1-1 Honjo,Chuo-ku,Kumamoto city,Kumamoto,Japan
TEL	096-373-5012
Homepage URL
Email	saeshow@wg7.so-net.ne.jp

Sponsor
Institute	Department of Respiratory Medicine, Kumamoto University Hospital
Institute
Department

Funding Source
Organization	Kumamoto University Hospital
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	2013 Year 12 Month 09 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2013 Year 10 Month 01 Day
Anticipated trial start date	2013 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	2013 Year 12 Month 07 Day
Last modified on	2017 Year 12 Month 11 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000014649