UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A Phase 2 Study of Bevacizumab in Combination with Carboplatin and Paclitaxel in Patients with Non-Squamous Non-Small-Cell Lung Cancer harboring Mutations of EGFR after failing First-line EGFR-TKIs
Title of the study (Brief title)	A Phase 2 Study of Bevacizumab in Combination with Carboplatin and Paclitaxel in Patients with Non-Squamous Non-Small-Cell Lung Cancer harboring Mutations of EGFR after failing First-line EGFR-TKIs
Region	Japan

Condition
Condition	Non-squamous Non-small-cell Lung Cancer
Classification by specialty	Pneumology
Classification by malignancy	Malignancy
Genomic information	YES

Objectives
Narrative objectives1	To evaluate the efficacy and safety of Bevacizumab in Combination with Carboplatin and Paclitaxel in Patients with Non-Squamous Non-Small-Cell Lung Cancer harboring Mutations of EGFR after failing First-line EGFR-TKIs
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Phase II

Assessment
Primary outcomes	Response rate
Key secondary outcomes	Overall survival Progression free survival Disease control rate Adverse events

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	Carboplatin AUC 5 or 6 day 1+Paclitaxel 200mg/m2 day 1+Bevacizumab 15 mg/kg day 1 q3w 3-6 cycles followed by Bevacizumab 15 mg/kg day 1 q3w until disease progression
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	74 years-old >=
Gender	Male and Female
Key inclusion criteria	1)Histologically or cytologically proven non-squamous non-small cell lung cancer 2)Non-squamous non-small cell lung cancer harboring mutations of EGFR patients with stage IIIB,stage IV (UICC-7) or recurrent disease after surgery,who have previously treated EGFR-TKIs 3)With measurable lesion(RECIST version 1.1) 4)More than 1 week after the last EGFR-TKIs 5)If the patient underwent therapy, there should be the following interval between the therapy and the registration i)Radiotherapy other than thoracic radiation ->1 week ii)Radiotherapy including pulmonary field ->3 months iii)Surgery(except CV-port reservation) ->4 weeks iv)Thoracic drainarge ->2 weeks v)Open biopsy, treatment of injury ->2 weeks vi)Aspiration biopsy, CV-port reservation ->1 week 6)Age: 20-74 years old 7)ECOG PS 0-1 8)Adequate organ function 9)Life expectancy more than 3 months 10)Written informed consent
Key exclusion criteria	1)Interstitial pneumonia or pulmonary fibrosis detectable on CT scan 2)History of drug induced interstitial pneumonia 3)History of severe drug allergy 4)History of active infection or other serious disease condition (GI bleeding,etc.) 5)History of poorly controlled pleural effusion,pericardial effusion and ascites 6)History of severe heart disease(uncontrollable arrythmia,uncontrollable angina pectoris,herat failure,etc.) 7)Uncontrollable hypertension 8)Uncontrollable diabetes mellitus 9)Current or previous history of hemoptysis or hemosputum 10)Current or previous (within the last 1 year) history of cerebrovascular disease 11)Current or previous (within the last 1 year) history of GI perforation 12)Symptomatic brain metastasis 13)Traumatic fracture of unrecovery 14)The operation has been scheduled for the examination period 15)Tumor invasive to the chest large blood vessel. Cavity in brain or lung tumor. 16)Evidence of bleeding diathesis or coagulopathy 17)Thrombosis that need to treat 18)History of active double cancer 19)History of active psychological disease 20)History of pregnancy or lactation
Target sample size	30

Research contact person
Name of lead principal investigator	Miyako Satouchi
Organization	Hyogo Cancer Center
Division name	Department of Thoracic Oncology
Address	13-70, Kitaouji-cho, Akashi, Hyogo 673-8558, Japan
TEL	078-929-1151
Email	satouchi@hp.pref.hyogo.jp

Public contact
Name of contact person	Yoshihiro Hattori
Organization	Hyogo Cancer Center
Division name	Department of Thoracic Oncology
Address	13-70, Kitaouji-cho, Akashi, Hyogo 673-8558, Japan
TEL	078-929-1151
Homepage URL
Email	hattori@hp.pref.hyogo.jp

Sponsor
Institute	Hanshin 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	大阪府立成人病センター（大阪府） 神戸大学医学部附属病院（兵庫県） 先端医療センター（兵庫県） 刀根山病院（大阪府） 兵庫県立がんセンター（兵庫県）

Other administrative information
Date of disclosure of the study information	2010 Year 02 Month 27 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2010 Year 01 Month 28 Day
Anticipated trial start date	2010 Year 03 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	Published
URL releasing results
Results
Other related information

Management information
Registered date	2010 Year 02 Month 27 Day
Last modified on	2018 Year 01 Month 05 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003953