UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Phase 2 prospective study of the efficacy of nab-paclitaxel, carboplatin and bevacizumab for the treatment of stage 3B/4 non-squamous cell and non-small cell lung cancer
Title of the study (Brief title)	Phase 2 study of nab-paclitaxel, carboplatin and bevacizumab for the treatment of non-squamous and non-small cell lung cancer
Region	Japan

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

Objectives
Narrative objectives1	To investigate efficacy and safety of the combination therapy, nab-paclitaxel, carboplatin and bevacizumab,in patients with non-squamous cell and non-small cell advanced lung cancer.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Progressin free survival after the first line chemotherapy, the combination of nab-paclitaxel, carboplatin and bevacizumab.
Key secondary outcomes	Overall survival,progressin free survival after the maintenance therapy, response rate, and safety

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	The combination therapy of nab-paclitaxel, carboplatin and 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)Non-squamous cell and non-small cell lung cancer 2)Stage 3B or 4 3) Evaluable lesions 4) 20~74 years old 5) PS 0~1 6) No severe organ dysfunction and laboratory data fulfill the standards. 7) Three months and more survival is expected. 8) Informed consent 9) One regimen of EGFR-TKI or ALK-TKI is permitted.
Key exclusion criteria	1) Brain metastasis accompnied by significant symptoms. 2) Hemoptysis 3) Allergy or hypersensitibity against the medicines in this trial or albumin. 4) Peripheral neuropathy (grade 2 or more) before the treatment. 5) Uncontrolled effusion. 6) Palliative radiation within 2 weeks. 7) Operation within 4 weeks. 8) Active double cancer 9) High body temperature (38 degrees Celsius and more). 10) Severe complications. 11) Anti-coagulation therapy 12) Pregnant woman 13) HBs antigen positive 14) The subjects whom the doctor excluded.
Target sample size	30

Research contact person
Name of lead principal investigator	Tamotsu Ishizuka
Organization	Faculty of Medical Sciences, University of Fukui
Division name	Third Department of Internal Medicine
Address	23-3 Matsuoka-Shimoaizuki, Eiheiji-cho, Yoshida-gun. Fukui 910-1193
TEL	0776-61-8355
Email	tamotsui@u-fukui.ac.jp

Public contact
Name of contact person	Tamotsu Ishizuka
Organization	Faculty of Medical Sciences, University of Fukui
Division name	Third Department of Internal Medicine
Address	23-3 Matsuoka-Shimoaizuki, Eiheiji-cho, Yoshida-gun, Fukui 910-1193
TEL	0776-61-8355
Homepage URL
Email	tamotsui@u-fukui.ac.jp

Sponsor
Institute	University of Fukui
Institute
Department

Funding Source
Organization	University of Fukui
Organization
Division
Category of Funding Organization	Other
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	福井大学医学部附属病院（福井県）

Other administrative information
Date of disclosure of the study information	2016 Year 11 Month 01 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2016 Year 10 Month 17 Day
Anticipated trial start date	2016 Year 11 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	2016 Year 10 Month 28 Day
Last modified on	2018 Year 04 Month 30 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000028266