UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Phase II study of Pemetrexed and Bevacizumab in Performance status 2 patients with advanced non-squamous non-small cell lung cancer.
Title of the study (Brief title)	Phase II study of Pemetrexed and Bevacizumab in PS2 patients with advanced non-squamous non-small cell lung cancer.
Region	Japan

Condition
Condition	non-squamous non-small cell lung cancer
Classification by specialty	Medicine in general Hematology and clinical oncology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the response rate and feasibility of Pemetrexed and Bevacizumab in Performance status 2 patients with advanced non-squamous non-small cell lung cancer.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Phase II

Assessment
Primary outcomes	PFS
Key secondary outcomes	RR,DCR,OS,TTF,QOL,safety

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Pemetrexed and Bevacizumab administered every 3 week until observation of progression or intolerable toxicity.
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	1) StageIIIB/IV or postoperative recurrence Non-small cell lung cancer and Non-Squamous cell carcinoma proven by histology and/or cytology 2) EGFR mutation or ALK rearrangement status is not required 3) No prior chemotherapy 4) 20 years or older and PS 2 5) At least one or more measurable lesion by RECIST ver1.1 6) Adequate organ function 7) Interval -Palliative radiotherapy >4wks -Surgery >4wks -thoracic drainage>1wks -biopsy with dissection, indwelling port >1wks -blood transfusion >2wks 8) Life expectancy more than three months. 9) Written Informed Consent
Key exclusion criteria	1) History of hemoptysis 2) High risk of bleeding or thrombus events 3) History of anticoagulant within 10 days before enrollment 4) Active radiation pneumonitis or esophagitis 5) Uncontrollable hypertension 6) Symptomatic brain metastasis 7) Scheduled operation 8) Severe complications 9) Problematic infection 10) History of active double cancer 11) No intention to birth control 12) Unstable psychic disorder 13) History of treatment drug 14) Decision of ineligibility by a physician.
Target sample size	25

Research contact person
Name of lead principal investigator	Hirohisa Yoshizawa
Organization	Niigata University Medical and Dental Hospital
Division name	Bioscience Medical Research Center
Address	1-754 Asahimachi-Dori,Niigata City, Niigata 951-8520
TEL	025-227-2517
Email	hy0522@med.niigata-u.ac.jp

Public contact
Name of contact person	Hirohisa Yoshizawa
Organization	Niigata University Medical and Dental Hospital
Division name	Bioscience Medical Research Center
Address	1-754 Asahimachi-Dori,Niigata City, Niigata 951-8520
TEL	025-227-2517
Homepage URL
Email	hy0522@med.niigata-u.ac.jp

Sponsor
Institute	Niigata Lung Cancer Treatment Group
Institute
Department

Funding Source
Organization	Niigata Foundation for the Promotion of Medicine
Organization
Division
Category of Funding Organization	Non profit foundation
Nationality of Funding Organization	Japan

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	燕労災病院（新潟県） 厚生連長岡中央綜合病院（新潟県） 国立病院機構西新潟中央病院（新潟県） 済生会新潟第二病院（新潟県） 上越総合病院（新潟県） 新潟県立がんセンター（新潟県） 新潟県立吉田病院（新潟県） 新潟県立新発田病院（新潟県） 新潟県立中央病院（新潟県） 新潟市民病院（新潟県） 新潟大学医歯学総合病院（新潟県） 新潟労災病院（新潟県） 長岡赤十字病院（新潟県）

Other administrative information
Date of disclosure of the study information	2012 Year 06 Month 08 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2012 Year 03 Month 02 Day
Anticipated trial start date	2012 Year 06 Month 01 Day
Last follow-up date	2015 Year 06 Month 01 Day
Date of closure to data entry	2016 Year 06 Month 01 Day
Date trial data considered complete	2016 Year 10 Month 01 Day
Date analysis concluded	2016 Year 12 Month 01 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2012 Year 06 Month 08 Day
Last modified on	2018 Year 06 Month 14 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009565