UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A Phase II Study of Cisplatin, Pemetrexed and Bevacizumab for Advanced Non-Small Cell (Non squamous cell) Lung Cancer
Title of the study (Brief title)	A Phase II Study of Cisplatin, Pemetrexed and Bevacizumab for Advanced Non-Small Cell (Non squamous cell) Lung Cancer
Region	Japan

Condition
Condition	Advanced Non-Small Cell (Non squamous cell) Lung Cance
Classification by specialty	Pneumology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To assess the safety and efficacy of Cisplatin Pemetrexed and Bevacizum in a phase II clinical study of patients with advanced non-small cell Lung cancer
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	ORR
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	CDDP+PEM+BEV
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 cytrologically confirmed diagnosis of NSCLC with a adeno or large cell carcinoma 2)No prior systemic treatment advanced NSCLC with documented Stage IIIB or Stage IV or recurrent disease 3)Tumors must have measurable disease by RECIST version 1.1 4)20 years of age or older to 75 years exclusive 5))ECOG performance status 0 or 1 6)No problem adequate organ function
Key exclusion criteria	1)Subjects with interstitial pneumonia or pulmonary fibrosis. 2)Uncontrolled Active infection 3)No other active malignancies 4)Concurrent use of steroid therapy 5)Subjects with symptomatic brain metastases. 6)have had or require continuous oral administration of hemostat/have had or require injectable administration of hemostat 7)Uncontrolled pleural. 8)Have received radiation therapy to lesions of lung 9)Have a bleeding diathesis 10)Uncontrolled hypertension 11)Any other reason that,in the opinion of the investugator precludes the subject from participating in the study.
Target sample size	45

Research contact person
Name of lead principal investigator	Makoto Nishio
Organization	Japanese Foundation for Cancer Research, the Cancer Institute Hospital
Division name	Thoracic Oncology Center
Address	3-8-31,Ariake, Koto-ku, Tokyo
TEL	03-3520-0111
Email	mnishio@jfcr.or.jp

Public contact
Name of contact person	Noriko Yanagitani
Organization	anese Foundation for Cancer Research, the Cancer Institute Hospital
Division name	Thoracic Oncology Center
Address	3-8-31,Ariake, Koto-ku, Tokyo
TEL	03-3520-0111
Homepage URL
Email	noriko.yanagitani@jfcr.or.jp

Sponsor
Institute	Japanese Foundation for Cancer Research, the Cancer Institute Hospital
Institute
Department

Funding Source
Organization	Japanese Foundation for Cancer Research, the Cancer Institute Hospital
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

Other administrative information
Date of disclosure of the study information	2011 Year 06 Month 13 Day

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2011 Year 04 Month 05 Day
Anticipated trial start date	2011 Year 06 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	2011 Year 06 Month 13 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=R000006702