UMIN-CTR Clinical Trial

Basic information
Public title	A randomized Phase II Study of Bevacizumab in Combination with Docetaxel or S-1 as second line therapy in wild-type EGFR Patients with Non-Squamous Non-Small-Cell Lung Cancer. After failure to first line therapy, platinum doublet plus bevacizumab.
Acronym	A phase II study of A randomized phase II study of docetaxel plus bevacizumab vs S-1 plus bevacizumab as second line therapy for patients with NSCLC
Scientific Title	A randomized Phase II Study of Bevacizumab in Combination with Docetaxel or S-1 as second line therapy in wild-type EGFR Patients with Non-Squamous Non-Small-Cell Lung Cancer. After failure to first line therapy, platinum doublet plus bevacizumab.
Scientific Title:Acronym	A phase II study of A randomized phase II study of docetaxel plus bevacizumab vs S-1 plus bevacizumab as second line therapy for patients with NSCLC
Region	Japan

Condition
Condition	Non-Squamous Non-Small-Cell Lung Cancer
Classification by specialty	Pneumology Hematology and clinical oncology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	Efficacy and safety of Bevacizumab in Combination with Docetaxel or S-1 as second line therapy in wild-type EGFR Patients with Non-Squamous Non-Small-Cell Lung Cancer .After failure to first line therapy, platinum doublet plus bevacizumab.(A randomized Phase II Study)
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Phase II

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

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Historical
Stratification	YES
Dynamic allocation	YES
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Docetaxel(60mg/m2)day1 +Bevacizumab (15mg/kg) day 1 The treatment is repeated every three weeks until disease progression.
Interventions/Control_2	S-1 80mg-120mg/m2day1-day14 Bevacizumab 15mg/kg day1 The treatment is repeated every three weeks until disease progression.
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) written informed consent (2) It is judged by investigators to be treatable in this protocol (3) age>=20years (4) EGFR wild type mutation * as for the variation that EGFR-TKI does not have the sensitivity, registration is possible(T790M ,exon20 insertion etc) (5) histologically or cytologically proven non-squamous non-small cell lung cancer. after failure to first line therapy, platinum doublet plus bevacizumab * maintenance therapy to follow platinum doublet is regard as a series of first line therapy * EGFR-TKI(2nd-line erlotinib etc) is not regaed as the previous treatment * include a recurrence post-operation. in case of adjuvant chemotherapy, passing until first line therapy more than 6 months * palliative radiation therapy (gamma-knife, irradiation to a bone metastatic ) to any place other than the original lesion genesis can register if there is it more than 2 weeks after the radiation therapy(registration is possible from day 15 as day0 on last treatment day) (6) with measurable lesion(RECIST version 1.1) (7) radical radiation therapy cannot adapt (case of clinical stage of a disease IIIB, IV or recurrence post-operation) * using OK432 for hydrothorax control is possible (8) ECOG PS 0-1 (9) adequate organ function WBC >=4,000/mm3,<=12,000/mm3, Platelet >=100,000/mm3 ,Hb >=9.0 g/dl ,ALT,AST <=2.0 x the Upper Limits of Normal (ULN) (liver metastasis<=3.0 x ULN),T-bilirubin<=1.5 mg/dl , Serum creatinine 1.5 mg/dl ,CCr-60 ml/min, ECG(within normal limit) ,SpO2>=94% , Urine protein<= 1+ or 2 g in urine collection for 24h (10) life expectancy more than 3 months
Key exclusion criteria	(1) squamous metastasis (2) activating EGFR sensitive mutation or unknown(sensitive EGFR mutation:G719X, exon19deletion,L858R,L861Q) (3) having serious complications. ex): a serious heart disease , cerebrovascular disorder, diabetes that it is hard to control or hypertention , a severe infection, pulmonary fibrosis, interstitial pneumonia, respiratory failure, bleeding, a large quantity of hydrothorax or abdominal dropsy retention, peptic ulcer of the activity, serious nerve disease (4) symptomatic brain metastasis (5) have an anamnesis and the complications , expectoration of fresh blood more than 2.5 ml due to non-small-cell lung cancer (6) having an anamnesis of the following bloody phlegm or complications * there is the dosage career when bloody phlegm occurring continuously (more than one week) or the anamnesis or the internal use styptic is continuous(the cases that an internal use styptic was necessary for again after having been relieved using an internal use styptic or the bloody phlegm which needs with a history of bloody phlegm, the dosage of the injection styptic to need the dosage or the dosage) (7) current or previous (within the last 1 year) history of GI perforation (8) the operation has been scheduled for the examination period (9) have multiple primary cancer (10) history of serious drug hypersensitivity (11) pregnancy or lactation (12) active psychological disease (13) receives the steroid continuously(p.o. or i.v.) (14) any other medical condition that makes the patient unsuitable for inclusion in the study according to the opinion of the investigator.
Target sample size	60

Research contact person
Name of lead principal investigator	1st name Middle name Last name Koichi Takayama
Organization	Kyushu University, Graduate School of Medical Sciences
Division name	Research Institute for Diseases of the Chest
Zip code
Address	3-1-1 Maidashi, higashi-ku, Fukuoka, Japan , 812-8582
TEL	092-642-5378
Email

Public contact
Name of contact person	1st name Middle name Last name Taishi Harada
Organization	Kyushu University Hospital
Division name	respiratory division
Zip code
Address	3-1-1 Maidashi, higashi-ku, Fukuoka, Japan , 812-8582
TEL	092-642-5378
Homepage URL
Email	Harada-t@kokyu.med.kyushu-u.ac.jp

Sponsor
Institute	Lung Oncology Group in Kyushu, Japan (LOGIK)
Institute
Department

Funding Source
Organization	Clinical Research Support Center Kyushu
Organization
Division
Category of Funding Organization	Non profit foundation
Nationality of Funding Organization	JAPAN

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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	九州大学（福岡県） 国立病院機構九州医療センター（福岡県） 福岡赤十字病院（福岡県） 福岡大学（福岡県） 福岡大学筑紫病院（福岡県） 久留米大学（福岡県） 聖マリア病院（福岡県） 佐賀大学（佐賀県） 今給黎総合病院（鹿児島県）

Other administrative information
Date of disclosure of the study information	2012 Year 12 Month 21 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2012 Year 11 Month 12 Day
Date of IRB	2013 Year 02 Month 08 Day
Anticipated trial start date	2012 Year 11 Month 30 Day
Last follow-up date	2016 Year 10 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2012 Year 12 Month 21 Day
Last modified on	2021 Year 07 Month 06 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000011260