UMIN-CTR Clinical Trial

Basic information
Public title	A phase II study to evaluate efficacy and safety of Bevacizumab combined with Cisplatin and S-1 for Advanced Non-Squamous Non-Small-Cell Lung Cancer
Acronym	A phase II study of Bevacizumab combined with Cisplatin and S-1 for Advanced Non-Squamous Non-Small-Cell Lung Cancer (TCOG LC-1202)
Scientific Title	A phase II study to evaluate efficacy and safety of Bevacizumab combined with Cisplatin and S-1 for Advanced Non-Squamous Non-Small-Cell Lung Cancer
Scientific Title:Acronym	A phase II study of Bevacizumab combined with Cisplatin and S-1 for Advanced Non-Squamous Non-Small-Cell Lung Cancer (TCOG LC-1202)
Region	Japan

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

Objectives
Narrative objectives1	To evaluate the efficacy and safety of bevacizumab combined with Cisplatin and S-1 advanced non-squamous non-small cell lung cancer
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase	Phase II

Assessment
Primary outcomes	Progression Free Survival
Key secondary outcomes	Response Rate Overall Survival Waterfall Plot Analysis Safety Profile Quality of Life

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	Bevacizumb (15mg/kg day1) + Cislpatin (65mg/m2 day1) + S-1(80mg/m2 day1-14) q3weeks at a target 6cycles(at least 4cycles) followed by Bevacizumab (15mg/kg day1) + S-1(80mg/m2 alternate-day(Mon.Wed.Fri.Sun.)) q3weeks 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.Written IC 2.Patients aged 20-74 years 3.ECOG performance status 0-1 4.Excepted to live over 3 months after administration day 5.Histologically or cytologically confirmed non-squamous non-small-cell lung cancer 6.Stage III/IV or post-operative recurrent disease 7.No prior chemotherapy 8.Target lesion is measurable(RECISTver1.1) 9.Adequate organ function
Key exclusion criteria	1.Symptomatic brain metastases 2.history of active double cancer within 5 years 3.Current history of hemosputum or hemoptysis 4.Have possibly complication related to bleeding episode 5.Receiving anticoagulant drug (including Aspirin over 325mg/day) 6.Great vessel involvement 7.Have received radiation therapy to lesions of lung 8.Pleural effusion,peritoneal fluid, and pericardial fluid 9.Serious complications 10.Perforation of the digestive tract or history of the perforation of the digestive tract within the past one year 11.Uncontrollable Hypertension 12.Interstitial pneumonia or pulmonary fibrosis detectable on X ray 13.Proven or suspected infections diseases 14.Watery diarrhea or Chronic constipation 15.Under treatment by flucytosine 16.Hypersensitivity of Protocol agents 17.History of pregnancy or lactation and no intention to practice birth control 18.Patients whose participation in the trial is judged to be inappropriate by the attending doctor
Target sample size	39

Research contact person
Last name of lead principal investigator	1st name Middle name Last name Kaoru Kubota
Organization	Nippon Medical School Hospital
Division name	nternal Medicine, Division of Pulmonary Medicine, Division of Medical Oncology
Zip code
Address	1-1-5, Sendagi, Bunkyo-ku, Tokyo, Japan
TEL	03-3822-2131
Email	tcog-lc@tcog.jp

Public contact
1st name of contact person	1st name Middle name Last name TCOG LC OFFICE
Organization	The Tokyo cooperative oncology group
Division name	Clinical Study Promotion Agency
Zip code
Address	Toa-Bldg.4F, 2-1-18 Hamamatsu-cho Minato-ku Tokyo Japan
TEL	03-5401-5020
Homepage URL
Email	tcog-lc@tcog.jp

Sponsor
Institute	The Tokyo cooperative oncology group
Institute
Department

Funding Source
Organization	The Tokyo cooperative oncology group
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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

Other administrative information
Date of disclosure of the study information	2013 Year 02 Month 01 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 12 Month 12 Day
Date of IRB	2012 Year 12 Month 12 Day
Anticipated trial start date	2013 Year 01 Month 07 Day
Last follow-up date	2017 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded	2018 Year 12 Month 31 Day

Other
Other related information

Management information
Registered date	2012 Year 12 Month 04 Day
Last modified on	2019 Year 04 Month 20 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011130