UMIN-CTR Clinical Trial

Basic information
Public title	Examination of the immunity and the blood clotting in patients with advancer non-small cell lung cancer treated with bevacizumab.Accompaniment research of TORG1321 study (UMIN000010681)
Acronym	Examination of the immunity and the blood clotting in patients with advancer non-small cell lung cancer treated with bevacizumab(TORG1321-S).
Scientific Title	Examination of the immunity and the blood clotting in patients with advancer non-small cell lung cancer treated with bevacizumab.Accompaniment research of TORG1321 study (UMIN000010681)
Scientific Title:Acronym	Examination of the immunity and the blood clotting in patients with advancer non-small cell lung cancer treated with bevacizumab(TORG1321-S).
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	Examination of the immunity in patients with advancer non-small cell lung cancer treated with bevacizumab. (The comparison of the immunity between patients with or without treatment of bevacizumab.)
Basic objectives2	PK,PD
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Examination of the immunity in patients entered TORG1321 study (UMIN000010681).
Key secondary outcomes	The comparison of the immunity between patients with or without treatment of bevacizumab.

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -but assessor(s) are blinded
Control	Active
Stratification	NO
Dynamic allocation	NO
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	CDDP 75mg/m2 + PEM 500mg/m2 + BEV 15mg/kg day 1 x 4 cycles q3wks followed byPEM 500mg/m2 q3wks until PD
Interventions/Control_2	CDDP 75mg/m2 + PEM 500mg/m2 + BEV 15mg/kg day 1 x 4 cycles q3wks followed byPEM 500mg/m2 BEV 15mg/kg q3wks until PD
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	First step(induction) 1)Histologically or cytologically proven non-squamous non-small cell lung cancer 2)Wild type EGFR 3)Stage IIIB,stageIV without any indications for radiotherapy 4)No prior chemotherapy 5)ECOG performance status 0-1 6)With one or more measurable disease (RECIST ver.1.1) 7) Aged 20<=, <=74 8)Adequate organ function 9)In case of non-chest radiation, need more than two weeks interval after last radiation 10)Written informed concent Second step (maintenance) 1)Non-PD patients after induction therapy 2)Adequate organ function after non-PD confirmation 3)ECOG performance status 0-1
Key exclusion criteria	First step(induction) 1)Symptomatic brain metastasis 2)Current history of hemoptysis 3)With pulmonary cavity lesions 4)History of radical thoracic radiotherapy 5)Active infections diseases 6)Fever over 38 degrees centigrade 7)Serious complications 8)Massive pleural and cardiac effusion and ascites that need to be immediately treated 9)Active concomitant cancers 10)Severe drug allergy 11)Uncontrollable ulcer indigestive tract 12)Perforation of the digestive tract or history within the past one year 13)Receiving anticoagulant drug (325mg and less aspirin is possible) 14) Pregnancy, breastfeeding or suspected of being pregnant 15)Those judged to be not suitable by the attending physician Second step (maintenance) 1)Symptomatic brain metastasis 2)Accompanied by serious complication in induction therapy 3) Severe drug allergy for PEM or BEM or severe adverse effect in induction therapy
Target sample size	30

Research contact person
Name of lead principal investigator	1st name Takashi Middle name Last name Kasai
Organization	Tochigi Cancer Center
Division name	Department of Medical Oncology, Division of Thoracic Oncology
Zip code	320-0834
Address	4-9-13, Yonan, Utsunomiya,Tochigi, Jaspan
TEL	+81-28-658-5151
Email	takasai@tochigi-cc.jp

Public contact
Name of contact person	1st name Takashi Middle name Last name Kasai
Organization	Tochigi Cancer Center
Division name	Department of Medical Oncology, Division of Thoracic Oncology
Zip code	320-0834
Address	4-9-13, Yonan, Utsunomiya,Tochigi, Jaspan
TEL	+81-28-658-5151
Homepage URL
Email	takasai@tochigi-cc.jp

Sponsor
Institute	Thoracic Oncology Research Group
Institute
Department

Funding Source
Organization	Thoracic Oncology Research Group
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Tochigi Cancer Center ethics committee
Address	4-9-13, Yonan, Utsunomiya,Tochigi, Jaspan
Tel	+81-45-534-4112
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	2018 Year 01 Month 16 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	8
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	2016 Year 05 Month 31 Day
Date of IRB	2016 Year 09 Month 14 Day
Anticipated trial start date	2016 Year 09 Month 15 Day
Last follow-up date	2021 Year 03 Month 31 Day
Date of closure to data entry	2021 Year 06 Month 30 Day
Date trial data considered complete	2021 Year 09 Month 30 Day
Date analysis concluded	2021 Year 12 Month 31 Day

Other
Other related information

Management information
Registered date	2018 Year 01 Month 16 Day
Last modified on	2021 Year 11 Month 08 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000035191