UMIN-CTR Clinical Trial

Basic information
Public title	Phase 1/2 study of triple combination chemotherapy with Carboplatin, nab-Paclitaxel, and Bevacizumab for chemotherapy-naïve stageIIIB/IV non- squamous non-small-cell lung cancer (TORG1424/OLCSG1402)
Acronym	CARboplatin, Nab-paclitaxel and AVAstin for non-small cell Lung cancer(CARNAVAL) (TORG1424/OLCSG1402)
Scientific Title	Phase 1/2 study of triple combination chemotherapy with Carboplatin, nab-Paclitaxel, and Bevacizumab for chemotherapy-naïve stageIIIB/IV non- squamous non-small-cell lung cancer (TORG1424/OLCSG1402)
Scientific Title:Acronym	CARboplatin, Nab-paclitaxel and AVAstin for non-small cell Lung cancer(CARNAVAL) (TORG1424/OLCSG1402)
Region	Japan

Condition
Condition	Advanced stage IIIB/IV non-squamous non-small cell lung cancer
Classification by specialty	Pneumology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To determine the recommended dose of nab-Paclitaxel + Carboplatin + Bevacizumab combination chemotherapy and to assess the efficacy and safety with recommended dose
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Phase I,II

Assessment
Primary outcomes	Phase 1:Decision of recommend dose and schedule Phase 2: Response Rate
Key secondary outcomes	Overall survival(OS) Progression-free survival(PFS) Safety

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	nab-Paclitaxel + Carboplatin + Bevacizmab
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) Histologically or cytologically confirmed non-squamous, non-small cell lung cancer 2) Stage IIIB or stage IV without any indications for radiotherapy 3) No prior chemotherapy 4) Non active EGFR and ALK mutations 5) Have measurable lesions 6) Aged >=20 at the time of registration 7) ECOG performance status 0-1 8) Adequate organ function 9) Estimated life expectancy at least 12 weeks 10) Written informed consent
Key exclusion criteria	1) Symptomatic brain metastasis. 2) Current history of hemoptysis. 3) History of hypersensitivity for therapeutic agent or albumin products 4) With grade2 or more neuropathy 5) Uncontrolled ascites, pleural effusion or cardiac effusion. 6) Within 2 weeks after palliative radiotherapy 7) Within 4 weeks after operation 8) Active double malignancies 9) Fever over 38C 10) serious medical complications 11) Receiving anticoagulant drug (325mg and less aspirin is possible) 12) Pregnancy, breastfeeding or suspected of being pregnant 13) HBs positive patient 14) Others judged by attending physician
Target sample size	55

Research contact person
Last name of lead principal investigator	1st name Middle name Last name Katsuyuki Kiura
Organization	Katsuyuki Kiura
Division name	Department of Allergy and Respiratory
Zip code
Address	2-5-1 Shikata-cho, Kita-ku, Okayama 700-8558
TEL	(086)223-7151
Email	kkiura@md.okayama-u.ac.jp

Public contact
1st name of contact person	1st name Middle name Last name Naoyuki Nogami
Organization	National Hospital Organization Shikoku Cancer Center
Division name	Department of thoracic oncology
Zip code
Address	160 Kou Minamiumemoto-machi, Matsuyama, Ehime 791-0280
TEL	(089)999-1111
Homepage URL	http://www.torg.or.jp/
Email	nnogami@shikoku-cc.go.jp

Sponsor
Institute	Thoracic Oncology Research Group
Institute
Department

Funding Source
Organization	Taiho Pharmaceutical CO., LTD
Organization
Division
Category of Funding Organization	Profit organization
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

Other administrative information
Date of disclosure of the study information	2014 Year 07 Month 30 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	2014 Year 06 Month 02 Day
Date of IRB	2014 Year 09 Month 22 Day
Anticipated trial start date	2014 Year 10 Month 09 Day
Last follow-up date	2019 Year 02 Month 28 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2014 Year 07 Month 15 Day
Last modified on	2019 Year 04 Month 24 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000016925