UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Phase II study of continuation maintenance by use of nab-Paclitaxel and Bevacizumab after induction chemotherapy of Carboplatin and nab-Paclitaxel pulse bevacizumab in chemotherapy-naïve patients with Stage IIIB / IV non-squamous and non-small cell lung cancer.
Title of the study (Brief title)	Phase II of Carboplatin (CBDCA) and nab-Paclitaxel (nab-PTX) pulse bevacizumab (BEV) followed by nab-Paclitaxel and bevacizumab
Region	Japan

Condition
Condition	Non-small and non-squamous cell lung cancer
Classification by specialty	Pneumology Hematology and clinical oncology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate efficacy and safety of nab-PTX and BEV after induction by CBDCA and nab-PTX pulse BEV in chemotherapy-naïve patients with Stage IIIB / IV non-squamous and non-small cell lung cancer
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Explanatory
Developmental phase	Phase II

Assessment
Primary outcomes	Progression free survival (PFS) from the beginning of maintenance therapy
Key secondary outcomes	Response rate (RR) by RECIST, Disease control rate (DCR), Overall survival (OS), Time to treatment failure (TTF), maintenance rate, PFS from the start of induction therapy, Adverse events,

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	CBDCA and nab-PTX pulse BEV followed by nab-PTX pulse 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	Not applicable
Gender	Male and Female
Key inclusion criteria	I) Eligibility criteria for 1st registration 1) Histologically or cytologically proven non-squamous and non-small cell lung cancer 2) Stage IIIB/IV without indication for radical thoracic irradiation or recurrence after surgical treatment 3) Naive treatment of cytotoxic chemotherapy and recurrence more than 6 months ago after completion of postoperable adjuvant chemotherapy. OK432 pleurodesis for malignant pleural effusion is acceptable for pretreatment. 4)Eastern Cooperative Oncology Group performance status of 0-1 5)Age > or = 20 years 6) Tumor has the evaluable lesion. 7) Adequate organ function, Adequate organ function within 2 weeks a) Leukocyte count > or = 3,000/mm3 b) Neutrophil count > or = 1,500/mm3 c) Platelet count > or = 100,000/mm3 d) Hemoglobin concentration > or = 9.0 g/dl e) Total bilirubin level < or = 1.5 mg/dl f) Aspartate aminotransferase and alanine aminotransferase levels < or = 100 IU/L g) Serum creatinine levels < or = 1.5 mg/dl h) Acceptable cardiac function i) Peripheral neuropathy < or = grade 1 9) Estimating Survival more than 3 months 10)Written informed consent II) Eligibility Criteria for 2nd registration 1) More than 2 cycles of induction chemotherapy 2) Response criteria of induction chemotherapy achieved more than and equal to SD. 3) Recover within 6 weeks after start of last cycle of induction therapy. 1.PS 0-1 2.Leukocyte count > or = 3,000/mm3 3.Neutrophil count > or = 1,500/mm3 4.Platelet count > or = 100,000/mm3 5.Hemoglobin concentration > or = 8.0 g/dl 6.Total bilirubin level < or = 1.5 mg/dl 7.Aspartate aminotransferase and alanine aminotransferase levels < or = 100 IU/L 8.Serum creatinine levels < or = 1.5 mg/dl 9.Peripheral neuropathy < or = grade 2 10.Hypertension < or = grade 2 11.proteinuria < or = grade 2 12.any bleeding < or = grade 1 13.thromboembolic event absence
Key exclusion criteria	1) Patients with squamous cell lung cancer. 2) History of allergic reaction for agents of present treatment 3) Severe myelosupperssion, renal dysfunction or hepatic dysfunction 4) Active concomitant malignancy except carcinoma in situ, intra-mucosal carcinoma or cancer with more than 5 year disease free 5) Active infection more than and equal to grade 2 6) Massive pleural effusion, peritoneal effusion or cardiac effusion required for tube drainage 7) Patients required for continuing more than and equal to 10 mg/day of steroid therapy 8) A history of significant hemoptysis (> 2.5 mL red blood per episode) within 3 months before enrolment 9) History of thromboembolic events 10) Any history of cerebral, myocardial, and pulmonary infarction 11) Bleeding tendency, blood coagulation disorder 12) Other ineligible for bevacizumab 13) Pregnant status or lactation 14) Uncontrolled psychiatric disease 15) Other ineligible status judged by medical oncologist.
Target sample size	42

Research contact person
Name of lead principal investigator	Yuichiro Takeda
Organization	National Center for Global health and Medicine-Hospital
Division name	Department of Respiratory Medicine
Address	1-21-1 Toyama, Shinjuku-ku, Tokyo, 162-8655, Japan
TEL	03-3202-7181
Email	ytakeda@hosp.ncgm.go.jp

Public contact
Name of contact person	Yuichiro Takeda
Organization	National Center for Global health and Medicine-Hospital
Division name	Department of Respiratory Medicine
Address	1-21-1 Toyama, Shinjuku-ku, Tokyo, 162-8655, Japan
TEL	03-3202-7181
Homepage URL
Email	ytakeda@hosp.ncgm.go.jp

Sponsor
Institute	Department of Respiratory Medicine National Center for Global health and Medicine-Hospital
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization	None

Other related organizations
Co-sponsor	None
Name of secondary funｄer(s)	None

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	慶応義塾大学病院　呼吸器内科　(東京都） 災害医療センター　呼吸器内科　(東京都） 帝京大学医学部附属病院　呼吸器・アレルギー内科　(東京都） 東京医科大学病院　呼吸器・甲状腺外科　(東京都） 東京女子医科大学病院　呼吸器内科　(東京都） 虎の門病院　呼吸器センター内科　(東京都）　 国立国際医療研究センター　呼吸器内科　(東京都）

Other administrative information
Date of disclosure of the study information	2013 Year 12 Month 02 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2013 Year 09 Month 12 Day
Anticipated trial start date	2013 Year 12 Month 02 Day
Last follow-up date	2018 Year 06 Month 01 Day
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	Because of slow accrual, this study will not be capable of completion. The study committee decided termination of this study.
Other related information

Management information
Registered date	2013 Year 12 Month 01 Day
Last modified on	2018 Year 06 Month 10 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000014551