UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Phase II study of Carboplatin + nab-Paclitaxel followed by nab-Paclitaxel with chemotherapy naive advanced Non- Small Cell Lung Cancer
Title of the study (Brief title)	Phase II study of Carboplatin + nab-Paclitaxel followed by nab-Paclitaxel with chemotherapy naive advanced Non- Small Cell Lung Cancer
Region	Japan

Condition
Condition	Chemotherapy naive non-small cell lung cancer
Classification by specialty	Pneumology
Classification by malignancy	Malignancy
Genomic information	YES

Objectives
Narrative objectives1	To evaluate the efficacy of nab-PTX+CBDCA followed by nab-PTX in patients with NSCLC.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase	Phase II

Assessment
Primary outcomes	Progression Free Survival
Key secondary outcomes

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 100mg/sqm D1,8,15 + CBDCA AUC 6 D1:q4week*4cycles nab-Paclitaxel 100mg/sqm D1,8,15:q4week until PD
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 proven diagnosis of NSCLC that is locally advanced or metastatic 2) Female or male, 20 years of age or older 3) ECOG performance status 2 to 4 4) At least 1 measurable tumor lesion as per RECIST v1.1 5) Chemotherapy-naive patients 6) Adequate organ function 7) Signed and dated informed consent
Key exclusion criteria	1) Active severe comorbidity disease. 2) Interstitial pneumonia or pulmonary fibrosis on chest CT scans. 3) Patients with symptomatic Brain metastases. 4) Active concomitant malignancy. 5) Active infectious disease. 6) Pregnant or breast-feeding females. 7) Unstable psychic disorder. 8) Accepted continuous use of steroid. 9) Inappropriate patients for this study judged by the physicians.
Target sample size	40

Research contact person
Name of lead principal investigator	Kentaro Watanabe
Organization	Fukuoka University School of Medicine
Division name	Respiratory Medicine
Address	7-45-1 Nanakuma, Jonanku, Fukuoka
TEL	092-801-1011
Email	uchino@fukuoka-u.ac.jp

Public contact
Name of contact person	Junji Uchino
Organization	Fukuoka University School of Medicine
Division name	Respiratory Medicine
Address	7-45-1 Nanakuma, Jonanku, Fukuoka
TEL	075-251-5513
Homepage URL
Email	uchino@koto.kpu-m.ac.jp

Sponsor
Institute	Fukuoka University School of Medicine
Institute
Department

Funding Source
Organization	Fukuoka University School of Medicine, Respiratory Medicine
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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

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 09 Month 13 Day

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2014 Year 08 Month 27 Day
Anticipated trial start date	2014 Year 08 Month 27 Day
Last follow-up date
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
Other related information

Management information
Registered date	2014 Year 09 Month 12 Day
Last modified on	2018 Year 01 Month 26 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017570