UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A phase 2 trial of weekly nab-paclitaxel for advanced non-small cell lung cancer without EGFR mutation nor ALK fusion gene in salvage setting
Title of the study (Brief title)	NICE Salvage study
Region	Japan

Condition
Condition	Advanced non-small cell lung cancer without EGFR mutation nor ALK fusion gene
Classification by specialty	Medicine in general Pneumology Hematology and clinical oncology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the efficacy and safety of weekly nab-PTX therapy for advanced Non-small cell lung cancer patients in salvage setting.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Phase II

Assessment
Primary outcomes	Progression Free Survival
Key secondary outcomes	Overall Survival, Response Rate, Adverse event, Quality of life, Difference in efficacy according to prior docetaxel therapy.

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	weekly nab-Paclitaxel therapy
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 NSCLC 2)Stage IIIb or IV 3)no EGFR mutation (exon19 deletion or L858R in exon 21) nor ALK fusion gene 4)two or three previous chemotherapy 5)age>20 6)ECOG PS 0-2 7)adequate organ function 8)expected survival days>90 9)written informed consesnt
Key exclusion criteria	1)symptomatic brain metastasis 2)massive or uncontrolable pleural effusion 3)less than two weeks after palliative irradiation for bone metastases or the brain metastasis except the primary tumor 4)previous chemotherapy with paclitaxel or nab-paclitaxel 5)active concomitant malignancy 6)active infectious disease 7)severe comorbidity 8)history of severe drug allergy 9)continuous steroid therapy 10)phsychiatry disease 11)pregnant or lactating woman 12)HBs antigen positive 13)Peripheral neuropathy>CTCAE Grade2 14)interstitial pneumoia or active lung fibrosis on chest X-ray 15)Otherwise determined by the investigator to be unsuitable as a subject in this study
Target sample size	38

Research contact person
Name of lead principal investigator	Hiroshige Yoshioka
Organization	Kurashiki Central Hospital
Division name	Department of Respiratory Medicine
Address	Miwa1-1-1, Kurashiki, Okayama, Japan
TEL	086-422-0210
Email	hirotin@kchnet.or.jp

Public contact
Name of contact person	Takashi Niwa
Organization	Kurashiki Central Hospital
Division name	Department of Respiratory Medicine
Address	Miwa1-1-1, Kurashiki, Okayama, Japan
TEL	086-422-0210
Homepage URL
Email	tn13545@kchnet.or.jp

Sponsor
Institute	Kurashiki Central Hospital
Institute
Department

Funding Source
Organization	Kurashiki Central Hospital
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	神奈川県立循環器呼吸器病センター（神奈川県）、岸和田市民病院（大阪府）、九州がんセンター（福岡県）、倉敷中央病院（岡山県）、久留米大学病院（福岡県）、神戸市立医療センター中央市民病院（兵庫県）、神戸市立医療センター西市民病院（兵庫県）、静岡県立静岡がんセンター（静岡県）、順天堂大学医学部付属順天堂病院（東京都）、名古屋医療センター（愛知県）、和歌山県立医科大学付属病院（和歌山県）

Other administrative information
Date of disclosure of the study information	2015 Year 01 Month 15 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 11 Month 18 Day
Anticipated trial start date	2015 Year 02 Month 02 Day
Last follow-up date	2018 Year 12 Month 31 Day
Date of closure to data entry	2018 Year 12 Month 31 Day
Date trial data considered complete	2018 Year 12 Month 31 Day
Date analysis concluded	2019 Year 02 Month 26 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2015 Year 01 Month 09 Day
Last modified on	2019 Year 03 Month 04 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018268