UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A Phase I/II study of nab-Paclitaxel plus S-1 therapy in previously treated patients with refractory advanced non-small-cell lung cancer
Title of the study (Brief title)	A Phase I/II study of nab-PTX plus S-1 therapy in previously treated patients with refractory advanced NSCLC
Region	Japan

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

Objectives
Narrative objectives1	To assess the efficacy and safety and determine the recommended dose of nab-Paclitaxel plus S-1 therapy as a third- or fourth-line therapy in patients with previously treated advanced or recurrent non-small cell lung cancer
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Phase I:Recomended dose Phase II:Disease control rate
Key secondary outcomes	Response rate, Progression free survival, Overall survival, 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	nab-Paclitaxel plus S-1therapy as a third- or fourth-line therapy in patients with previously treated advanced or recurrent non-small cell lung cancer
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 documented non-small-cell lung cancer (2)Stage IIIB without any indications for operation and radiotherapy or Stage IV (3)Have measuarable lesion by using the RECIST ver1.1 (Response Evaluation Criteria In Solid Tumors) criteria. (4)The lesions included in the radiation site are not measurable. (5)recurrent or refractory disease after two or three previous treatment regimens (including one platinum regimen regimen at least) (6)one regimen as ALK inhibitor or EGFR-TKI monotherapy (7)Adjuvant chemotherapy, including platinum doublet (but not counted as a regimen for one year after the final treatment) shall be one regimen. UFT is not counted as one regimen. (8)It is acceptable even if patients received paclitaxel, S-1 or nab-PTX as a pre-treatment. But if they received S-1 as a pre-treatment, they have to take at least one treatment-free TS1. (9)Must be 20 or more years old at tne time of consent (10)Have Eastern Coopperative Oncology Group Perfoemance Status (ECOG PS) 0-2 (11)The case can eat. (12)Have adequate organ function within two weeks before study entry. (13)Estimate life expectancy of at least 3 months (14)Have signed an informed consent document
Key exclusion criteria	(1)Presencee of other active malignancy (2)SVC syndrome (3)Myocardial infarction, which was developed within six months (4)Liver chirrosis (5)With interstitial pneumonia or pulmonary fibrosis on a chest X-ray (6)Clinically significant drug allergy (7)With severe infection, gastrointestinal hemorrhage or cardiac diseases (8)With persistent diarrhea (9)With with intestinal paralysis or ileus (10)Diabetes with poor control (11)With pericardial effusion, pleural effusion and ascites in need of treatment of drainage (12)Patients received palliative radiotherapy for brain metastases and bone metastases, except for the primary lesion within 2weeks. (13)Symptomatic brain metastasis (14)Peripheral neuropathy of Grade2 or more (15)Positive serum HBs antigen (16)Uncontrolled psychiatric diseases (17)Pregnancy or lactating patients (18)with a history of hypersensitivity to nab-PTX, S-1, paclitaxel, or albumin (19)Others
Target sample size	45

Research contact person
Name of lead principal investigator	Fumio Imamura
Organization	Osaka Medical Center for Cancer and Cardiovascular Diseases
Division name	Depatment of Thoracic Oncology
Address	1-3-3 Nakamichi Higashinari-ku, Osaka 537-8511
TEL	06-6972-1181
Email	imamura-fu@mc.pref.osaka.jp

Public contact
Name of contact person	Kazumi Nishino
Organization	Osaka Medical Center for Cancer and Cardiovascular Diseases
Division name	Depatment of Thoracic Oncology
Address	1-3-3 Nakamichi Higashinari-ku, Osaka 537-8511
TEL	06-6972-1181
Homepage URL
Email	nisino-ka@mc.pref.oska.jp

Sponsor
Institute	Depatment of Thoracic Oncology Osaka Medical Center for Cancer and Cardiovascular Diseases
Institute
Department

Funding Source
Organization	Depatment of Thoracic Oncology Osaka Medical Center for Cancer and Cardiovascular Diseases
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 01 Month 31 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2013 Year 10 Month 01 Day
Anticipated trial start date	2014 Year 02 Month 01 Day
Last follow-up date	2018 Year 01 Month 31 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
Other related information

Management information
Registered date	2014 Year 01 Month 26 Day
Last modified on	2016 Year 07 Month 31 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000015158