UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Phase II study of more than second-line Nab-PTX for advanced non-small cell lung cancer which is previously treated with chemotherapy
Title of the study (Brief title)	Phase II Study of more than 2nd line Nab-PTX for NSCLC
Region	Japan

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

Objectives
Narrative objectives1	The purpose of this study is to evaluate the efficacy and safety of Nab-PTX as more than 2nd-line therapy in patients with stage IIIB/IV non-small-cell lung cancer
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	response rate
Key secondary outcomes	disease control rate, toxicities, progression-free survival, overall survival

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 at the dose of 100mg/m2 (day 1, 8, 15) is administered every 4 weeks. Treatment can be continued unless PD or toxicity that is not tolerable is found.
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) Definitively diagnosed with non-small cell lung cancer by the specimens histologically or cytologically. 2) Clinical Stage IIIB which curative radiotherapy is not indicated, IV 3) Prior chemotherapy is 1 or 2 regimen. Regimen count is defined as follows a. Exclude EGFR-TKI and ALK inhibitor b. Exclude continuation maintenance, include switch maintenance c. Include adjuvant chemotherapy 4) Age of 20 to 79 years 5) Without active cancer other than NSCLC 6) At least one measurable lesion 7) With adequate organ function a. neutrophil count => 1,500/mm^3 b. platelet => 100,000/mm^3 c. hemoglobin => 9.0g/dL d. AST/ALT < 2.5 times less than ULN e. T.Bil <= 1.5mg/dL f. serum creatinine <= 1.5mg/dL g. ECG: without clinically problematic abnorbomalities h. Peripheral neuropathy <= Grade 1 8) Life expectancy of at least 3 months 9) ECOG performance status 0 or 1 10) With written informed consent
Key exclusion criteria	1) Symptomatic brain metastasis 2) Pregnant females, possibly pregnant females, females wishing to become pregnant and nursing mothers. Males that are currently attempting to produce a pregnancy 3) With active double cancer or multicentric cancer 4) The peripheral sense neuropathy is Grade2 or more by CTCAE at registration. 5) Treated with radiotherapy within the past four weeks. 6) With a history of the treatment with Paclitaxel. 7) With clinically important complications. 8) Interstitial pneumonia or pulmonary fibrosis becomes the clinical problem 9) With pleural effusion or pericardial effusion accumulates which need drainage 10) With the history of hypersensivity for paclitaxel or albumin 11) Main organs had a serious medical risk factor, and the physicians judged treatment not to be safe. 12) Physician concludes that the patient's participation in this trial is inappropriate
Target sample size	37

Research contact person
Name of lead principal investigator	Yoshio Tomizawa
Organization	Incorporated Administrative Agency National Hospital Organization Nishigunma National Hospital
Division name	Department of Respiratory Medicine
Address	2854, Shibukawa-shi, Gunma, Japan
TEL	0279-23-3030
Email	ytomizawa@netnngh.hosp.go.jp

Public contact
Name of contact person	Yoshio Tomizawa
Organization	Incorporated Administrative Agency National Hospital Organization Nishigunma National Hospital
Division name	Department of Respiratory Medicine
Address	2854, Shibukawa-shi, Gunma, Japan
TEL	0279-23-3030
Homepage URL
Email	ytomizawa@netnngh.hosp.go.jp

Sponsor
Institute	Incorporated Administrative Agency National Hospital Organization Nishigunma National Hospital
Institute
Department

Funding Source
Organization	None
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	2013 Year 09 Month 20 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2013 Year 09 Month 01 Day
Anticipated trial start date	2013 Year 09 Month 01 Day
Last follow-up date	2018 Year 08 Month 31 Day
Date of closure to data entry	2018 Year 08 Month 31 Day
Date trial data considered complete	2018 Year 08 Month 31 Day
Date analysis concluded	2018 Year 08 Month 31 Day

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

Management information
Registered date	2013 Year 09 Month 20 Day
Last modified on	2017 Year 03 Month 24 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000013821