UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The Phase II study on the efficacy and safety of weekly nab-paclitaxel with 3 rd line therapy or more of advanced or recurrent non-small cell lung cancer after disease progression on 2nd line therapy or more
Title of the study (Brief title)	The Phase II study on the efficacy and safety of weekly nab-paclitaxel with 3 rd line therapy or more of advanced or recurrent non-small cell lung cancer after disease progression on 2nd line therapy or more
Region	Japan

Condition
Condition	Advanced or recurrent non-small cell lung cancer
Classification by specialty	Pneumology
Classification by malignancy	Malignancy
Genomic information	YES

Objectives
Narrative objectives1	We consider the efficacy and safety of 3rd or 4th line weekly nab-paclitaxel therapy of advanced or recurrent non-small cell lung cancer with 2 regimen or more chemotherapeutic treatment history.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase	Phase II

Assessment
Primary outcomes	Disease Control Rate
Key secondary outcomes	Response Rate, Overall survival, Progression free survival, Time to Treatment Failure, Adverse events (adverse reactions) occurrence rate

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
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.Non-small cell lung cancer with cytological (except sputum cytology) or histologically diagnosis. 2.There is a chemotherapy treatment history of 2 or 3 regimen that includes a platinum doublet therapy and docetaxel single agent therapy. In addition, it does not count as one regimen for EGFR-TKI and ALK inhibitor. However, erlotinib for EGFR gene mutation with wild type to count as 1 regimen. In addition, for patients who relapsed within 6 months from adjuvant chemotherapy last administration day, it counted as one regimen the last dose regimen of adjuvant chemotherapy. 3.It has been passed after 2 weeks or more from radiation therapy. 4.Cases with measurable lesions. 5.Age cases of more than 20 year old 6.ECOG Performance status (PS) 0-2. 7.Major organ function (bone marrow, heart, liver, kidney, etc.) is satisfaction on registrationin date from 14 days. The number of neutrophils: >= 1,500 /mm3 Hemoglobin value: >= 8.5 g/dL Platelet count : >= 100,000/mm3 AST value, ALT values: <= 100 IU/L Total bilirubin: <= 1.5 mg/dL Serum creatinine values: <= 1.5mg/dL Cardiac function: No abnormal findings it becomes clinical problem Peripheral neuropathy: <= Grade1 Respiratory function: SpO2: 90% or more 8.Patients can be expected survival from three months or more after treatment started. 9.Patient has agreed for participation in this study in writing.
Key exclusion criteria	1.Patients with paclitaxel treatment history. 2.Patients with hypersensitivity to paclitaxel or preparations containing albumin. 3.Patients with active double cancer in need of treatment. However it is not excluded that carcinoma in situ that is judged to be healing by local treatment, intramucosal cancer equivalent of lesions or other cancers unlikely in need of treatment. 4.The infection requiring systemic treatment (including patient of HBs antigen-positive). 5.Serious complications (heart disease, interstitial pneumonia, uncontrolled high blood pressure or diabetes, etc.) 6.there is a possibility of pregnancy or during pregnancy or lactating women. 7.Patients with psychosis or psychotic symptoms is determined to be difficult to participants in a clinical trial. 8.Patients during systemic administration steroids therapy(oral or intravenous). 9.Patients with symptomatic brain metastases. 10.Other, cases physicians it is judged unsuitable for registration of this clinical trial.
Target sample size	36

Research contact person
Name of lead principal investigator	Nobuhiko Seki
Organization	Department of Internal Medicine Teikyo University School of Medicine
Division name	Division of Medical Oncology
Address	2-11-1 Kaga, Itabashi-ku, Tokyo, Japan
TEL	+81-3-3964-1211
Email	nseki@med.teikyo-u.ac.jp

Public contact
Name of contact person	Takeshi Honda
Organization	Department of Internal Medicine Teikyo University School of Medicine
Division name	Division of Medical Oncology
Address	2-11-1 Kaga, Itabashi-ku, Tokyo, Japan
TEL	+81-3-3964-1211
Homepage URL
Email	thonda@med.teikyo-u.ac.jp

Sponsor
Institute	Division of Medical Oncology Department of Internal Medicine Teikyo University School of Medicine
Institute
Department

Funding Source
Organization	Division of Medical Oncology Department of Internal Medicine Teikyo University School of 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	帝京大学医学部内科学講座 腫瘍内科

Other administrative information
Date of disclosure of the study information	2016 Year 08 Month 25 Day

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2014 Year 12 Month 01 Day
Anticipated trial start date	2014 Year 12 Month 01 Day
Last follow-up date	2017 Year 07 Month 31 Day
Date of closure to data entry	2019 Year 07 Month 31 Day
Date trial data considered complete	2019 Year 07 Month 31 Day
Date analysis concluded	2019 Year 07 Month 31 Day

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

Management information
Registered date	2016 Year 08 Month 25 Day
Last modified on	2016 Year 08 Month 25 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018461