UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Phase I/II trial of weekly nab-paclitaxel as second- or third-line treatment in patients with advanced non-small-cell lung cancer(OLCSG1303)
Title of the study (Brief title)	Phase I/II trial of weekly nab-paclitaxel as second- or third-line treatment in patients with advanced non-small-cell lung cancer (OLCSG1303)
Region	Japan

Condition
Condition	Non-small Cell Lung Cancer
Classification by specialty	Medicine in general Pneumology Hematology and clinical oncology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	In phase 1 part, the feasibility of a weekly nab-PTX treatment are evaluated and the recommended schedule are decided for advanced / recurrent non-small cell lung cancer (NSCLC) as second- or third-line treatment (who had a history of prior platinum-based chemotherapy). In phase 2 part , the efficacy and safety are evaluated with the recommended schedule in phase 1 part.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Phase I,II

Assessment
Primary outcomes	Objective Response Rate
Key secondary outcomes	safety and tolerability profile, 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-PTX 100mg/m2 administration on day1, 8, 15, 22 intravenously q 4 weeks
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	Histologicaly or cytologicaly confirmed advanced non-small cell lung cancer. Wild type EGFR gene mutation (Unknown EGFR gene mutation status is allowed for squamous cell carcinoma). ALK fusion gene is negative or unknown. One or two prior regimens containing a platinum-based chemotherapy. Eastern Cooperative Oncology Group performance status 0-2. Patient has measurable lesion(s) according to the RECIST ver.1.1 criteria Adequate organ functions
Key exclusion criteria	a case who has a history of paclitaxel or nab-paclitaxel treatment. a case with symptom(s) caused by brain metastasis or a case with meningeal dissemination. a case who has treated with thoracic radiotherapy within 4 weeks or radiotherapy for other site(s) within 2 weeks a case who has major concomitant disease as interstitial lung disease, severe cardiac disease(unstable angina pectoris, history of myocardial infarction, uncontrolled arrhythmia, severe diabetes mellitus, active infection, HBV/ HCV hepatitis or liver cirrhosis ) a case who met contraindications on a nab-PTX package leaflet.
Target sample size	55

Research contact person
Name of lead principal investigator	Naoyuki Nogami
Organization	National Hospital Organization Shikoku Cancer Center
Division name	Department of Thoracic Oncology
Address	160 kou minamiumemoto-cho matsuyama-shi ehime pref.
TEL	81899991111
Email	nnogami@shikoku-cc.go.jp

Public contact
Name of contact person	Daijiro Harada
Organization	National Hospital Organization Shikoku Cancer Center
Division name	Department of Thoracic Oncology
Address	160 kou minamiumemoto-cho matsuyama-shi ehime pref.
TEL	81899991111
Homepage URL
Email	daharada@shikoku-cc.go.jp

Sponsor
Institute	Okayama Lung Cancer Study Group (OLCSG)
Institute
Department

Funding Source
Organization	Okayama Lung Cancer Study Group (OLCSG)
Organization
Division
Category of Funding Organization	Other
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	国立病院機構 四国がんセンター(愛媛県)、岡山大学病院（岡山県）､岡山赤十字病院（岡山県）、岩国医療センター（山口県）、神戸赤十字病院（兵庫県）、川崎病院（岡山県）、山口宇部医療センター（山口県）、中国中央病院（広島県）、岡山ろうさい病院（岡山県）、住友別子病院（愛媛県）、倉敷中央病院（岡山県）岡山医療センター（岡山県）、福山市民病院（広島県）、愛媛県立中央病院（愛媛県）

Other administrative information
Date of disclosure of the study information	2013 Year 11 Month 27 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 11 Month 20 Day
Anticipated trial start date	2013 Year 11 Month 26 Day
Last follow-up date	2017 Year 07 Month 11 Day
Date of closure to data entry	2017 Year 07 Month 27 Day
Date trial data considered complete	2017 Year 07 Month 27 Day
Date analysis concluded	2017 Year 08 Month 29 Day

Related information
URL releasing protocol
Publication of results	Partially published
URL releasing results
Results
Other related information

Management information
Registered date	2013 Year 11 Month 26 Day
Last modified on	2017 Year 12 Month 02 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000014495