UMIN-CTR Clinical Trial

Basic information
Public title	PhaseII safety and efficacy study of alectinib in poor performance status patients with ALK positive, advanced NSCLC
Acronym	LOGIK1401
Scientific Title	PhaseII safety and efficacy study of alectinib in poor performance status patients with ALK positive, advanced NSCLC
Scientific Title:Acronym	LOGIK1401
Region	Japan

Condition
Condition	Non-Small Cell Lung Cancer
Classification by specialty	Pneumology
Classification by malignancy	Malignancy
Genomic information	YES

Objectives
Narrative objectives1	PhaseII safety and efficacy study of alectinib in poor performance status patients with ALK positive, advanced NSCLC
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Objective Response Rate
Key secondary outcomes	PS improvement rate Safety 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	Alectinib, 300 mg orally administered twice daily
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 diagnosis of NSCLC that is locally advanced or metastatic 2) Positive for ALK fusion gene by "immunohistochemistry (IHC) and fluorescence in-situ hybridisation (FISH)" or "RT-PCR" 3) ALK-TKI naive other than crizotinib 4) At least 1 measurable tumor lesion as per RECIST v1.1 5) Female or male, 20 years of age or older 6) ECOG performance status 2 to 4 7) Adequate organ function 8) Signed and dated informed consent
Key exclusion criteria	1) known interstitial fibrosis or interstitial lung disease 2) Evidence of active malignancy 3) Brain metastasis with disordered consciousness 4) Uncontrolled Grade >/=3 SVC syndrome, pericardial effusion, pleural effusion, ascites 6) Active infectious disease 7) Concurrent radiotherapy including lung field
Target sample size	17

Research contact person
Name of lead principal investigator	1st name Middle name Last name Isamu Okamoto
Organization	Kyushu University Hospital
Division name	Research Institute for Disease of the Chest / Center for Clinical and Translational Research
Zip code
Address	3-1-1 Maidashi ,Higashi-ku,Fukuoka,
TEL	092-642-5378
Email	okamotoi@kokyu.med.kyushu-u.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Eiji Iwama
Organization	Graduate School of Medical Sciences, Kyushu University
Division name	Faculty of Medical Sciences, Department of Comprehensive Clinical Oncology
Zip code
Address	3-1-1 Maidashi,Higashi-ku,Fukuoka,
TEL	092-642-5378
Homepage URL
Email	iwama@kokyu.med.kyushu-u.ac.jp

Sponsor
Institute	Lung Oncology Group in Kyushu, Japan (LOGIK)
Institute
Department

Funding Source
Organization	Clinical Research Support Center Kyushu
Organization
Division
Category of Funding Organization	Non profit foundation
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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 09 Month 09 Day

Related information
URL releasing protocol
Publication of results	Partially published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 09 Month 02 Day
Date of IRB	2014 Year 09 Month 16 Day
Anticipated trial start date	2014 Year 09 Month 02 Day
Last follow-up date	2017 Year 09 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2014 Year 09 Month 09 Day
Last modified on	2021 Year 03 Month 15 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000017561