UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Biomarker testing for Personalized Therapy in real world setting; First line treatment decision in the advanced non-squamous NSCLC
Title of the study (Brief title)	BRAVE-Study Biomarker testing for Personalized Therapy in real world setting; First line treatment decision in the advanced non-squamous NSCLC
Region	Japan

Condition
Condition	non-squamous Non-small-cell lung carcinoma
Classification by specialty	Pneumology Chest surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To find out if necessary and sufficient biomarker testing* is conducted before starting the 1st line therapy in the advanced/metastatic non-squamous NSCLC patients
Basic objectives2	Others
Basic objectives -Others	1.To investigate the biomarker testing status in real world setting 2.To investigate the pattern of biomarker tests (types of testing and order) 3.To investigate the time required from definitive diagnosis until the start of treatment 4.To investigate the first-line treatment selected
Trial characteristics_1	Others
Trial characteristics_2	Others
Developmental phase	Not applicable

Assessment
Primary outcomes	Proportion of patients who could select first-line treatment based on the results of biomarker testing
Key secondary outcomes

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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.Patients with histologically confirmed non-squamous NSCLC who initiated first-line therapy between August 1, 2017 and December 31, 2017 2.Participants with locally advanced or metastatic non-squamous NSCLC at the diagnosis who were not indicated for radical surgery or radiotherapy 3.Patients with ECOG PS of 0-1 at the time of diagnosis 4.Patients who provided consent to participate in this study (However, in case of death or lost to follow-up, instructions from the Institutional Review Board at each site should be followed)
Key exclusion criteria	1.Patients with postoperative recurrence 2.Patients enrolled in clinical trials of an unapproved drug as first-line therapy for advanced NSCLC 3.Patients otherwise considered unsuitable to participate in this study by investigators at study sites
Target sample size	200

Research contact person
Name of lead principal investigator	Mari Matsubara
Organization	AstraZeneca K.K.
Division name	Medical, Oncology, Therapeutic Area
Address	Marunouchi Trust Tower 1-8-3, Marunouchi, Chiyoda-ku,Tokyo, Japan
TEL	+81-3-6268-2650
Email	Mari.Matsubara@astrazeneca.com

Public contact
Name of contact person	Nobuyoshi Hatanaka
Organization	Linical Co.,Ltd.
Division name	Contract Medical Affairs Clinical Trial Division
Address	1-6-1 Miyahara, Yodogawa-ku,Osakashi, Osaka,Japan
TEL	+81-6-6150-2210
Homepage URL
Email	hatanaka-nobuyoshi@linical.co.jp

Sponsor
Institute	AstraZeneca K.K.
Institute
Department

Funding Source
Organization	AstraZeneca K.K.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor	Linical Co.,Ltd.
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	YES
Study ID_1	D5160R00029
Org. issuing International ID_1	AstraZeneca K.K.
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions	愛知県がんセンター中央病院（愛知県）、北海道大学病院（北海道）、関西医科大学附属枚方病院（大阪府）、地方独立行政法人大阪府立病院機構大阪国際がんセンター（大阪府）、独立行政法人国立病院機構刀根山病院（大阪府）、埼玉県立がんセンター（埼玉県）、北九州市立医療センター（福岡県）、新潟県立がんセンター新潟病院（新潟県）、社会福祉法人 恩賜財団 済生会熊本病院（熊本県）、神奈川県立病院機構　神奈川県立がんセンター（神奈川県）

Other administrative information
Date of disclosure of the study information	2017 Year 12 Month 28 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 10 Month 20 Day
Anticipated trial start date	2018 Year 01 Month 10 Day
Last follow-up date	2018 Year 05 Month 21 Day
Date of closure to data entry	2018 Year 06 Month 14 Day
Date trial data considered complete	2018 Year 08 Month 02 Day
Date analysis concluded	2019 Year 01 Month 16 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	Study Design Japanese, multicenter, retrospective, observational study

Management information
Registered date	2017 Year 12 Month 28 Day
Last modified on	2019 Year 02 Month 22 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034960