UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Research for elucidating the resistance mechanism to RET tyrosine kinase inhibitors in patients with non-small-cell lung cancer harboring with RET fusion gene
Title of the study (Brief title)	Research for RET-TKI resistance in NSCLC harboring with RET fusion gene
Region	Japan

Condition
Condition	Advanced non-small-cell lung cancer harboring with RET fusion gene
Classification by specialty	Pneumology
Classification by malignancy	Malignancy
Genomic information	YES

Objectives
Narrative objectives1	To elucidate the resistance mechanism to RET-TKI alectinib in NSCLC harboring with RET fusion gene
Basic objectives2	Others
Basic objectives -Others	To elucidate the resistance mechanism to RET-TKI alectinib in NSCLC harboring with RET fusion gene using clinical sample before and after alectinib
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	To find out the resistance mechanism to RET-TKI alectinib in NSCLC harboring with RET fusion gene
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. Written informed consent 2. Histologically or cytologically diagnosed NSCLC 3. Unresectable locally advanced or metastatic disease 4. Tumor samples test positive for a RET fusion gene 5. Testing negative for an EGFR mutation 6. Testing negative for an ALK fusion gene
Key exclusion criteria	1. Having previously received alectinib 2.Patients whom an investigator deems ineligible for participation in this study for some other reason.
Target sample size	30

Research contact person
Name of lead principal investigator	Seiji Yano
Organization	Cancer Research Institute, Kanazawa University
Division name	Medical Oncology
Address	13-1 Takara-machi, Kanazawa, Ishikawa 920-0934
TEL	076-265-2794
Email	syano@staff.kanazawa-u.ac.jp

Public contact
Name of contact person	Tadaaki Yamada
Organization	Cancer Research Institute, Kanazawa University
Division name	Medical Oncology
Address	13-1 Takara-machi, Kanazawa, Ishikawa 920-0934
TEL	076-265-2794
Homepage URL
Email	tadaakiy@staff.kanazawa-u.ac.jp

Sponsor
Institute	Cancer Research Institute, Kanazawa University
Institute
Department

Funding Source
Organization	Japan Agency for Medical Research and Development (AMED)
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor	Hokkaido University National Cancer Center Hospital East The Cancer Institute Hospital of JFCR Tokyo University Nagoya University Hospital Hyogo Cancer Center Okayama University Hospital National Hospital Organization Kyushu Cancer Center
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	北海道大学大学院医学系研究科(北海道) 国立がん研究センター東病院(千葉県) がん研究会有明病院(東京都) 東京大学大学院医学系研究科(東京都) 名古屋大医学部附属病院(愛知県) 金沢大学附属病院(石川県) 兵庫県立がんセンター(兵庫県) 岡山大学病院(岡山県) 国立病院機構 九州がんセンター(福岡県)

Other administrative information
Date of disclosure of the study information	2016 Year 04 Month 12 Day

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2016 Year 02 Month 17 Day
Anticipated trial start date	2016 Year 05 Month 09 Day
Last follow-up date	2020 Year 12 Month 31 Day
Date of closure to data entry	2020 Year 12 Month 31 Day
Date trial data considered complete	2020 Year 12 Month 31 Day
Date analysis concluded	2020 Year 12 Month 31 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	To elucidate the resistance mechanism to RET-TKI alectinib using DNA, RNA, and proteins derived from clinical samples in patients with non-small-cell lung cancer harboring with RET fusion gene

Management information
Registered date	2016 Year 04 Month 06 Day
Last modified on	2016 Year 10 Month 11 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000025009