UMIN-CTR Clinical Trial

Basic information
Public title	Multi center observational study of resistance mechanisms to alectinib in patients with ALK-rearranged, unresectable, locally advanced or metastatic non-small cell lung cancer
Acronym	ALCURE(ALeCtinib Ultimate REsistance mechanisms study)
Scientific Title	Multi center observational study of resistance mechanisms to alectinib in patients with ALK-rearranged, unresectable, locally advanced or metastatic non-small cell lung cancer
Scientific Title:Acronym	ALCURE(ALeCtinib Ultimate REsistance mechanisms study)
Region	Japan

Condition
Condition	Non-small cell lung cancer
Classification by specialty	Pneumology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To uncover the resistance mechanisms to alectinib, and to explore the relationship between the resistance mechanisms and efficacy of first-line alectinib or second-line therapy in patients with ALK-rearranged, unresectable, locally advanced or metastatic non-small cell lung cancer.
Basic objectives2	Others
Basic objectives -Others	Efficacy of first-line alectinib and second-line therapy
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	To explore the resistance mechanisms to alectinib and relationship between the resistance mechanisms and efficacy of first-line alectinib and second-line therapy
Key secondary outcomes	To establish the patient derived cancer cell line and analyze the resistance mechanisms besides secondary mutations in ALK, and to analyze the immune microenvironment in ALK rearranged cancer

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 20 years of age or older at the time of signed consent. (2)Patients with locally advanced or metastatic ALK-rearranged non-small cell lung cancer. (3)Patients who treated with or are scheduled to start alectinib as first-line, based on the alectinib package insert. (4)Patients who can submit a tissue sample collected before alectinib is administered. (5)Patients who signed informed consent form before enrolling the study.
Key exclusion criteria	(1)Patients who are judged by physician in charge of a case to be inappropriate to participate in study.
Target sample size	200

Research contact person
Name of lead principal investigator	1st name Ryohei Middle name Last name KATAYAMA
Organization	The Cancer Chemotherapy Center of Japanese Foundation for Cancer Research
Division name	Division of Experimental Chemotherapy
Zip code	135-8550
Address	3-8-31 Ariake, Koto-ku, Tokyo, 135-8550, Japan
TEL	03-3520-0111
Email	ryohei.katayama@jfcr.or.jp

Public contact
Name of contact person	1st name The ALCURE Study Middle name Last name Research Secretariat
Organization	EP-CRSU Co.,Ltd.
Division name	Clinical Research Headquarters
Zip code	162-0814
Address	Acropolis TOKYO, 6-29 Shinogawamachi, Shinjuku-ku, Tokyo,162-0814, JAPAN
TEL	03-5804-5045
Homepage URL
Email	prj-alcure@eps.co.jp

Sponsor
Institute	Japanese Foundation for Cancer Research / CHUGAI PHARMACEUTICAL CO., LTD.
Institute
Department

Funding Source
Organization	CHUGAI PHARMACEUTICAL CO., LTD.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Non-Profit Organization MINS Institutional Review Board
Address	1-15-14, Dogenzaka, Shibuya, Tokyo, Japan
Tel	03-6416-1868
Email	npo-mins@j-irb.com

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	2019 Year 12 Month 19 Day

Related information
URL releasing protocol
Publication of results	Unpublished

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	No longer recruiting
Date of protocol fixation	2019 Year 09 Month 12 Day
Date of IRB	2019 Year 12 Month 18 Day
Anticipated trial start date	2019 Year 12 Month 24 Day
Last follow-up date	2023 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	The study is a non-interventional, unblinded, non-randomized, single-arm, observational study to be conducted under clinical settings that will use healthcare information obtained as the result of providing care most appropriate to patients with no restrictions on the use and extent of tests, medications, and other medical acts performed for diagnostic or therapeutic reasons.

Management information
Registered date	2019 Year 12 Month 19 Day
Last modified on	2021 Year 12 Month 20 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044395