UMIN-CTR Clinical Trial

Basic information
Public title	Evaluation of lorlatinib efficacy of patients with EML4-ALK
Acronym	Evaluation of lorlatinib efficacy of patients with EML4-ALK
Scientific Title	Evaluation of lorlatinib efficacy of patients with EML4-ALK
Scientific Title:Acronym	Lorlatinib ctDNA
Region	Japan

Condition
Condition	ALK positive lung cancer
Classification by specialty	Pneumology
Classification by malignancy	Malignancy
Genomic information	YES

Objectives
Narrative objectives1	Evaluate whether the effects of lorlatinib (response rate/PFS/OS) depend on the variants of EML4-ALK translocation detected by ctDNA.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	Response rate (RECIST evaluated by the investigators)
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	Inclusion criteria 1. Patients aged 20 years or more in whom lorlatinib administration is scheduled under a diagnosis of non-small cell lung cancer with ALK gene translocation 2. Non-responders to alectinib therapy (or patients for whom it is discontinued due to the exacerbation of the primary disease or adverse events) 3. Patients who previously received treatment with cytotoxic anticancer drugs or untreated patients
Key exclusion criteria	1. Patients from whom written informed consent regarding study participation was not obtained
Target sample size	150

Research contact person
Name of lead principal investigator	1st name Tetsuya Middle name Last name Mitsudomi
Organization	Kindai University Faculty of Medicine
Division name	Department of Surgery, Division of Thoracic Surgery
Zip code	589-8511
Address	377-2 Ohno-Higashi, Osaka-Sayama, 589-8511, Japan
TEL	072-366-0221
Email	mitsudom@med.kindai.ac.jp

Public contact
Name of contact person	1st name Yasushi Middle name Last name Goto
Organization	National Cancer Center Hospital
Division name	Thoracic Oncology
Zip code	104-0045
Address	5-1-1 Tsukiji Chuoku
TEL	0335422511
Homepage URL
Email	ygoto@ncc.go.jp

Sponsor
Institute	Japanese Society of Lung Cancer
Institute
Department

Funding Source
Organization	Self Funfing
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	National Cancer Center
Address	5-1-1 Tsukiji Chuoku Tokyo
Tel	0335422511
Email	irst@ml.res.ncc.go.jp

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	2020 Year 12 Month 02 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
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Number of participants that the trial has enrolled
Results
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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	Enrolling by invitation
Date of protocol fixation	2019 Year 02 Month 14 Day
Date of IRB	2019 Year 02 Month 14 Day
Anticipated trial start date	2019 Year 02 Month 14 Day
Last follow-up date	2021 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	none

Management information
Registered date	2020 Year 12 Month 01 Day
Last modified on	2020 Year 12 Month 01 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048196

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name

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