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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000042617
Receipt No. R000048196
Scientific Title Evaluation of lorlatinib efficacy of patients with EML4-ALK
Date of disclosure of the study information 2020/12/02
Last modified on 2020/12/01

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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
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 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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