UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042617 |
|---|---|
| Receipt number | 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 20:08:37 |
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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
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
ygoto@ncc.go.jp
Sponsor or person
Institute
Japanese Society of Lung Cancer
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048196
