![]() |
UMIN-CTR Clinical Trial |
|
![]() |
![]() |
![]() |
![]() |
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 |
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 |
|
Condition | ||
Condition | ALK positive lung cancer | |
Classification by specialty |
|
|
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 |
|
|||
Age-upper limit |
|
|||
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 |
|
||||||
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 |
|
||||||
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 | |
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 |
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 |
|
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 |
|
||||||
Date of IRB |
|
||||||
Anticipated trial start date |
|
||||||
Last follow-up date |
|
||||||
Date of closure to data entry | |||||||
Date trial data considered complete | |||||||
Date analysis concluded |
Other | |
Other related information | none |
Management information | |||||||
Registered date |
|
||||||
Last modified on |
|
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 |