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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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 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

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

Value
https://center6.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