UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000043994
Receipt number R000050243
Scientific Title Comparative efficacy and safety of lorlatinib and alectinib for ALK rearrangement positive advanced non-small cell lung cancer in Asian and non-Asian patients: systematic review and network meta-analysis.
Date of disclosure of the study information 2021/04/22
Last modified on 2021/06/26 10:43:28

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Basic information

Public title

Comparative efficacy and safety of lorlatinib and alectinib for ALK rearrangement positive advanced non-small cell lung cancer in Asian and non-Asian patients: systematic review and network meta-analysis.

Acronym

lorlatinib versus alectinib

Scientific Title

Comparative efficacy and safety of lorlatinib and alectinib for ALK rearrangement positive advanced non-small cell lung cancer in Asian and non-Asian patients: systematic review and network meta-analysis.

Scientific Title:Acronym

lorlatinib versus alectinib

Region

Japan


Condition

Condition

non-small cell lung cacner

Classification by specialty

Medicine in general Pneumology Hematology and clinical oncology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To compare the efficacy and safety of lorlatinib and alectinib for ALK rearrangement positive advanced non-small cell lung cancer in overall patients and in subgroup of Asian and non-Asian patients

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Progression free survival(PFS)
overall survival(OS)
Grade 3 or higher of adverse events (G3-AEs)
in overall participants and subgroup with Asian and non-Asian patients

Key secondary outcomes

Progression free survival(PFS)
overall survival(OS)
Grade 3 or higher of adverse events (G3-AEs)
in patients with or without central nervous system metastasis and in subgroup by PS


Objective response rate (ObR)
Incidence of Any grade of any adverse events
Incidence of Any grade and grade 3 or higher of serious adverse events, nausea, diarrhea, increased AST levels, increased ALT levels, and pneumonitis.


Base

Study type

Others,meta-analysis etc


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

18 years-old <=

Age-upper limit

75 years-old >

Gender

Male and Female

Key inclusion criteria

Phase 3 randomized trials of patients with ALK positive ALK naive advanced non-small cell lung cancer with PS of 0-2

Key exclusion criteria

Studies for children
Observational studies

Target sample size

1000


Research contact person

Name of lead principal investigator

1st name Koichi
Middle name
Last name Ando

Organization

Showa University school of medicine

Division name

Department of Medicine, Division of Respiratory Medicine and Allergology,

Zip code

142-8666

Address

1-5-8 Hatanodai, Shinagawa-ku, Tokyo, 142-8555, Japan

TEL

03-3784-8532

Email

koichi-a@med.showa-u.ac.jp


Public contact

Name of contact person

1st name Koichi
Middle name
Last name Ando

Organization

Showa University school of medicine

Division name

Department of Medicine, Division of Respiratory Medicine and Allergology,

Zip code

142-8666

Address

1-5-8 Hatanodai, Shinagawa-ku, Tokyo, 142-8555, Japan

TEL

03-3784-8532

Homepage URL


Email

koichi-a@med.showa-u.ac.jp


Sponsor or person

Institute

Showa University school of medicine

Institute

Department

Personal name



Funding Source

Organization

Showa University school of medicine

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Showa University School of Medicine

Address

1-5-8 Hatanodai, Shinagawa-ku, Tokyo, 142-8555, Japan

Tel

03-3784-8532

Email

koichi-a@med.showa-u.ac.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

2021 Year 04 Month 22 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

2194

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

Completed

Date of protocol fixation

2021 Year 04 Month 21 Day

Date of IRB

2021 Year 04 Month 21 Day

Anticipated trial start date

2021 Year 04 Month 21 Day

Last follow-up date

2021 Year 06 Month 26 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

We planned a network meta-analysis comparing six treatment arms including lorlatinib, brigatinib, alectinib, ceritinib, crizotinib, and chemotherapy. The primary efficacy and safety endpoints were progression-free survival (PFS) and the incidence of Grade 3 or higher adverse events (G3-AEs), respectively. Subgroup analysis by race and by the presence of central nervous system metastasis were also planned.


Management information

Registered date

2021 Year 04 Month 21 Day

Last modified on

2021 Year 06 Month 26 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050243


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name