UMIN-CTR Clinical Trial

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
Institute	Showa University school of medicine
Institute
Department

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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050243