UMIN-CTR Clinical Trial

Basic information
Public title	Comparative efficacy of brigatinib and alectinib in ALK-rearrangement advanced non-small cell lung cancer with central nervous system metastasis: a network meta-analysis of phase3 randomized trials
Acronym	brigatinib veusus alectinib in NSCLC
Scientific Title	Comparative efficacy of brigatinib and alectinib in ALK-rearrangement advanced non-small cell lung cancer with central nervous system metastasis: a network meta-analysis of phase3 randomized trials
Scientific Title:Acronym	brigatinib veusus alectinib in NSCLC
Region	Japan

Condition
Condition	non-small cell lung cancer
Classification by specialty	Pneumology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To compare the efficacy of brigatinib and alectinib in ALK-arrangement advanced non-small cell lung cancer with central nervous system metastasis.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Progression free survival(PFS)
Key secondary outcomes	Objective response rate(ORR)

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	Not applicable
Gender	Male and Female
Key inclusion criteria	phase3 studies of brigatinib or alectinib in patients with ALK positive advanced non-small cell lung cancer
Key exclusion criteria	Studies of patients with double cancer, immunecompromised patients, patients of poor performance status, and patients previously treated with ALT-TKIs
Target sample size	500

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	142-8555
Address	1-5-8 Hatanodai, Shinagawa-ku, Tokyo, 142-8555, Japan
TEL	03-3784-8000
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	142-8555
Address	1-5-8 Hatanodai, Shinagawa-ku, Tokyo, 142-8555, Japan
TEL	03-3784-8000
Homepage URL
Email	koichi-a@med.showa-u.ac.jp

Sponsor
Institute	Showa University School of Medicine, Department of Medicine, Division of Respiratory Medicine and Allergology,
Institute
Department

Funding Source
Organization	Showa University School of Medicine, Department of Medicine, Division of Respiratory Medicine and Allergology,
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	03-3784-8000
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	2019 Year 05 Month 28 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	785
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	2019 Year 04 Month 10 Day
Date of IRB	2019 Year 04 Month 17 Day
Anticipated trial start date	2019 Year 05 Month 12 Day
Last follow-up date	2019 Year 12 Month 16 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other

Other related information

Background: There are few reports comparing the efficacy and safety of ALK gene translocation positive (ALK positive) advanced non-small cell lung cancer (NSCLC) with central nervous system metastasis (CM) between brigatinib and alectinib. Objective: To compare the efficacy and safety for ALK positive NSCLC with CM between brigatinib group (group B) and alectinib group (group A). Methods: Network meta-analysis (indirect comparison) of phase 3 test was performed, and subset analysis for CM cases was performed. The primary efficacy endpoint was progression-free survival (PFS), and the primary safety endpoint was Grade 3-5 adverse events (G3-5 AAEs). Results Three trials (n = 785) were included in this analysis. There was no significant difference in PFS between groups B and A [HR (95% CI) = 0.601 (0.212 to 1.362)]. The surface under the cumulative ranking curve (SUCRA), which is an indicator of relative efficacy, showed a better tendency in group B than in group A [SUCRA = 95.3% (group B) vs 54.8% (group A)]. The frequency of G3-5AAEs did not differ significantly between the two groups. Conclusion: Brigatinib has a relatively good efficacy profile for ALK positive non-small cell lung cancer with central nervous system metastasis, although it is not significant, compared with alectinib, and it is considered to be well tolerated. Further clinical studies are needed to validate the efficacy and safety of brigatinib for ALK positive advanced non-small cell lung cancer with central nervous system metastasis.

Management information
Registered date	2019 Year 05 Month 27 Day
Last modified on	2020 Year 01 Month 13 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041992