UMIN-CTR Clinical Trial

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

non-small cell lung cancer

Classification by specialty

Pneumology

Classification by malignancy

Malignancy

Genomic information

NO

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

Primary outcomes

Progression free survival(PFS)

Key secondary outcomes

Objective response rate(ORR)

Study type

Others,meta-analysis etc

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

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

Institute

Department

Personal name

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

Co-sponsor

Name of secondary funder(s)

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

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2019

Year

05

Month

28

Day

URL releasing protocol

Publication of results

Unpublished

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

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 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.

Registered date

2019

Year

05

Month

27

Day

Last modified on

2020

Year

01

Month

13

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041992