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
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
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
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
