UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000063348 |
|---|---|
| Receipt number | R000072512 |
| Scientific Title | Comparative Efficacy and Safety of First-Line Targeted Therapies for Advanced Non-Small-Cell Lung Cancer Harboring EGFR Exon 20 Insertion Mutations: A Systematic Review and Network Meta-Analysis of Randomized Controlled Trials |
| Date of disclosure of the study information | 2026/10/20 |
| Last modified on | 2026/10/20 13:41:03 |
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Basic information
Public title
Comparative efficacy and safety of first-line treatments for advanced EGFR exon 20 insertion-mutated non-small-cell lung cancer: a systematic review and network meta-analysis of randomized controlled trials
Acronym
First-line EGFR exon 20 insertion NSCLC network meta-analysis
Scientific Title
Comparative Efficacy and Safety of First-Line Targeted Therapies for Advanced Non-Small-Cell Lung Cancer Harboring EGFR Exon 20 Insertion Mutations: A Systematic Review and Network Meta-Analysis of Randomized Controlled Trials
Scientific Title:Acronym
First-line EGFR exon 20 insertion NSCLC network meta-analysis
Region
| Japan |
Condition
Condition
Unresectable locally advanced or metastatic non-small-cell lung cancer harboring EGFR exon 20 insertion mutations
Classification by specialty
| Pneumology | Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To compare the efficacy and safety of first-line targeted monotherapy or targeted therapy plus platinum-pemetrexed chemotherapy versus platinum-pemetrexed chemotherapy in adults with previously untreated advanced NSCLC harboring EGFR exon 20 insertion mutations, through a systematic review and network meta-analysis of randomized controlled trials. The primary outcome is progression-free survival.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Progression-free survival (PFS), preferentially assessed by blinded independent central review according to RECIST 1.1. Extract the hazard ratio and 95% confidence interval at the most mature appropriate available data cutoff for each trial. If central review is unavailable, record the trial-designated PFS estimate and assessment method.
Key secondary outcomes
Overall survival, objective response rate, grade 3 or higher treatment-emergent adverse events, serious adverse events, and adverse events leading to treatment discontinuation at the most mature appropriate available reporting timepoint in each trial. Treatment-related grade 3 or higher adverse events and intracranial activity will be assessed where definitions are comparable. Health-related quality of life will be summarized descriptively if instruments are incompatible.
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
Parallel-group RCTs of any phase in adults aged >=18 years with untreated advanced EGFR exon 20 insertion-mutated NSCLC, comparing targeted monotherapy or targeted therapy plus platinum-pemetrexed with eligible first-line regimens. Mixed cohorts require extractable randomized subgroup data. Papers, abstracts, registry and sponsor results require verifiable randomized numeric comparisons. All eligible trials will be included; abstract/sponsor-only reports will be excluded in sensitivity analysis.
Key exclusion criteria
Trials exclusively in previously treated advanced disease; nonrandomized comparative studies, single-arm studies, observational studies, case series, reviews, and studies without extractable randomized comparative data for the eligible mutation population. Multiple reports of the same trial will be linked and never counted as separate trials.
Target sample size
Research contact person
Name of lead principal investigator
| 1st name | Hao |
| Middle name | |
| Last name | Chen |
Organization
Yokohama City University Graduate School of Medicine
Division name
Department of Pulmonology
Zip code
236-0004
Address
3-9 Fukuura, Kanazawa-ku, Yokohama, Kanagawa, Japan
TEL
+81-45-787-2800
chinsmd@gmail.com
Public contact
Name of contact person
| 1st name | Hao |
| Middle name | |
| Last name | Chen |
Organization
Yokohama City University Graduate School of Medicine
Division name
Department of Pulmonology
Zip code
236-0004
Address
3-9 Fukuura, Kanazawa-ku, Yokohama, Kanagawa, Japan
TEL
+81-45-787-2800
Homepage URL
chinsmd@gmail.com
Sponsor or person
Institute
Yokohama City University
Institute
Department
Personal name
Hao Chen
Funding Source
Organization
No funding
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
None
IRB Contact (For public release)
Organization
No IRB required (public literature review); research contact: YCU Pulmonology
Address
Research contact: 3-9 Fukuura, Kanazawa-ku, Yokohama, Kanagawa, Japan
Tel
+81-45-787-2800
chinsmd@gmail.com
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
横浜市立大学（神奈川県）
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 10 | Month | 20 | 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
400
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
Not applicable. This systematic review uses publicly available aggregate data and will not collect individual participant data.
IPD sharing Plan description
Search strategies, exclusion logs, extracted aggregate data, risk-of-bias assessments and R scripts are planned to be shared in an open repository at publication, subject to institutional and copyright requirements. No conflicts of interest. No funding support.
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2026 | Year | 08 | Month | 20 | Day |
Date of IRB
| 2026 | Year | 07 | Month | 05 | Day |
Anticipated trial start date
| 2026 | Year | 10 | Month | 20 | Day |
Last follow-up date
| 2026 | Year | 12 | Month | 20 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2026 | Year | 12 | Month | 20 | Day |
Other
Other related information
Public aggregate-data review; no recruitment/IPD; no IRB required, COI or funding. Search PubMed, Embase, CENTRAL, trial registries and ASCO/ESMO/WCLC from inception; update before synthesis. Drug/dose-specific nodes; platinum-pemetrexed reference. Fixed-effect log-HR NMA in R/netmeta with multiarm correlation; assess transitivity/connectivity. RoB 2 and CINeMA/GRADE. Sensitivity: full papers, phase III, BICR PFS, similar chemotherapy. Rankings exploratory.
Management information
Registered date
| 2026 | Year | 10 | Month | 20 | Day |
Last modified on
| 2026 | Year | 10 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072512
