UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052047 |
|---|---|
| Receipt number | R000058897 |
| Scientific Title | Ramucirumab plus Erlotinib as first-line treatment for advanced or recurrent non-small cell lung cancer harboring EGFR exon 21 L858R mutation: A multicenter retrospective observational cohort study in Japan (REAL-SPEED) |
| Date of disclosure of the study information | 2023/09/01 |
| Last modified on | 2025/04/29 18:16:06 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Ramucirumab plus Erlotinib as first-line treatment for advanced or recurrent non-small cell lung cancer harboring EGFR exon 21 L858R mutation: A multicenter retrospective observational cohort study in Japan (REAL-SPEED)
Acronym
Ramucirumab plus Erlotinib as first-line treatment for advanced or recurrent non-small cell lung cancer harboring EGFR exon 21 L858R mutation: A multicenter retrospective observational cohort study in Japan (REAL-SPEED)
Scientific Title
Ramucirumab plus Erlotinib as first-line treatment for advanced or recurrent non-small cell lung cancer harboring EGFR exon 21 L858R mutation: A multicenter retrospective observational cohort study in Japan (REAL-SPEED)
Scientific Title:Acronym
Ramucirumab plus Erlotinib as first-line treatment for advanced or recurrent non-small cell lung cancer harboring EGFR exon 21 L858R mutation: A multicenter retrospective observational cohort study in Japan (REAL-SPEED)
Region
| Japan |
Condition
Condition
Advanced or recurrent non-small cell lung cancer harboring EGFR exon21 L858R mutation
Classification by specialty
| Pneumology | Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Efficacy
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Time to treatment failure (TTF)
Key secondary outcomes
Overall survival (OS
Progression-free survival (PFS)
Progression-free survival 2 (PFS2)
Time to discontinuation of any EGFR-TKI (TD-TKI)
Time to failure of strategy (TFS)
Objective response rate (ORR)
Disease control rate (DCR)
Safety
Base
Study type
Observational
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Non-small cell lung cancer has been diagnosed by either histological diagnosis (excised specimen), biopsies or cellular diagnosis.
EGFR ex21 L858R mutation positive based on tissue or plasm specimen
Patients with unresectable stage III, stage IV disease according to TNM classification, Version 8, or recurrence after radical treatment by surgery or chemoradiation
Performance status (PS): 0-2
Patients who received Ramucirumab + Erlotinib therapy between 1 Nov. 2020 to 31 Aug. 2023
Key exclusion criteria
Active double cancers*
*Double cancers are synchronous double cancers and metachronous double cancers with a disease-free interval of <3 years, and lesions in carcinoma in situ or mucosal equivalent that are considered cured by local treatment should not be included in active double cancers.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Nobuhiko |
| Middle name | |
| Last name | Seki |
Organization
Department of Internal Medicine, Teikyo University School of Medicine
Division name
Division of Medical Oncology
Zip code
173-8605
Address
2-11-1 Kaga Itabashi-ku, Tokyo
TEL
03-3964-1211
nseki@med.teikyo-u.ac.jp
Public contact
Name of contact person
| 1st name | Masashi |
| Middle name | |
| Last name | Ishihara |
Organization
Department of Internal Medicine, Teikyo University School of Medicine
Division name
Division of Medical Oncology
Zip code
173-8605
Address
2-11-1 Kaga Itabashi-ku, Tokyo
TEL
03-3964-1211
Homepage URL
m.ishihara@med.teikyo-u.ac.jp
Sponsor or person
Institute
Teikyo University
Institute
Department
Personal name
Funding Source
Organization
Eli Lilly Japan K.K.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Teikyo University Ethical Review Board for Medical and Health Research Involving Human Subjects
Address
2-11-1 Kaga Itabashi-ku, Tokyo
Tel
03-3964-7256
turb-office@teikyo-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
| 2023 | Year | 09 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
168
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
No longer recruiting
Date of protocol fixation
| 2023 | Year | 04 | Month | 19 | Day |
Date of IRB
| 2023 | Year | 07 | Month | 12 | Day |
Anticipated trial start date
| 2023 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Multicenter Retrospective Study
Management information
Registered date
| 2023 | Year | 08 | Month | 30 | Day |
Last modified on
| 2025 | Year | 04 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058897
