UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000049225 |
|---|---|
| Receipt number | R000055846 |
| Scientific Title | Rechallenge of afatinib for EGFR mutated non-small cell lung cancer previously treated with osimertinib |
| Date of disclosure of the study information | 2022/10/17 |
| Last modified on | 2022/11/02 12:20:15 |
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Basic information
Public title
Rechallenge of afatinib for EGFR mutated non-small cell lung cancer previously treated with osimertinib
Acronym
Afatinib followed by osimertinib in patients with EGFR mutated NSCLC (REAL study)
Scientific Title
Rechallenge of afatinib for EGFR mutated non-small cell lung cancer previously treated with osimertinib
Scientific Title:Acronym
Afatinib followed by osimertinib in patients with EGFR mutated NSCLC (REAL study)
Region
| Japan |
Condition
Condition
Non-small cell lung cancer
Classification by specialty
| Pneumology | Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate the efficacy and safety of afatinib after resistance of first-line osimertinib in patients with NSCLC harboring EGFR mutation.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Objective response rate (ORR)
Key secondary outcomes
Safety (incidence rate and severity of adverse events)
Progression-free survival (PFS)
Overall survival (OS)
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Afatinib 40mg orally once daily
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Histologically or cytologically diagnosed non-squamous non-small cell lung cancer harboring drug sensitive EGFR mutation (exon19 deletion, L858R)
2) ECOG PS 0 or 1
3) Confirming disease progression after first line osimertinib monotherapy
4) Received at least one regimen of anticancer chemotherapy (cytotoxic agents, immune checkpoint inhibitor, anti-angiogenic inhibitors) as a second-line therapy after osimertinib resistance
5) Undergoing next generation sequencing-based gene panel tests after osimertinib resistance
6) Having at least one target legion for RECIST ver.1.1
7) Adequate organ functions judged by laboratory tests within 14 days prior to registration
AST<=100 U/L
ALT<=100 U/L
creatinine<=2.0 mg/dL
SpO2>=92%
Key exclusion criteria
1) Having active multiple malignancies
2) Having active infectious disease (hepatitis B, hepatitis C, tuberculosis, HIV infection)
3) Pregnancy, breastfeeding or suspected of being pregnant
4) Undergoing concurrent anticancer therapy (chemotherapy, radiotherapy, immunotherapy, biological therapy, hormonal therapy)
5) Undergoing surgical treatment with organ removal within 28 days prior to registration
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Kanda |
| Middle name | |
| Last name | Shintaro |
Organization
Shinshu University School of Medicine
Division name
Department of Hematology and Oncology
Zip code
3908082
Address
3-1-1, Asahi, Matsumoto, Nagano, Japan
TEL
0263-37-2554
skanda@shinshu-u.ac.jp
Public contact
Name of contact person
| 1st name | Taisuke |
| Middle name | |
| Last name | Araki |
Organization
Shinshu University School of Medicine
Division name
First Department of Internal Medicine
Zip code
390-0804
Address
3-1-1, Asahi, Matsumoto, Nagano, Japan
TEL
0263-37-2631
Homepage URL
shirasusan0516@gmail.com
Sponsor or person
Institute
Shinshu University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Shinshu University School of Medicine
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Department of Hematology and Oncology, Shinshu University School of Medicine
Address
3-1-1, Asahi, Matsumoto, Nagano, Japan
Tel
0263-37-2554
skanda@shinshu-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
| 2022 | Year | 10 | Month | 17 | 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
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
Enrolling by invitation
Date of protocol fixation
| 2022 | Year | 10 | Month | 12 | Day |
Date of IRB
| 2022 | Year | 10 | Month | 07 | Day |
Anticipated trial start date
| 2022 | Year | 10 | Month | 18 | Day |
Last follow-up date
| 2027 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 10 | Month | 15 | Day |
Last modified on
| 2022 | Year | 11 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000055846
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