UMIN-CTR Clinical Trial

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
Email	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
Email	shirasusan0516@gmail.com

Sponsor
Institute	Shinshu University School of Medicine
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055846