UMIN-CTR Clinical Trial

Basic information
Public title	Prospective study for clarification of mechanisms of acquired resistance for afatinib using plasma samples
Acronym	Study for acquired resistance mechanisms for afatinib using plasma samples
Scientific Title	Prospective study for clarification of mechanisms of acquired resistance for afatinib using plasma samples
Scientific Title:Acronym	Study for acquired resistance mechanisms for afatinib using plasma samples
Region	Japan

Condition
Condition	Non-small cell lung cancer
Classification by specialty	Pneumology Chest surgery
Classification by malignancy	Malignancy
Genomic information	YES

Objectives
Narrative objectives1	The purpose of this prospective study is to determine the mechanisms of acquired resistance for afatinib as the first line treatment of non small cell lung cancer using plasma samples.
Basic objectives2	Others
Basic objectives -Others	The study is to determine relation of detected mutations from ctDNA before afatiib treatment by NGS and effect of afatinib. Furthermore the study is to determine relation of detected mutations from ctDNA at acquired resistance to afatinib by NGS and effect of osimertinib.
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	Examination of variety and rate of gene abnormality detected from plasma at the time of acquired resistance for afatinib.
Key secondary outcomes	Examination of variety and rate of gene abnormality detected from ctDNA before and at the time of acquired resistance for afatinib. Examination about correlation of gene abnormality detected from ctDNA and response rate, progression free survival and time to treatment.

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	1. StageIIIB or IV non-small cell lung cancer patients with EGFR activating mutations such as exon 19 deletion, L858R, L861Q and G719X. 2. Patient is treated with afatinib as the first line therapy. 3. Non-small cell lung cancer patients with lesions which can be evaluated by RECIST (Version 1.1). 4. Patients with non-small-cell lung cancer (NSCLC) confirmed histologically or cytologically. 5. Non-small cell lung cancer patients with written consent.
Key exclusion criteria	1. Previously treated with an EGFR TKI. 2. Previously treated with an immune checkpoint inhibitor. 3. Patients who, in the opinion of the attending physician, are inappropriate for the study .
Target sample size	40

Research contact person
Name of lead principal investigator	1st name Naoko Middle name Last name Aragane
Organization	Saga Univ, Faculty of Medicine
Division name	Division of Hematology, Respiratory Medicine and Oncology
Zip code	849-8501
Address	5-1-1 Nabeshima, Saga
TEL	0952-34-2369
Email	sueokan@cc.saga-u.ac.jp

Public contact
Name of contact person	1st name Tomomi Middle name Last name Nakamura
Organization	Saga Univ, Faculty of Medicine
Division name	Division of Hematology, Respiratory Medicine and Oncology
Zip code	849-8501
Address	5-1-1 Nabeshima, Saga
TEL	0952-34-2369
Homepage URL
Email	nakamurt@cc.saga-u.ac.jp

Sponsor
Institute	Saga Univ,Clinical research center
Institute
Department

Funding Source
Organization	None
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	Clinical research center of saga university hospital
Address	5-1-1 Nabeshima, Saga, Japan
Tel	0952-34-3400
Email	kenkyu-shinsei@ml.cc.saga-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	2017 Year 02 Month 13 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	29
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	2017 Year 01 Month 12 Day
Date of IRB	2017 Year 01 Month 12 Day
Anticipated trial start date	2017 Year 02 Month 20 Day
Last follow-up date	2021 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Variety and rate of gene abnormality detected from plasma at the time of acquired resistance for afatinib.

Management information
Registered date	2017 Year 02 Month 13 Day
Last modified on	2019 Year 08 Month 19 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000030004