UMIN-CTR Clinical Trial

Basic information
Public title	Monitoring EGFR mutation status with cell-free DNA: a prospective exploratory analyses of phase Ib study of osimertinib plus ramucirumab in lung adenocarcinoma patients with EGFR T790M mutation
Acronym	Exploratory analyses of Phase Ib study of osimertinib with ramucirumab
Scientific Title	Monitoring EGFR mutation status with cell-free DNA: a prospective exploratory analyses of phase Ib study of osimertinib plus ramucirumab in lung adenocarcinoma patients with EGFR T790M mutation
Scientific Title:Acronym	Exploratory analyses of Phase Ib study of osimertinib with ramucirumab
Region	Japan

Condition
Condition	Lung Cancer
Classification by specialty	Hematology and clinical oncology
Classification by malignancy	Malignancy
Genomic information	YES

Objectives
Narrative objectives1	To assess the utility of liquid biopsy with Osimertinib plus ramucirumab
Basic objectives2	Others
Basic objectives -Others	Exploratory
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Change of EGFR T790M mutation during treatment
Key secondary outcomes

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	Osimertinib + ramucirumab
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) Those who participate in the phase Ib trial of osimertinib+ramucirumab, and can provide blood sample (mandatory) and tissue sample (optional). 2) Written informed consent was obtained.
Key exclusion criteria	None
Target sample size	6

Research contact person
Name of lead principal investigator	1st name Yasuhiro Middle name Last name Koh
Organization	Wakayama Medical University
Division name	Third Department of Internal Medicine
Zip code	641-8509
Address	Kimiidera 811-1, Wakayama-city, Wakayama, Japan
TEL	073-441-0619
Email	ykoh@wakayama-med.ac.jp

Public contact
Name of contact person	1st name Hiroaki Middle name Last name Akamatsu
Organization	Wakayama Medical University
Division name	Third Department of Internal Medicine
Zip code	641-8509
Address	Kimiidera 811-1, Wakayama-city, Wakayama, Japan
TEL	073-441-0619
Homepage URL
Email	h-akamat@wakayama-med.ac.jp

Sponsor
Institute	Wakayama Medical University
Institute
Department

Funding Source
Organization	Eli Lilly and Company
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	Wakayama Medical University
Address	811-1, kimiidera
Tel	+81734410619
Email	wa-rinri@wakayama-med.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 11 Month 29 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	3
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	Main results already published
Date of protocol fixation	2017 Year 09 Month 19 Day
Date of IRB	2017 Year 09 Month 19 Day
Anticipated trial start date	2017 Year 11 Month 29 Day
Last follow-up date	2021 Year 09 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2017 Year 11 Month 29 Day
Last modified on	2021 Year 06 Month 03 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000034450