UMIN-CTR Clinical Trial

Basic information
Public title	Study of association between effect of afatinib for EGFR-mutated non-small cell lung cancer and circulating free DNA detected with high sensitive analyses for EGFR mutation.
Acronym	Analysis of ctDNA and afatinib
Scientific Title	Study of association between effect of afatinib for EGFR-mutated non-small cell lung cancer and circulating free DNA detected with high sensitive analyses for EGFR mutation.
Scientific Title:Acronym	Analysis of ctDNA and afatinib
Region	Japan

Condition
Condition	non-small cell lung cancer
Classification by specialty	Pneumology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	By a high sensitive analysis, we try to detect EGFR activating mutations and resistant mutations from plasma of NSCLC patients receiving afatinib after treatment with first-generation EGFR-TKI. We also evaluate relationship between effect of afatinib and EGFR mutation status.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	detection rate of circulating free DNA from plasma after treatment for 2 months
Key secondary outcomes	association between amount of circulating free DNA and effect of 2nd generation EGFR-TKI (PFS, 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 Gene
Interventions/Control_1	From May 2014 to March 2016
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 confirmed non-squamous, non-small cell lung cancer 2.Stage or recurrent disease 3.EGFR mutation (exon 19 deletion,L858R) detected by PNA-LNA PCR clamp method 4.Discontinuation of 1st generation EGFR-TKI due to PD or toxicity 5.Planned treatment with afatinib 6.ECOG performance status (PS) 0 to 2 7.Adequate organ functions 8.Written informed consent
Key exclusion criteria	1.Interstitial pneumonitis or pulmonary fibrosis apparent on chest X-ray 2.Concomitant malignancies
Target sample size	30

Research contact person
Name of lead principal investigator	1st name Middle name Last name Makoto Maemondo
Organization	Miyagi Cancer Center
Division name	Respiratory Medicine
Zip code
Address	17-1 Nodayama Shiote Medeshima Natorishi Miyagi 981-1293
TEL	022-384-3151
Email	maemond-ma693@miyagi-pho.jp

Public contact
Name of contact person	1st name Middle name Last name Makoto Maemondo
Organization	Miyagi Cancer Center
Division name	Respiratory Medicine
Zip code
Address	17-1 Nodayama Shiote Medeshima Natorishi Miyagi 981-1293
TEL	022-384-3151
Homepage URL
Email	maemond-ma693@miyagi-pho.jp

Sponsor
Institute	Makoto Maemondo
Institute
Department

Funding Source
Organization	None
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
Address
Tel
Email

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	2014 Year 05 Month 28 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	Main results already published
Date of protocol fixation	2014 Year 05 Month 02 Day
Date of IRB	2014 Year 05 Month 22 Day
Anticipated trial start date	2014 Year 05 Month 23 Day
Last follow-up date	2017 Year 03 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	2014 Year 05 Month 27 Day
Last modified on	2021 Year 08 Month 06 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016286