UMIN-CTR Clinical Trial

Basic information
Public title	A phase II, biomarker study using digital PCR method in EGFR mutated, advanced lung adenocarcinoma patients treated with afatinib. WJOG8114LTR
Acronym	Liquid biopsy study of afatinib.
Scientific Title	A phase II, biomarker study using digital PCR method in EGFR mutated, advanced lung adenocarcinoma patients treated with afatinib. WJOG8114LTR
Scientific Title:Acronym	Liquid biopsy study of afatinib.
Region	Japan

Condition
Condition	EGFR mutated, advanced lung adenocarcinoma
Classification by specialty	Hematology and clinical oncology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To investigate the concordance rate of EGFR mutation status between tumor tissue and serum. To evaluate the correlation between the quantitativity of sensitive EGFR mutation in serum / de novo T790M in tumor tissue and radiological efficacy assessment.
Basic objectives2	Others
Basic objectives -Others	Concordance rate of EGFR mutation status between tumor tissue and serum before afatinib treatment.
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Phase II

Assessment
Primary outcomes	Concordance rate of EGFR mutation status between tumor tissue and serum.
Key secondary outcomes	Clinical outcome; overall response rate, progression-free survival, and safety Biomarker analyses; EGFR mutation analysis using digital PCR method; 1. Tumor tissue and serum (before and after afatinib treatment), and 2. quantitative monitoring in serum Comprehensive analyses using next generation sequencing; tumor tissue and serum (before and after afatinib treatment) EGFR mutation (exon 19 deletion) analysis using blocking oligo dependent PCR method; tumor tissue and serum (before and after afatinib treatment)

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	Diagnosis
Type of intervention	Medicine
Interventions/Control_1	Afatinib 40mg/day
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) Pathologically confirmed lung adenocarcinoma 2) EGFR-TKI na&iuml;ve, recurrence / advanced case 3) Activating EGFR mutation is confirmed by tumor tissue 4) The remaining tumor tissue is available for this study. 5) Age >= 20 years 6) ECOG performance 0-1 7) With measurable target lesion as per RECIST 1.1 8) With adequate organ function 9) Expecte survival time is more than 90 days. 10) Provided written informed consent
Key exclusion criteria	1) Incapable of oral intake 2) With intestinal paralysis, or ileus 3) Chronic diarrhea 4)Exhibiting significant interstitial pneumonitis, or pulmonary fibrosis in the chest CT 5) Uncontrolled pleural / pericardial effusion, and ascites. 6) Symptomatic brain metastasis, or meningitis carcinomatosa. 7) Prior history of thoracic radiotherapy within 4 weeks 8) Prior surgery within 4 weeks 9) Active infection 10) Positive for HBs antigen 11) With severe complication 12) Concomitant cancers within 5 years 13) History of serious drug allergies 14) Patients requiring systemic steroid medication 15) With clinically problematic, psycho-neurologic diseases 16) Pregnancy, breast feeding, or hesitation in contraception 17) Other conditions not suitable for this study
Target sample size	55

Research contact person
Name of lead principal investigator	1st name Middle name Last name Nobuyuki Yamamoto
Organization	Wakayama medical university
Division name	Third department of internal medicine
Zip code
Address	811-1, Kimiidera, Wakayama-city
TEL	073-441-0619
Email	nbyamamo@wakayama-med.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Shinichiro Nakamura
Organization	West Japan Oncology Group
Division name	datacenter
Zip code
Address	Namba Plaza Bldg.3F 1-5-7,Motomachi Naniwa-ku,Osaka 556-0016 JAPAN
TEL	06-6633-7400
Homepage URL
Email	datacenter@wjog.jp

Sponsor
Institute	West Japan Oncology Group
Institute
Department

Funding Source
Organization	Boehringer Ingelheim
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
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 12 Month 05 Day

Related information
URL releasing protocol
Publication of results	Published

Result
URL related to results and publications	https://www.ncbi.nlm.nih.gov/pubmed/31027689
Number of participants that the trial has enrolled	57
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	Completed
Date of protocol fixation	2014 Year 11 Month 22 Day
Date of IRB	2012 Year 12 Month 26 Day
Anticipated trial start date	2015 Year 02 Month 20 Day
Last follow-up date	2018 Year 06 Month 02 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 12 Month 04 Day
Last modified on	2019 Year 07 Month 17 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018406