UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A biomarker analysis of Afatinib treatment in patients with relapse of EGFR-T790M mutation-positive advanced lung adenocarcinoma after 3rd generation EGFR-TKI treatment.
Title of the study (Brief title)	A biomarker analysis of Afatinib treatment in patients with relapse of EGFR-T790M mutation-positive advanced lung adenocarcinoma after 3rd generation EGFR-TKI treatment.
Region	Japan

Condition
Condition	EGFR-T790M positive non-small-cell lung cancer relapsed after 3rd generation EGFR-TKI
Classification by specialty	Pneumology
Classification by malignancy	Malignancy
Genomic information	YES

Objectives
Narrative objectives1	The aim of this study is to investigate the utility of cell-free DNA for evaluating the mechanisms of resistance to 3rd generation EGFR-TKI, and the efficacy of afatinib treatment after relapsed 3rd generation EGFR-TKI
Basic objectives2	Others
Basic objectives -Others	Detection of drug resistance mechanisms to 3rd generation EGFR-TKI in plasma cell-free DNA
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Detection of biomarker for afatinib treatment in patients with relapse of EGFR-T790M mutation-positive advanced lung adenocarcinoma after 3rd generation EGFR-TKI treatment
Key secondary outcomes	progression free survival, response rate, safety

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	Consecutively administer oral dose of afatinib at 40 mg/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)EGFR mutation-poasitive lung adenocarcinoma 2)T790M mutation was detected after EGFR-TKI treatment, and refractory to 3rd generation EGFR-TKI 3)Eastern Cooperative Oncology Group(ECOG) performance status of 0 to 2 4)with evaluable lesion based on RESIST 5)written informed consent
Key exclusion criteria	1) Active double cancer (simultaneous double cancer/multiple cancer, and metachronous double cancer/multiple cancer within 5 years of disease-free period. However, carcinoma in situ and a lesion equivalent to intramucosal carcinoma judged cured by local therapy are not included as active double cancer/multiple cancer). 2) Evidence of interstitial pneumonia or pulmonary fibrosis by chest CT scan. 3) Symptomatic brain metastasis (clinically stable brain metastasis is eligible) 4) HBs antigen-positive 5) Infection requiring systemic treatment 6) Patients who, in the opinion of the attending physician, are inappropriate for the study
Target sample size	30

Research contact person
Name of lead principal investigator	Hidenobu Ishii
Organization	Kurume University School of Medicine
Division name	Division of Respirology, Neurology, and Rheumatology, Department of Internal Medicine
Address	67 Asahi-machi, Kurume, Fukuoka 830-0011, Japan
TEL	0942-31-7560
Email	ishii_hidenobu@med.kurume-u.ac.jp

Public contact
Name of contact person	Hidenobu Ishii
Organization	Kurume University School of Medicine
Division name	Division of Respirology, Neurology, and Rheumatology, Department of Internal Medicine
Address	67 Asahi-machi, Kurume, Fukuoka 830-0011, Japan
TEL	0942-31-7560
Homepage URL
Email	ishii_hidenobu@med.kurume-u.ac.jp

Sponsor
Institute	Kurume University School of Medicine
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)

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	2016 Year 12 Month 03 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2016 Year 07 Month 09 Day
Anticipated trial start date	2016 Year 07 Month 20 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2016 Year 12 Month 02 Day
Last modified on	2016 Year 12 Month 02 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028891