UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Phase II study of EGFR-TKI in elderly patients with lung cancer harboring EGFR gene mutation in liquid biopsy
Title of the study (Brief title)	Phase II study of EGFR-TKI in elderly patients with lung cancer harboring EGFR gene mutation in liquid biopsy (ALCSG-03)
Region	Japan

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

Objectives
Narrative objectives1	To evaluate the efficacy and safety of EGFR-TKI in elderly patients of lung cancer harboring EGFR gene mutation in liquid biopsy.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase	Phase II

Assessment
Primary outcomes	Response rate.
Key secondary outcomes	Safety, progression free survival, overall survival.

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Single agent Erlotinib or Gefitinib
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	70 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Eligibility includes; (1) Patients of lung cancer diagnosed with CT imaging by respiratory medicine specialist (2) Patients harboring EGFR gene mutation Exon19 deletion or L858R in liquid biopsy with Cobas ver2.0. (3) Clinical stage from IIIA toIV. (4) Patients aged 70 and over 70 years. (5) Patients who are not treated with EGFR-TKI previously. (6) Patients who can take EGFR-TKI orally. (7) Patients having adequate organ function. (8) Letter of consent
Key exclusion criteria	Patients are excluded if they have; (1) Severe concomitant disease. (2) Severe history of hypersensitivity. (3) Severe heart disease or arrhythmia. (4) Interstitial pneumonia. (5) Active infection. (6) Active peptic ulcer. (7) Active double cancer. (8) No measurable lesion.
Target sample size	26

Research contact person
Name of lead principal investigator	Yoshinobu Ohsaki
Organization	Asahikawa Medical University Hospital
Division name	Respiratory Center
Address	2-1-1-1 Midorigaoka-higashi, Asahikawa-shi, Hokkaido, 078-8510 Japan
TEL	0166-69-3290
Email	yohsaki@asahikawa-med.ac.jp

Public contact
Name of contact person	Ryohei Yoshida
Organization	Asahikawa Medical University Hospital
Division name	Respiratory Center
Address	2-1-1-1 Midorigaoka-higashi, Asahikawa-shi, Hokkaido, 078-8510 Japan
TEL	0166-69-3290
Homepage URL
Email	yryohei@asahiakwa-med.ac.jp

Sponsor
Institute	Respiratory Center. Asahikawa Medical University Hospital
Institute
Department

Funding Source
Organization	Respiratory Center. Asahikawa Medical University Hospital
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor	Asahikawa Lung Cancer Study Group(ALCSG)
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	2017 Year 02 Month 01 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2017 Year 01 Month 11 Day
Anticipated trial start date	2017 Year 02 Month 01 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	2017 Year 01 Month 11 Day
Last modified on	2017 Year 01 Month 11 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029483