UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Erlotinib in non- or light-smoker patients with NSCLC harvoring wild type EGFR and wild type ALK
Title of the study (Brief title)	Erlotinib in light-smoking lung adenocarcinoma with wild EGFR and ALK
Region	Japan

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

Objectives
Narrative objectives1	Efficacy of erlitinib
Basic objectives2	Others
Basic objectives -Others	false negative rate of EGFR testing
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Response rate
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	Erlotinib
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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Lung adnocarcinoma Negative in the 1st EGFR and ALK test At least one cytotixic chemotherapy No EGFR-TKI treatment Eligible for erlotinib PS0-2 Sufficient organ function
Key exclusion criteria	Concomitant interstitial pneumonotis Concomitant other advanced cancer Smoing index > 100
Target sample size	55

Research contact person
Name of lead principal investigator	Fumio
Organization	Osaka Medical Center for Cancer and Cardiovascular Diseases
Division name	Department
Address	1-3-3 Nakamichi Higashinari-ku, Osaka 537-8511, Japan
TEL	0669721181
Email	imamura-fu@mc.pref.osaka.jp

Public contact
Name of contact person	F
Organization	Osaka
Division name	Department of Thoracic Oncology
Address	1-3-3 Nakamichi Higashinari-ku, Osaka 537-8511, Japan
TEL	0669721181
Homepage URL
Email	imamura-fu@mc.pref.osaka.jp

Sponsor
Institute	Department of Thoracic Oncology
Institute
Department

Funding Source
Organization	Department of Thoracic Oncology
Organization
Division
Category of Funding Organization	Self funding
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	2014 Year 02 Month 03 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2014 Year 01 Month 20 Day
Anticipated trial start date	2014 Year 02 Month 04 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	2014 Year 02 Month 03 Day
Last modified on	2016 Year 11 Month 28 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000015231