UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Multicenter Phase II study of erlotinib therapy in recurrent or advanced non-small cell lung cancer patients with Epidermal Growth Factor Receptor (EGFR) mutation
Title of the study (Brief title)	Phase II Study of erlotinib in EGFR mutation Non-Small Cell Lung Cancer.
Region	Japan

Condition
Condition	Non small cell lung cancer with Epidermal Growth Factor Receptor mutation
Classification by specialty	Pneumology
Classification by malignancy	Malignancy
Genomic information	YES

Objectives
Narrative objectives1	To evaluate the efficacy and safety of erlotinib in advanced or recurrent NSCLC with EGFR mutation in Exon 19 and 21.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Phase II

Assessment
Primary outcomes	Response Rate
Key secondary outcomes	Disease Contorol Rate,Safety,Progression Free Survival,Overall Survival

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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 treatment
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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1) Histologically or cytologically proven stage IIIb or IV non-small cell lung cancer. 2) Patients who have previously treated one or two chemotherapy. 3) No previous treatment with EGFR-TKI 4) Patients having EGFR mutation (exon 19 deletion or L858R) 5)Possible cases with oral administration. 6) Patient who has at least one or more measurable lesion by RECIST. 7)Performance status (ECOG)0-2. 8) Patients who can be hospitalized for two weeks after beginning of the treatment or under management to apply to it. 9) Patients aged 20 years or older. 10) Sufficient function of main organ and bone marrow filled the following criteria before two weeks from enrollment: *Leukocyte counts, 3,000/mm3 or over -12,000/mm3 or less. *Neutrophil counts, 1,500/mm3 or over -5000/mm3 or less. *Platelets, 100,000/mm3 or over. *Hemoglobin, 9.0g/dL or over. *AST and ALT, x 2 of upper limit of normal (ULN) or less. *Serum bilirubin, 1.5mg/dl or less. *Serum creatinin, x 1.5 of ULN or less. *SpO2 90% or above(room air). 11) Patients who are considered to survive for more than 3 months. 12) Interval (1)Chemotherapy: more than 4weeks after the last chemotherapy (2)Radiation: more than 12weeks after the thoracic irradiation or more than 2weeks after the last irradiation to the other organs (3)Operation: more than 4weeks after the last operation(including pleurodesis) 13)Written informed consent.
Key exclusion criteria	1)Patients with active lung disease such as interstitial pneumonia, pneumoconiosis, active radiation pneumonitis,or drug-induced pneumonitis. 2)Patients with massive pleural or pericardial effusion ,or ascites. 3)Patients with active severe infections. 4)Cases with past history of administration of HER related agents. [ex) gefitinib, lapatinib, trsutuzumab, cetuximab] 5)Impossible cases with oral administration. 6)Patients with active opthalmological disease. 7) Patients with active concomitant malignancy. 8) Patients with symptomatic brain metastasis. 9)Patients with double cancer. 10)Patients with uncontrollabe diabetes mellitus. 11)Patients with uncontrollable complications. 12)Inappropriate patients for this study judged by the physicians.
Target sample size	26

Research contact person
Name of lead principal investigator	Yoichi Nakanishi
Organization	Kyushu University, Graduate School of Medical Sciences
Division name	Research Institute for Diseases of the Chest
Address	3-1-1 Maidashi, higashi-ku, Fukuoka, Japan , 812-8582
TEL	092-642-5378
Email	yoichi@kokyu.med.kyushu-u.ac.jp

Public contact
Name of contact person	Koichi Takayama
Organization	Kyushu University, Graduate School of Medical Sciences
Division name	Research Institute for Diseases of the Chest
Address	3-1-1 Maidashi, higashi-ku, Fukuoka, Japan , 812-8582
TEL	092-642-5378
Homepage URL
Email	koichi-t@kokyu.med.kyushu-u.ac.jp

Sponsor
Institute	Lung Oncology Group in Kyushu, Japan (LOGIK)
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization	Clinical Research Support Center Kyushu
Organization
Division
Category of Funding Organization	Non profit foundation
Nationality of Funding Organization	Japan

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

九州大学病院（福岡県） 浜の町病院（福岡県） 福岡大学（福岡県） 国立病院機構 福岡東医療センター（福岡県） 済生会福岡総合病院（福岡県） 国立病院機構 九州医療センター（福岡県） 公立学校共済組合 九州中央病院（福岡県） 国立病院機構　福岡病院　（福岡県） 飯塚病院（福岡県） 産業医科大学病院（福岡県） 国立病院機構　大牟田病院（福岡県） 九州厚生年金病院（福岡県） 福岡大学　筑紫病院（福岡県） 北九州市立医療センター（福岡県） 久留米大学（福岡県） 大分大学（大分県） 大分県立病院（大分県） アルメイダ病院（大分県） 国立病院機構 大分医療センター（大分県） 佐賀大学（佐賀県） 長崎大学（長崎県） 健康保険諫早総合病院（長崎県） 春回会 井上病院（長崎県） 熊本大学 熊本地域医療センター（熊本県） 国立病院機構 熊本再春荘病院（熊本県） 熊本赤十字病院（熊本県） 国立病院機構 熊本医療センター（熊本県） 宮崎大学（宮崎県） 鹿児島大学（鹿児島県） 国立病院機構 南九州病院（鹿児島県） 川内医師会立市民病院（鹿児島県） 鹿児島厚生連病院（鹿児島県） 浦添総合病院（沖縄県） 琉球大学（沖縄県） 沖縄県立南部医療センター・こども医療センター（沖縄県） 国立病院機構 沖縄病院（沖縄県） 松山赤十字病院（愛媛県）

Other administrative information
Date of disclosure of the study information	2010 Year 03 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2009 Year 02 Month 20 Day
Anticipated trial start date	2009 Year 05 Month 01 Day
Last follow-up date	2012 Year 01 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol	http://www.logik.jp/
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2010 Year 03 Month 01 Day
Last modified on	2016 Year 07 Month 26 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000003950