UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Feasibility study of pemetrexed / bevacizumab / erlotinib in chemotherapy naïve patients with non- small cell lung cancer harboring EGFR mutation
Title of the study (Brief title)	Feasibility Study of pemetrexed / bevacizumab / erlotinib
Region	Japan

Condition
Condition	Non-Small Cell Lung Cancer, Non-Squamous cell lung cancer
Classification by specialty	Pneumology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To determine recommended dose of Pemetrexed/Bevacizumab/Erlotinib in chemotherapy naïve patients with non- small cell lung cancer harboring EGFR mutation
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Phase I

Assessment
Primary outcomes	Feasibility of Pemetrexed/Bevacizumab/Erlotinib
Key secondary outcomes	Anti-tumor efficacy

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	If four or more of the 6-12 patients who had been originally allocated to the level 0 experienced DLT, additional 6-12 patients were enrolled to the level -1. If four or more patients experienced DLT at this level, we conclude there was no feasibility of this combination.
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	80 years-old >
Gender	Male and Female
Key inclusion criteria	1)Histology/cytology-proven non-squamous non-small cell lung cancer 2)Stage IIIB, IV and unsuitable for radiotherapy and postoperative recurrence 3)EGFR mutant patients(exclude T790M mutation) 4)With one or more measurable disease based on RECIST 5)Performance status(ECOG): 0-1 6)Age 20<80 7)Adequate organ function 8)Written informed consent
Key exclusion criteria	1) Interstitial pneumonia/lung fibrosis on chest X-ray 2) History of chest radiation therapy 3) History or complication of hemoptysis with 2.5ml per time or more and Continuous bloody phlegm more than 1 week or complication of bloody phlegm treated with continuous oral hemostatic agent. History or complication of bloody phlegm treated with infusional hemostatic agent. 4) Evidence of tumor invading a perihilar blood vessel, heart and major blood vessel on imaging 5) Evidence of tumor invading segmental bronchus 6) Symptomatic brain metastasis 7) Active hepatic disease 8) Having serious complications 9) Uncontrolled ascites, pleural effusion or cardiac effusion 10) History of multiple malignancies within 3 years 11) Planning of surgery during the trial 12) A pregnant woman, a nursing girl and woman with the possibility (intention) of the pregnancy, and 13) Having serious mental disorder 14) Previous drug allergy 15) Those judged to be not suitable by the attending physician
Target sample size	12

Research contact person
Name of lead principal investigator	Masao Ichiki
Organization	National Hospital Organization Kyushu Medical Center
Division name	Department of Respiratory Medicine
Address	1-8-1 Jigyohama Chuo-ku, Fukuoka 810-8563, Japan
TEL	092-852-0700
Email	ichiki@kyumed.jp

Public contact
Name of contact person	Masao Ichiki
Organization	National Hospital Organization Kyushu Medical Center
Division name	Department of Respiratory Medicine
Address	1-8-1 Jigyohama Chuo-ku, Fukuoka 810-8563, Japan
TEL	092-852-0700
Homepage URL
Email	ichiki@kyumed.jp

Sponsor
Institute	National Hospital Organization Kyushu Medical Center,Department of Respiratory Medicine
Institute
Department

Funding Source
Organization	National Hospital Organization Kyushu Medical Center Department of Respiratory Medicine
Organization
Division
Category of Funding Organization	Other
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	国立病院機構　九州医療センター呼吸器内科（福岡県）

Other administrative information
Date of disclosure of the study information	2014 Year 07 Month 04 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2014 Year 04 Month 24 Day
Anticipated trial start date	2014 Year 07 Month 03 Day
Last follow-up date	2018 Year 12 Month 31 Day
Date of closure to data entry	2018 Year 12 Month 31 Day
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 07 Month 04 Day
Last modified on	2017 Year 07 Month 06 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000016841