UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Exploratory clinical study of first-line treatment for patients with advanced EGFR mutation-positive non-squamous non-small-cell lung cancer
Title of the study (Brief title)	Exploratory clinical study of first-line treatment for patients with advanced EGFR mutation-positive non-squamous non-small-cell lung cancer
Region	Japan

Condition
Condition	advanced EGFR mutation-positive non-squamous non-small cell lung cancer
Classification by specialty	Pneumology Hematology and clinical oncology Adult
Classification by malignancy	Malignancy
Genomic information	YES

Objectives
Narrative objectives1	Prior to the initiation of treatment for advanced or postoperative recurrence EGFR mutation-positive non-squamous non-small cell lung cancer, we ask questions on the treatment to the patients. We select the treatment that the patient desires, to assess the efficacy and safety.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	Progression free survival
Key secondary outcomes	Overall survival, Response rate, Adverse events, QOL

Base
Study type	Interventional

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

Intervention
No. of arms	3
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	EGFR-TKI monotherapy (gefitinib, erlotinib or afatinib)
Interventions/Control_2	maintenance therpy of gefitinib plus pemetrexed after gefitinib, carboplatin plus pemetrexed concurrent therapy
Interventions/Control_3	erlotinib plus bevacizumab therapy involving the insertion of the bevacizumab, cisplatin plus pemetrexed combination therapy
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.Cytologically or histologically documented non-squamous non-small cell lung cancer 2.EGFR activating mutation positive 3.Stage III without any indications for radiotherapy, Stage IV, or postoperative recurrence 4.chemotherapy naive 5.Prior palliative radiotherapy 1)Except to the primary pulmonary lesion 2)more than two weeks after palliative radiotherapy for bone metastasis 6.Evaluable lesions (Measuarable lesions are not necessary) 7.20 years of age or older at the time of consent 8.ECOG PS 0-1 9.Have adequate organ function within two weeks before study entry 10.Have signed an informed consent 11.Estimated life expectancy of at least 3 months
Key exclusion criteria	1.EGFR mutation Exon20 T790M positive 2.Symptomatic brain metastasis and a spinal metastases requiring surgical treatment or irradiation 3.Less than 5 years of disease-free interval with other malignancy 4.Pleural effusion, ascites or pericardial fluid in need of treatment 5.SVC syndrome 6.Spinal cord compression with symptoms 7.Cerebrovascular disorder with aymptoms 8.Unhealed fracture 9.Severe infection 10.Planned surgery during the study period 11.Obvious interstitial lung disease 12.Severe gastrointestinal disorder 13.Symptomatic corneal disease 14.Severe cardiac disease 15.Clinically significant drug allergy 16.Prior EGFR-TKI therapy 17.During pregnabcy or lactating woman 18.Uncontrolled psychiatric disease 19.Other
Target sample size	40

Research contact person
Name of lead principal investigator	Fumio Imamura
Organization	Osaka Medical Center for Cardiovascular diseases
Division name	Department of Thoracic Oncology
Address	1-3-3 Nakamichi Higashinari-ku, Osaka
TEL	06-6972-1181
Email	imamura-fu@mc.pref.osaka.jp

Public contact
Name of contact person	Kazumi Nishino
Organization	Osaka Medical Center for Cardiovascular diseases
Division name	Department of Thoracic Oncology
Address	1-3-3 Nakamichi Higashinari-ku, Osaka
TEL	06-6972-1181
Homepage URL
Email	nisino-ka@mc.pref.osaka.jp

Sponsor
Institute	Department of Thoracic Oncology Osaka Medical Center for Cardiovascular diseases
Institute
Department

Funding Source
Organization	no
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	大阪府立成人病センター(大阪府）

Other administrative information
Date of disclosure of the study information	2014 Year 10 Month 11 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2014 Year 10 Month 08 Day
Anticipated trial start date	2014 Year 10 Month 20 Day
Last follow-up date	2016 Year 10 Month 19 Day
Date of closure to data entry	2018 Year 10 Month 19 Day
Date trial data considered complete	2018 Year 10 Month 19 Day
Date analysis concluded	2018 Year 10 Month 19 Day

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

Management information
Registered date	2014 Year 10 Month 11 Day
Last modified on	2018 Year 04 Month 16 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000017924