UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Untreated IIIB/IV period with the EGFR mutation in the gene, phase II study of Gefitinib and the pemetrexed / bevacizumab combination maintenance therapy after Gefitinib and the cisplatin / pemetrexed / bevacizumab combination induction therapy for non-squamous epithelium non-small cell lung cancer of the latter recurrence
Title of the study (Brief title)	Untreated IIIB/IV period with the EGFR mutation in the gene, phase II study
Region	Japan

Condition
Condition	non-squamous non-small cell lung cancer
Classification by specialty	Pneumology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	We examine Gefitinib and Gefitinib after the cisplatin / pemetrexed / bevacizumab combination induction therapy and efficacy and safety of the pemetrexed / bevacizumab combination maintenance therapy for non-squamous epithelium non-small cell lung cancer of the postoperative recurrence untreated IIIB/IV period with the EGFR mutation in the gene.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Phase II

Assessment
Primary outcomes	1-year progression free survival rate
Key secondary outcomes	RR response rate DCP disease Control proportion OS overall survival PFS progression free survival AEs Adverse Events

Base
Study type	Interventional

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

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Randomization phase II study of the maintenance therapy with chemotherapy non-enforcement IIIB/IV period, pemetrexed following induction therapy with pemetrexed / cisplatin for patients with postoperative recurrent non-squamous epithelium non-small cell lung cancer or carboplatin
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	Not applicable
Gender	Male and Female
Key inclusion criteria	1 Histologically or cytologically confirmed non-squamuous, non-small cell lung cancer and stage IV or recurrent non-small cell lung cancer 2 A stage IIIB the clinic that radical irradiation is impossible of or stage IV and postoperative recurrence symptom example. 3 With the EGFR active form mutation in the gene more than G719X, 19del, L858R, one one of L861Q. 4 The case that recurred after the above after last administration for half a year of chemotherapy non-enforcement or the postoperative adjuvant chemotherapy. We exclude the case given Gefitinib or pemetrexed as postoperative adjuvant chemotherapy. Also, we do not include the picibanil which we used in pleurodesis and the minocycline in chemotherapy. 5 The age of the agreement acquisition day is a case younger than 75 years 20 years old or older. 6 ECOG Performance Status 0-1 7 With one or more measurable lesions based on RECIST version 1.1 8 Adequate organ function 9 The case that the survival that is more three months or more than the treatment starting date can expect. 10 An orally-available case. 11 The case that an agreement by the free will of the patients is obtained in a document about participation of this study.
Key exclusion criteria	1) The case that a squamous cancer ingredient accounts for more than 50% in the case of mixed type with the squamous cancer. 2) A mixed case with small cell lung cancer. 3) We have EGFR resistance gene mutation (T790M). 4) With the symptom or metastases to brain case to need treatment such as a steroid or the antispasmodic. 5) The case with a history of the hemoptysis or the merger. 6) The case with a history, the merger of the following sputum bloody.d 7) A case that was given the radiotherapy for the chest. 8) It is a case of after the palliative irradiation for bone metastases or the metastases to brain except the primary tumor for less than two weeks. 9) The invasion of the primary tumor is found in in great vessels in trachea or lobar bronchus or the TNM classification T4 of the lung cancer handling agreement revision seventh edition partly. 10) A case with the superior vena caval syndrome. 11) A case with the interstitial pneumonia that is clear by chest CT or pulmonary fibrosis. 12) The case with a serious infection. 13) The case with serious complications. 14) The case with pleural effusion, ascitic fluid requiring treatment such as the drainage and the pericardial fluid. 15)A case with the multiple primary cancer of the activity. 16)A case with a history of serious drug allergy. 17)Uncontrollable hypertension < 160/100 18) A case with a history of less than one year before merger of cerebrovascular disorder with the symptom or registration. 19) Need to antiplatelet therapy or anticoagulation therapy without Aspirin 325 mg/day 20) Gastrointestinal perforation within 1 year 21) The case that it was judged mental disorder to become the clinical problem to have difficulty in registration to this study. 22) With pregnancy and the pregnant likelihood or women nursing or men in hope of fertility. 23)Inappropriate for this study judged by the attending physician
Target sample size	27

Research contact person
Name of lead principal investigator	Seisuke Nagase
Organization	International University of Health and Welfare
Division name	Respiratory Disease Center
Address	1-4-3 Mita, Minato-ku, Tokyo, Japan
TEL	03-3451-8121
Email	snagase@iuhw.ac.jp

Public contact
Name of contact person	Seisuke Nagase
Organization	International University of Health and Welfare
Division name	Respiratory Disease Center
Address	1-4-3 Mita, Minato-ku, Tokyo, Japan
TEL	03-3451-8121
Homepage URL
Email	snagase@iuhw.ac.jp

Sponsor
Institute	International University of Health and Welfare Respiratory Disease Center
Institute
Department

Funding Source
Organization	non
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	東京医科大学病院　呼吸器・甲状腺外科（東京都） 国際医療福祉大学三田病院　呼吸器センター（東京都）

Other administrative information
Date of disclosure of the study information	2015 Year 02 Month 16 Day

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2014 Year 12 Month 01 Day
Anticipated trial start date	2014 Year 12 Month 01 Day
Last follow-up date	2018 Year 05 Month 01 Day
Date of closure to data entry	2019 Year 05 Month 01 Day
Date trial data considered complete	2019 Year 05 Month 01 Day
Date analysis concluded	2019 Year 05 Month 01 Day

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

Management information
Registered date	2015 Year 02 Month 16 Day
Last modified on	2016 Year 08 Month 17 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019209