UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A phase II study of docetaxel plus ramcirumab with pegfilgrastim in treated patients with advanced non-small cell lung cancer
Title of the study (Brief title)	A phase II study of docetaxel plus ramcirumab with pegfilgrastim in treated patients with advanced non-small cell lung cancer
Region	Japan

Condition
Condition	non-small cell lung cancer
Classification by specialty	Pneumology Hematology and clinical oncology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate efficacy and safety of docetaxel plus ramcirumab with pegfilgrastim in treated patients with advanced non-small cell lung cancer
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Incidence of febrile neutropenia during all cycles of ramucirumab plus docetaxel therapy
Key secondary outcomes	Response rate Overall survival Progression free survival Adverse events

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	Add pegfilgrastim to docetaxel plus ramcirumab treatment as primary prophylaxis
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 and/or cytologically proven non-small cell lung cancer 2)Previously treated non-small cell lung cancer, with stage III of unsuitable for radiotherapy, stage IV and recurrent disease 3)Patients who have treated with at least one cytotoxic chemotherapy (In patients with driver mutations such as EGFR mutation or ALK rearrangement, tyrosine kinase inhibitor treatement is required before enrolling this study.) 4)Have measurable lesion 5)Must be 20 or more years old at the time of consent 6)Have Eastern Cooperative Oncology Group Performance Status (ECOG PS) 0-1 7)Have adequate organ function within two week before study entry 8)Estimated life expectancy of at least 12 weeks 9)Have signed an informed consent document
Key exclusion criteria	1)Interstitial pneumonia , fibroid lung confirmed by CT. 2)History of serious drug allergy 3)Patient with much ascetic fluid, pleural effusion, cardiac effusion. 4)Obvious tumor invasion to main thoracic vessel 5)Have lung cavity 6)Histoly of hemoptysis within two months 7)History of thoracic radiation therapy 8)Tumor invasion to central airway 9)Uncontrolled coagulation disorder or receiving anticoagulant drugs 10)Have inflammatory bowel disease 11)History of thrombosis 12)Have active wounds 13)Uncontrollable hypertension 14)Proteinuria 15)Patient with active infection 16)Symptomatic brain metastases 17)Patient with active double cancers 18)Have active severe heart diseases 19)Patient with impaired mental status 20)Pregnancy 21)Other ineligible status judged by attending doctor
Target sample size	28

Research contact person
Name of lead principal investigator	Tomoya Kawaguchi
Organization	Osaka City University
Division name	Department of Respiratory Medicine
Address	1-4-3, Asahimachi, Abeno-ku, Osaka, 545-8585, Japan
TEL	06-6645-3793
Email	kawaguchi.tomoya@med.osaka-cu.ac.jp

Public contact
Name of contact person	Kenji Sawa
Organization	Osaka City University
Division name	Department of Respiratory Medicine
Address	1-4-3, Asahimachi, Abeno-ku, Osaka, 545-8585, Japan
TEL	06-6645-3793
Homepage URL
Email	sawa.kenji@med.osaka-cu.ac.jp

Sponsor
Institute	Osaka City University Department of Respiratory Medicine
Institute
Department

Funding Source
Organization	Osaka City University Department of Respiratory Medicine
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	大阪市立大学医学部附属病院（大阪府） ベルランド総合病院

Other administrative information
Date of disclosure of the study information	2017 Year 05 Month 08 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2017 Year 04 Month 30 Day
Anticipated trial start date	2017 Year 05 Month 08 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	2017 Year 05 Month 02 Day
Last modified on	2018 Year 12 Month 27 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031172