UMIN-CTR Clinical Trial

Basic information
Public title	Phase II study of ramucirumab plus docetaxel plus pegfilgrastim with stage IV non-small cell lung cancer patients
Acronym	Phase II study of ramucirumab plus docetaxel plus pegfilgrastim with stage IV non-small cell lung cancer patients
Scientific Title	Phase II study of ramucirumab plus docetaxel plus pegfilgrastim with stage IV non-small cell lung cancer patients
Scientific Title:Acronym	Phase II study of ramucirumab plus docetaxel plus pegfilgrastim with stage IV non-small cell lung cancer patients
Region	Japan

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

Objectives
Narrative objectives1	To evaluate efficacy and safety of ramucirumab plus docetaxel plus pegfilgrastim in stage IV 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
Key secondary outcomes	Progression free survival Overall Response Rate Disease Control Rate Overall Survival Safety, Toxicity

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	Addition of primary prophylaxis with pegfilgrastim to ramcirumab plus docetaxel 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

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.Patients who have previously treated with chemotherapy and have unresectable clinical stage IV or post-operative recurrence 3.Progression was observed during or after chemotherapy 4. More than twenty years old at the time of the agreement acquisition 5.ECOG Performace Status (PS) 0-1 6.Meets the following criteria absolute neutrophil: >=1500/mm3 platelet count: >=100,000/mm3 hemoglobin: >=10.0 g/dL AST and ALT: <=2.5 X ULN total bilirubin: <=ULN PT-INR: <=1.5 APTT: <=1.5 X ULN protein urea: <=1+ 7.Written informed consent to participate in this study
Key exclusion criteria	1. Symptomatic brain metastases 2. History of bleeding 3. Patient with HIV or HBV or HCV infection 4. Patient with active infection 5. Fever over 38 6. Patient with serious disease condition (severe heart disease, interstitial pneumonia, uncontrollable hypertension, diabetes mellitus, etc) 6. Severe complication (congestive heart failure, arrhythmia, uncontrollable hyper tension, uncontrollable diabetes) 7.Interstitial pneumonia , fibroid lung confirmed by CT. 8.Patient with much ascetic fluid, pleural effusion, cardiac effusion. 9. Patient with active double cancer. (Exclude disease free interval over 5 years and carcinoma in situ) 10. History of severe drug allergy 11.Patient with gastrointestinal perforation within 1 year. 12. Receiving anticoagulant therapy. (Aspirin 325mg or less to allow) 13. Patient thought as of high risk of bleeding (Obvious tumor invasion to main thoracic vessel and cavity) and of thromboembolizm. 14. History of docetaxel or ramcirumab treatment. 15. Considered as unfit to study drug administration by attending doctor according to clinical symptoms or laboratory abnormalities. 16. Considered to be interfere to the agreement or understanding the protocol by attening doctor. 17. Patient with impaired mental status. 18. Pregnancy 19. Other ineligible status judged by attending doctor.
Target sample size	20

Research contact person
Name of lead principal investigator	1st name Norimitsu Middle name Last name Kasahara
Organization	Gunma University
Division name	Department of Allergy and Respiratory Medicine
Zip code	371-8511
Address	3-39-15, Showa-machi, Maebashi, Gunma
TEL	027-220-7111
Email	m14702016@gunma-u.ac.jp

Public contact
Name of contact person	1st name Norimitsu Middle name Last name Kasahara
Organization	Gunma University
Division name	Department of Allergy and Respiratory Medicine
Zip code	371-8511
Address	3-39-15, Showa-machi, Maebashi, Gunma
TEL	027-220-7111
Homepage URL
Email	m14702016@gunma-u.ac.jp

Sponsor
Institute	Gunma University
Institute
Department

Funding Source
Organization	none
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Gunma Institutional Review Board
Address	3-39-15, Showa-machi, Maebashi, Gunma
Tel	027-220-7111
Email	m14702016@gunma-u.ac.jp

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

Other administrative information
Date of disclosure of the study information	2017 Year 02 Month 10 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled	20
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2017 Year 01 Month 26 Day
Date of IRB	2017 Year 01 Month 26 Day
Anticipated trial start date	2017 Year 02 Month 01 Day
Last follow-up date	2019 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2017 Year 02 Month 02 Day
Last modified on	2019 Year 08 Month 06 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000029855