UMIN-CTR Clinical Trial

Basic information
Public title	A multicenter, prospective observational study of pegfilgrastim for the management of febrile neutropenia during ramucirumab plus docetaxel for patients with advanced non-small cell lung cancer (CJLSG 1602)
Acronym	Observational study of pegfilgrastim for the management of febrile neutropenia during ramucirumab plus docetaxel
Scientific Title	A multicenter, prospective observational study of pegfilgrastim for the management of febrile neutropenia during ramucirumab plus docetaxel for patients with advanced non-small cell lung cancer (CJLSG 1602)
Scientific Title:Acronym	Observational study of pegfilgrastim for the management of febrile neutropenia during ramucirumab plus docetaxel
Region	Japan

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

Objectives
Narrative objectives1	To evaluate the efficacy and safety of pegfilgrastim during ramucirumab plus docetaxel therapy
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	1) Incidence of febrile neutropenia during the first cycle of chemotherapy 2) Incidence of G4 neutropenia during the first cycle of chemotherapy 3) Incidence of G4 neutropenia during the all cycles of chemotherapy 4) Response rate 5) Relative dose intensity 6) Adverse events

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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) Histology/cytology-proven non-small cell lung cancer 2) Previously treated non-small cell lung cancer with stage III, IV or recurrent disease 3) Patient previously treated with at least two regimens of chemotherapy *It does not count as one regimen; treatment with PD-1/PD-L1 checkpoint inhibitors, anti-CTLA-4, EGFR-TKIs in patients with EGFR-mutated patients, ALK-TKIs in patients with ALK-positive patients, ROS-1-TKIs in patients with ROS-1-positive patients. *Recurrence within 6 months or less from the day adjuvant chemotherapy finished is considered a previous treatment. 4) Age of 70 years or over 5) Patients who are considered to survive for more than 3 months 6) Written informed consent 7) ECOG performance status of 0-2 8) Adequate organ function.
Key exclusion criteria	1) Active infection 2) Patients had brain tumors and/or brain metastases (symptomatic or requiring treatment) 3) Evidence of tumor invading a perihilar blood vessel 4) Having a cavitating lung tumor 5) History of pulmonary hemorrhage or hemoptysis over 2.5 ml within 2 months 6) Evidence of tumor invading segmental bronchus 7) Severe gastrointestinal complications 8) Having a history or evidence of thrombosis 9) Severe hypertension 10) Having a history or evidence of ILD complication 11) Having an allergy of ramucirumab, docetaxel and pegfilgrastim 12) Having a severe mental disorder 13) Pregnant woman 14) Patients whose participation in the trial is judged to be inappropriate by the doctor
Target sample size	35

Research contact person
Last name of lead principal investigator	1st name Middle name Last name Kazuyoshi Imaizumi
Organization	Fujita Health University School of Medicine
Division name	Department of Respiratory Medicine
Zip code
Address	1-98 Dengakugakubo, Kutsukake-cho, Toyoake, Aichi 470-1192, Japan
TEL	0562-93-9241
Email	jeanluc@fujita-hu.ac.jp

Public contact
1st name of contact person	1st name Middle name Last name Teppei Yamaguchi
Organization	Aichi Cancer Center Hospital
Division name	Department of Thoracic Oncology
Zip code
Address	1-1, Kanokoden, Chikusa-ku, Nagoya, Aichi 464-8681, Japan
TEL	052-762-6111
Homepage URL
Email	yteppei@aichi-cc.jp

Sponsor
Institute	Central Japan Lung Study Group (CJLSG)
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
Address
Tel
Email

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 04 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
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	Completed
Date of protocol fixation	2017 Year 02 Month 27 Day
Date of IRB	2017 Year 02 Month 27 Day
Anticipated trial start date	2017 Year 03 Month 01 Day
Last follow-up date	2018 Year 11 Month 06 Day
Date of closure to data entry	2019 Year 03 Month 15 Day
Date trial data considered complete	2019 Year 03 Month 15 Day
Date analysis concluded	2019 Year 03 Month 15 Day

Other
Other related information	To evaluate the efficacy and safety of pegfilgrastim during ramucirumab plus docetaxel therapy

Management information
Registered date	2017 Year 04 Month 10 Day
Last modified on	2019 Year 03 Month 17 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030233