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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000027985
Receipt No. R000032049
Scientific Title Nivolumab maintenance as monotherapy after carboplatine plus nab-paclitaxel for first-line treatment of advanced Non-small-cell lung cancer: Feasibility study
Date of disclosure of the study information 2017/07/31
Last modified on 2017/08/01

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Basic information
Public title Nivolumab maintenance as monotherapy after carboplatine plus nab-paclitaxel for first-line treatment of advanced Non-small-cell lung cancer: Feasibility study
Acronym Feasibility Study of nivolumab maintenance therapy
Scientific Title Nivolumab maintenance as monotherapy after carboplatine plus nab-paclitaxel for first-line treatment of advanced Non-small-cell lung cancer: Feasibility study
Scientific Title:Acronym Feasibility Study of nivolumab maintenance therapy
Region
Japan

Condition
Condition Non-Small Cell Lung Cancer
Classification by specialty
Pneumology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To determine recommended dose and cycles of carboplatine plus nab-paclitaxel for nivolumab maintenance therapy in non-small-cell lung cancer
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Phase I

Assessment
Primary outcomes Feasibility of nivolumab maintenance therapy after carboplatine plus nab-paclitaxel
Key secondary outcomes Anti-tumor efficacy

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 Level 1:carboplatin AUC 6+nab-paclitaxel,4cycles
Level 0:carboplatin AUC 5+nab-paclitaxel,3cycles

If 3 or more of the first 6 patients who had been originally allocated to the level 1 experienced nivolumab-induced grade 3-4 toxicity, additinal 6 patients were enrolled to the level 0. If 2 or less of the first 6 patients in level 1 who had experienced nivolumab-induced grade 3-4 toxicity,additinal 6 patients were enrolled to the level 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
80 years-old >
Gender Male and Female
Key inclusion criteria 1)Histology/cytology-proven non-small cell lung cancer
2)No prior treatment
3)Stage IIIB, IV and unsuitable for radiotherapy
4)EGFR(-),ALK(-)
5)PD-L1 staining:1%-49%
6)With one or more measurable disease based on RECIST
7)Performance status(ECOG): 0-1
8)Age 20<80
9)Adequate organ function
10)Written informed consent
Key exclusion criteria 1) Interstitial pneumonia/lung fibrosis on chest X-ray
2) History of chest radiation therapy
3) Auto-immuno disease patients
4) Receiving steroid therapy
5) Symptomatic brain metastasis
6) Active hepatic disease
7) Having serious complications
8) Uncontrolled ascites, pleural effusion or cardiac effusion
9) History of multiple malignancies within 3 years
10) Planning of surgery during the trial
11) A pregnant woman, a nursing girl and woman with the possibility (intention) of the pregnancy, and
12) Having serious mental disorder
13) Previous drug allergy
14) Those judged to be not suitable by the attending physician
Target sample size 12

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masao Ichiki
Organization National Hospital Organization Kyushu Medical Center
Division name Department of Respiratory Medicine
Zip code
Address 1-8-1 Jigyohama Chuo-ku, Fukuoka 810-8563, Japan
TEL 092-852-0700
Email ichiki@kyumed.jp

Public contact
Name of contact person
1st name
Middle name
Last name Masao Ichiki
Organization National Hospital Organization Kyushu Medical Center
Division name Department of Respiratory Medicine
Zip code
Address 1-8-1 Jigyohama Chuo-ku, Fukuoka 810-8563, Japan
TEL 092-852-0700
Homepage URL
Email ichiki@kyumed.jp

Sponsor
Institute National Hospital Organization Kyushu Medical Center,Department of Respiratory Medicine
Institute
Department

Funding Source
Organization National Hospital Organization Kyushu Medical Center,Department of Respiratory Medicine
Organization
Division
Category of Funding Organization Other
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 07 Month 31 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 Open public recruiting
Date of protocol fixation
2017 Year 06 Month 28 Day
Date of IRB
Anticipated trial start date
2017 Year 08 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 06 Month 28 Day
Last modified on
2017 Year 08 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032049

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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