UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027985 |
|---|---|
| Receipt number | 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 09:34:22 |
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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
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
ichiki@kyumed.jp
Sponsor or person
Institute
National Hospital Organization Kyushu Medical Center,Department of Respiratory Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032049
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
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