UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030938 |
|---|---|
| Receipt number | R000035329 |
| Scientific Title | A phase II study of Nivolumab re-challenge therapy after VEGF inhibitor therapy in patients with advanced non-small cell lung cancer. Gunma-Ibaraki-Fukushima-Tochigi (GIFT) group study |
| Date of disclosure of the study information | 2018/01/24 |
| Last modified on | 2026/01/28 13:20:09 |
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Basic information
Public title
A phase II study of Nivolumab re-challenge therapy after VEGF inhibitor therapy in patients with advanced non-small cell lung cancer.
Gunma-Ibaraki-Fukushima-Tochigi (GIFT) group study
Acronym
Nivolumab re-challenge therapy after VEGF inhibitor therapy.
Scientific Title
A phase II study of Nivolumab re-challenge therapy after VEGF inhibitor therapy in patients with advanced non-small cell lung cancer.
Gunma-Ibaraki-Fukushima-Tochigi (GIFT) group study
Scientific Title:Acronym
Nivolumab re-challenge therapy after VEGF inhibitor therapy.
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
Response of Nivolumab re-challenge therapy after VEGF inhibitor therapy in patients with advanced non-small cell lung cancer.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
Overall response rate
Key secondary outcomes
Progression free survival
Over all survival
Adverse events
Examination of the immunity
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
Nivolumab re-challenge therapy
(3mg/kg, every 2 weeks)
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 or cytologically proven non-squamous non-small cell lung cancer
2)Stage IIIB,stageIV without any indications for radiotherapy
3)Those who were benefit from anti PD-1 antibody therapy such as CR, PR, SD.
4)ECOG performance status 0-1
5)With one or more measurable disease (RECIST ver.1.1)
6)Aged 20<=
7)Adequate organ function
8)Less than two weeks interval after last VEGF inhibitor therapy
9)Written informed concent
Key exclusion criteria
1)Symptomatic brain metastasis
2)Active infections diseases
3)Serious complications
4)Active concomitant cancers
5)Severe adverse events of Nivolumab
6)Pregnancy, breastfeeding or suspected of being pregnant
7)Those judged to be not suitable by the attending physician
Target sample size
25
Research contact person
Name of lead principal investigator
| 1st name | TAKASHI |
| Middle name | |
| Last name | Kasai |
Organization
Tochigi Cancer Center
Division name
Department of Medical Oncology,
Zip code
320-0834
Address
4-9-13 Yonan, Utsunomiya, Tochigi
TEL
+81-28-658-5151
takasai@tochigi-cc.jp
Public contact
Name of contact person
| 1st name | Takashi |
| Middle name | |
| Last name | Kasai |
Organization
Tochigi Cancer Center
Division name
Department of Medical Oncology,
Zip code
320-0834
Address
4-9-13 Yonan, Utsunomiya, Tochigi
TEL
+81-28-658-5151
Homepage URL
takasai@tochigi-cc.jp
Sponsor or person
Institute
GIFT group
Institute
Department
Personal name
Funding Source
Organization
Ono Pharmaceutical Co., Ltd.
Bristol-Myers Squibb K.K.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tochigi Cancer Center
Address
4-9-13 Utsunomiya,Tochigi Japan
Tel
+81-28-658-5151
takasai@tochigi-cc.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
| 2018 | Year | 01 | Month | 24 | Day |
Related information
URL releasing protocol
none
Publication of results
Unpublished
Result
URL related to results and publications
We are analyzed it now.
Number of participants that the trial has enrolled
24
Results
We have seen patients with response.
Results date posted
| 2025 | Year | 07 | Month | 31 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
We have seen patients with response.
Participant flow
entry finished
Adverse events
tolerable
Outcome measures
We have seen patients with response.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2017 | Year | 10 | Month | 19 | Day |
Date of IRB
| 2017 | Year | 12 | Month | 20 | Day |
Anticipated trial start date
| 2018 | Year | 01 | Month | 07 | Day |
Last follow-up date
| 2023 | Year | 12 | 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
| 2018 | Year | 01 | Month | 22 | Day |
Last modified on
| 2026 | Year | 01 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035329
