UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026294 |
|---|---|
| Receipt number | R000030109 |
| Scientific Title | Exploration of predictive biomarkers of nivolumab monotherapy in previously treated patients with advanced non-small cell lung cancer (NSCLC) and NSCLC patients with postoperative recurrence |
| Date of disclosure of the study information | 2017/04/01 |
| Last modified on | 2021/02/27 15:25:03 |
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Basic information
Public title
Exploration of predictive biomarkers of
nivolumab monotherapy in previously
treated patients with advanced
non-small cell lung cancer (NSCLC) and
NSCLC patients with postoperative
recurrence
Acronym
Biomarker study on nivolumab monotherapy in
previously treated patients with advanced
NSCLC (GIFT-04/FIGHT-003)
Scientific Title
Exploration of predictive biomarkers of
nivolumab monotherapy in previously
treated patients with advanced
non-small cell lung cancer (NSCLC) and
NSCLC patients with postoperative
recurrence
Scientific Title:Acronym
Biomarker study on nivolumab monotherapy in
previously treated patients with advanced
NSCLC (GIFT-04/FIGHT-003)
Region
| Japan |
Condition
Condition
Advanced NSCLC and NSCLC with
postoperative recurrence
Classification by specialty
| Pneumology | Hematology and clinical oncology | Chest surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To explore predictive biomarkers of
nivolumab monotherapy in previously
treated patients with NSCLC and
NSCLC patients with postoperative
recurrence
Basic objectives2
Others
Basic objectives -Others
To explore biomarkers for overall
survival, progression free survival,
objective response rate and disease
control rate, such as blood
biomarker, adverse events graded in
Common Terminology Criteria for
Adverse Events (CTCAE) version 4.0,
or imaging characteristics of
computed tomography (CT), etc.
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Potential predictive biomarkers of
nivolumab monotherapy in previously
treated patients with advanced NSCLC
and NSCLC patients with postoperative
recurrence.
Key secondary outcomes
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with Advanced NSCLC
and NSCLC with postoperative
recurrence who are treated with
nivolumab monotherapy for 12
weeks in the institutions
affiliated with Gumma-Ibaraki-
Fukushima-Tochigi (GIFT) study
group and/or Fukushima
Investigative Group for Healing
Thoracic Malignancy (FIGHT), and
other cooperation hospitals
between Apr.1, 2013 and Mar.31, 2017.
Key exclusion criteria
None
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | Hiroyuki |
| Middle name | |
| Last name | Suzuki |
Organization
Fukushima Medical University, School
of Medicine
Division name
Department of Chest Surgery
Zip code
9601295
Address
1 Hikariga-oka, Fukushima City
TEL
0245471111
hiromine@fmu.ac.jp
Public contact
Name of contact person
| 1st name | Hiroyuki |
| Middle name | |
| Last name | Minemura |
Organization
Fukushima Medical University, School of Medicine
Division name
Department of Pulmonary Medicine
Zip code
9601295
Address
1 Hikariga-oka, Fukushima City
TEL
0245471111
Homepage URL
hiromine@fmu.ac.jp
Sponsor or person
Institute
Department of Chest Surgery,
Fukushima Medical University
Institute
Department
Personal name
Funding Source
Organization
Department of Pulmonary Medicine,
Fukushima Medical University
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
Fukushima Medical Univrsity
Address
Hikarigaoka Fukushiama city, Fukushiam Prefercure
Tel
0245471111
hiromine@fmu.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
福島県立医科大学
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 04 | Month | 01 | Day |
Related information
URL releasing protocol
https://onlinelibrary.wiley.com/doi/full/10.1111/1759-7714.13695
Publication of results
Published
Result
URL related to results and publications
https://onlinelibrary.wiley.com/doi/full/10.1111/1759-7714.13695
Number of participants that the trial has enrolled
78
Results
NSCLC with interstitial septal thickening may respond poorly to nivolumab.
Results date posted
| 2021 | Year | 02 | Month | 27 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
We reviewed the medical records of patients with recurrent or advanced NSCLC who were treated with nivolumab and were followed up for at least three months at Gunma Prefectural Cancer institute, Ibaraki Central Hospital, Fukushima Medical University Hospital, Tochigi Cancer Center Hospital or Aizu Medical Center Hospital between April 2013 and March 2017. We identified a total of 115 pretreated advanced NSCLC patients who had been treated with nivolumab.
Participant flow
Of these patients, 78 had undergone chest CT imaging before initiation of nivolumab treatment.
Adverse events
None
Outcome measures
the relation between therapeutic response to nivolumab and the morphological characteristics on CT images
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2017 | Year | 01 | Month | 27 | Day |
Date of IRB
| 2017 | Year | 04 | Month | 05 | Day |
Anticipated trial start date
| 2017 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
| 2018 | Year | 01 | Month | 31 | Day |
Date analysis concluded
| 2018 | Year | 03 | Month | 31 | Day |
Other
Other related information
Dependent variables
1) Patient characteristics (age, gender,
smoking history, etc.)
2) Characteristics of NSCLC (TNM staging,
histology, etc.)
3) Line of prior therapy
4) Immune related adverse events(irAE)
5) Laboratory test prior to nivolumab
monotherapy (white blood cell and
differential count, biochemical analysis,
autoantibody, thyroid function, etc )
6) Prior chemotherapy or radiotherapy
7) Imaging characteristics of NSCLC on
CT prior to nivolumab monotherapy
8) Incidence of pseudoprogression
Independent variables
Overall survival, progression free
survival, objective response rate,
disease control rate
Study design
Retrospective study
Sampling methods
Consecutive sampling
Management information
Registered date
| 2017 | Year | 02 | Month | 24 | Day |
Last modified on
| 2021 | Year | 02 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030109
| Research Plan | |
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| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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