UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028561 |
|---|---|
| Receipt number | R000032567 |
| Scientific Title | A phase II study of Nivolumab re-challenge therapy in patients with advanced non-small cell lung cancer who responded to prior PD-1/L1 inhibitors (WJOG9616L) |
| Date of disclosure of the study information | 2017/08/08 |
| Last modified on | 2023/05/17 11:00:00 |
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Basic information
Public title
A phase II study of Nivolumab re-challenge therapy in patients with advanced non-small cell lung cancer who responded to prior PD-1/L1 inhibitors (WJOG9616L)
Acronym
Nivolumab re-challenge study (WJOG9616L)
Scientific Title
A phase II study of Nivolumab re-challenge therapy in patients with advanced non-small cell lung cancer who responded to prior PD-1/L1 inhibitors (WJOG9616L)
Scientific Title:Acronym
Nivolumab re-challenge study (WJOG9616L)
Region
| Japan |
Condition
Condition
Pre-treated lung cancer
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy of nivolumab in NSCLC patients those who were benefit from prior PD-1/L1 inhibitors.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
To evaluate the efficacy of nivolumab in NSCLC patients those who were benefit from prior PD-1/L1 inhibitors.
Key secondary outcomes
Disease control rate, progression-free survival, overall survival, safety
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 240mg/body, 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. Pathologically proven NSCLC
2. Clinical stage IIIB, C, IV, or post-operative relapse based on the classification of Lung Cancer ver8
3. Without symptomatic brain metastasis
4. With targetable lesion based on RECIST ver1.1
5. Those who were benefit from PD-1/L1 monotherapy such as CR, PR, SD lasting more than 6 months
6. ECOG PS of 0-1
Key exclusion criteria
1. Prior history of serious immune related adverse event
2. With active auto-immune disease
3. With interstitial lung disease confirmed by chest CT
4. Those receive steroid therapy more than prednisolone more than 10mg/day
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Shunsuke |
| Middle name | |
| Last name | Teraoka |
Organization
Wakayama Medical Univercity
Division name
Respiratory Medicine and Clinical Oncology
Zip code
641-8509
Address
811-1, Kimiidera, Wakayama-city
TEL
073-447-2300
teraoka@wakayama-med.ac.jp
Public contact
Name of contact person
| 1st name | Shinichiro |
| Middle name | |
| Last name | Nakamura |
Organization
West Japan Oncology Group
Division name
WJOG datacenter
Zip code
556-0016
Address
Namba Plaza Bldg. 304-1-5-7, Motomachi Naniwa-ku, Osaka 556-0016 JAPAN
TEL
06-6633-7400
Homepage URL
datacenter@wjog.jp
Sponsor or person
Institute
West Japan Oncology Group
Institute
Department
Personal name
Funding Source
Organization
Ono Pharmatheutical co.Bristol Meiyers Squibb
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
Wakayama Medical University Certified Review Board
Address
811-1 Kimiidera, Wakayama, Wakayama Prefecture 641-8509, Japan
Tel
073-441-0896
wa-rinri@wakayama-med.ac.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
jRCTs051180019
Org. issuing International ID_1
Ministry of Health, Labour and Welfare
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 | 08 | Month | 08 | Day |
Related information
URL releasing protocol
https://jrct.niph.go.jp/latest-detail/jRCTs051180019
Publication of results
Published
Result
URL related to results and publications
https://pubmed.ncbi.nlm.nih.gov/35617519/
Number of participants that the trial has enrolled
61
Results
The primary endpoint was not met.
Results date posted
| 2023 | Year | 05 | Month | 17 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2022 | Year | 05 | Month | 26 | Day |
Baseline Characteristics
Advanced NSCLC patients who responded to prior PD-1/L1 inhibitors.
Participant flow
Sixty-one patients were included between Oct 2017 and Feb 2020.
Adverse events
There was no treatment related death. Severe adverse events leading to hospitalization were 11 cases. Nine cases were reported to be recovered and two cases which were not reported to be recovered were not related to study treatment.
Outcome measures
ORR 8.5% 95%CI 2.8-18.7%
DCR 50.8% 95%CI 37.5-64.1%
PFS median 2.6 months 95%CI 1.6-2.8
OS median 11.0 months 95%CI 9.0-14.5
Safety Grade 3-5 Adverse Event 20%
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2017 | Year | 08 | Month | 06 | Day |
Date of IRB
| 2017 | Year | 09 | Month | 07 | Day |
Anticipated trial start date
| 2017 | Year | 10 | Month | 17 | Day |
Last follow-up date
| 2021 | Year | 08 | 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
| 2017 | Year | 08 | Month | 07 | Day |
Last modified on
| 2023 | Year | 05 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032567
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