UMIN-CTR Clinical Trial

Recruitment status Completed
Unique ID issued by UMIN UMIN000032667
Receipt No. R000037247
Scientific Title Retrospective observational study of salvage chemotherapy following nivolumab therapy in advanced non-small cell lung cancer
Date of disclosure of the study information 2018/06/01
Last modified on 2019/05/22 (Ver. 8)

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Basic information
Public title Retrospective observational study of salvage chemotherapy following nivolumab therapy in advanced non-small cell lung cancer
Acronym Retrospective exploratory study of salvage chemotherapy for nivolumab-refractory lung cancer
Scientific Title Retrospective observational study of salvage chemotherapy following nivolumab therapy in advanced non-small cell lung cancer
Scientific Title:Acronym Retrospective exploratory study of salvage chemotherapy for nivolumab-refractory lung cancer
Region
Japan

Condition
Condition non-small cell lung cancer
Classification by specialty
Pneumology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study is to clarify the anti-tumor activity in lung cancer patients receiving salvage chemotherapy following nivolumab therapy and investigate the tumor immune microenvironment.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes The primary endpoint is overall response of salvage chemotherapy in association with the characteristics of tumor-infiltrating immune cells.
Key secondary outcomes The secondary endpoint is progression-free survival of salvage chemotherapy,

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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Ww enroll the patients with relapsed or advanced non-small cell lung cancer who underwent salvage chemotherapy following progression after conventional cytotoxic chemotherapy and the subsequent nivolumab therapy.
Key exclusion criteria The patients are excluded from the analysis if they had another neoplasm for the need of treatment, and if they received the preceding therapy of EGFR or ALK throsine kinase inhibitors before or after nivolumab therapy.
Target sample size 10

Research contact person
Last name of lead principal investigator
1st name HIroshi
Middle name
Last name Soda
Organization Sasebo City General Hospital
Division name Department of Respiratory Medicine
Zip code 857-8511
Address 9-3, Hirase, Sasebo, Nagasaki, Japan
TEL 0956-24-1515
Email h-souda@hospital.sasebo.nagasaki.jp

Public contact
1st name of contact person
1st name Hiroshi
Middle name
Last name Soda
Organization Sasebo City General Hospital
Division name Department of Respiratory Medicine
Zip code 857-8511
Address 9-3, Hirase, Sasebo, Nagasaki, Japan
TEL 0956-24-1515
Homepage URL
Email h-souda@hospital.sasebo.nagasaki.jp

Sponsor
Institute Department of Respiratory Medicine, Sasebo City General Hospital
Institute
Department

Funding Source
Organization Self-funding
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 Sasebo City General Hospital
Address 9-3, Hirase, Sasebo, Nagasaki, 857-8511
Tel 0956-24-1515
Email c-jimusitsu@hospital.sasebo.nagasaki.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 佐世保市総合医療センター（長崎県）

Other administrative information
Date of disclosure of the study information
2018 Year 06 Month 01 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications https://www.ncbi.nlm.nih.gov/pubmed/30126069
Number of participants that the trial has enrolled 15
Results 
Both few PD-1 positive immune cells in the tumor and decreased NLR ratio during the treatment may predict the improved response to salvage chemotherapy following nivolumab for lung cancer.
Results date posted
2019 Year 05 Month 22 Day
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 Completed
Date of protocol fixation
2018 Year 04 Month 01 Day
Date of IRB
2018 Year 05 Month 31 Day
Anticipated trial start date
2018 Year 06 Month 01 Day
Last follow-up date
2018 Year 11 Month 01 Day
Date of closure to data entry
2018 Year 11 Month 01 Day
Date trial data considered complete
2018 Year 12 Month 31 Day
Date analysis concluded
2019 Year 03 Month 31 Day

Other
Other related information Retrospective observational study (Case-series analysis)

Management information
Registered date
2018 Year 05 Month 21 Day
Last modified on
2019 Year 05 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000037247