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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000038413
Receipt No. R000043696
Scientific Title Prospective multicenter observation study of anti-PD-1/PD-L1 antibody re-treatment who previously treated with anti-PD-1/PD-L1 antibody plus chemotherapy
Date of disclosure of the study information 2019/11/01
Last modified on 2019/10/27

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Basic information
Public title Prospective multicenter observation study of anti-PD-1/PD-L1 antibody re-treatment who previously treated with anti-PD-1/PD-L1 antibody plus chemotherapy
Acronym NJLCG1901 Prospective multicenter observation study of anti-PD-1/PD-L1 antibody re-treatment who previously treated with anti-PD-1/PD-L1 antibody plus chemotherapy
Scientific Title Prospective multicenter observation study of anti-PD-1/PD-L1 antibody re-treatment who previously treated with anti-PD-1/PD-L1 antibody plus chemotherapy
Scientific Title:Acronym NJLCG1901 Prospective multicenter observation study of anti-PD-1/PD-L1 antibody re-treatment who previously treated with anti-PD-1/PD-L1 antibody plus chemotherapy
Region
Japan

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

Objectives
Narrative objectives1 To evaluate efficacy and safety of anti-PD-1/PD-L1 antibody re-treatment who previously treated with anti-PD-1/PD-L1 antibody plus chemotherapy
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Overall Response Rate
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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1) Histologically or cytologically confirmed non-small cell lung cancer
2) Unresectable, locally advanced or metastatic non-small cell lung cancer
3) Patients with driver mutation/translocation negative or unknown
4) Patients who have worsened after the use of anti-PD-1/PD-L1 antibody plus chemotherapy for first-line treatment
5) 1 or 2 regimen as previous regimen (not include neoadjuvant chemotherapy or adjuvant chemotherapy)
6) Patients who are scheduled to start anti-PD-1/PD-L1 antibody re-treatment
7) At least one measurable lesion according to RECIST ver1.1 (within 28 days before enrollment)
8) Patients not younger than 20 years old at the time of informed consent
9) Life expectancy of at least 3 months
10) Patients providing written informed consent
Key exclusion criteria 1) Active double cancer
2) Patients with a history of severe immune-related adverse events associated with anti-PD-1/PD-L1 antibody
3) Patients with active autoimmune disease
4) Patients with infectious disease requiring systemic treatment
5) Radiographically confirmed interstitial pneumonitis or pulmonary fibrosis
6) Patients with significant complications
7) Patiens who are undergoing systemic administration of
steroid greater than 10mg daily of prednisone
8) History or severe drug allergies
9) Pregnant females, possibly pregnant females, females wishing to become pregnant, females of breastfeeding and males wishing to their partner's pregnant
10) Physician concludes that the patient's participation is inappropriate
Target sample size 70

Research contact person
Name of lead principal investigator
1st name Shunichi
Middle name
Last name Sugawara
Organization Sendai Kousei Hospital
Division name Department of pulmonary medicine
Zip code 9800873
Address 4-15 Hirosemachi, Aobaku, Sendai, Miyagi
TEL 022-222-6181
Email swara357@sendai-kousei-hospital.jp

Public contact
Name of contact person
1st name Yosuke
Middle name
Last name Kawashima
Organization Sendai Kousei Hospital
Division name Department of pulmonary medicine
Zip code 9800873
Address 4-15 Hirosemachi, Aobaku, Sendai, Miyagi
TEL 022-222-6181
Homepage URL
Email yousukekawashima3@yahoo.co.jp

Sponsor
Institute North Japan Lung Cancer Study Group
Institute
Department

Funding Source
Organization None
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 -
Address -
Tel -
Email -

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
2019 Year 11 Month 01 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
2019 Year 10 Month 20 Day
Date of IRB
2019 Year 10 Month 16 Day
Anticipated trial start date
2019 Year 10 Month 27 Day
Last follow-up date
2022 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information None

Management information
Registered date
2019 Year 10 Month 28 Day
Last modified on
2019 Year 10 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043696

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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