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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000033657
Receipt No. R000038370
Official scientific title of the study Prospective study of anti-PD-1 antibody therapy in advanced non-small cell lung cancer patients who previously treated with anti-PD-L1 antibody
Date of disclosure of the study information 2018/08/07
Last modified on 2018/08/07

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Basic information
Official scientific title of the study Prospective study of anti-PD-1 antibody therapy in advanced non-small cell lung cancer patients who previously treated with anti-PD-L1 antibody
Title of the study (Brief title) JRC-IO-B
Region
Japan

Condition
Condition lung cancer
Classification by specialty
Pneumology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Safety and efficacy predictors of anti-PD-1 treatment against anti-PD-L1 antibody treated previously advanced non-small cell lung cancer
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Response rate
Key secondary outcomes Progression free survival: PFS
Overall survival: OS
Disease control rate: DCR
Safety
Predictors

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. Non-small cell lung cancer patient confirmed by cytology or histology.
2. Patients who are refractory to or recurrence of anti-PD-L1 antibody therapy after the second-line treatment (in the case of post-surgical chemotherapy with anti-PD-L1 treatment, postoperative chemotherapy is treated as primary treatment). The history of use of cytotoxic agents and molecular targeted therapeutic agents is not limited. The expression rate of PD-L1 does not matter.
3. Age 20 years and over.
4. PS (ECOG): 0-2.
5. Patient with measurable lesion (RECIST 1.1).
6. There are no major obstacles to the main organs (bone marrow, heart, lung, liver, kidney etc.).
7. Surgery for primary lesion Patients who have had more than 14 days of radiation therapy after radical irradiation of recurrent patients or primary lesions after resection.
8. Pre-immune checkpoint inhibitor Patients who are more than 14 days old since the last administration.
9. Patient who gained consent from the patient to the treatment.
Key exclusion criteria 1. Patient whose administration of immune checkpoint inhibitor is contraindicated.
2. Patient with a history of cardiac function abnormality (acknowledging abnormality requiring treatment by electrocardiogram) or a history of myocardial infarction within 6 months before registration Patient with uncontrolled angina pectoris or heart failure.
Patients with active duplicated cancers (excluding carcinoma within the carcinoma and duplicate carcinoma with no recurrence for more than 5 years).
3. Cases with complications of infection or patients suspected of having infection with fever 38 degrees Celsius or higher.
4. Pregnant women, patients who may be pregnant, breastfeeding patients.
5. Other patients judged inappropriate by the attending physician due to serious complications.
Target sample size 30

Research contact person
Name of lead principal investigator Takehiro Izumo
Organization Japanese Red Cross Medical Center
Division name Respiratory Medicine
Address 4-1-22, Hiroo, Shibuya-ku, Tokyo, Japan
TEL 03-3400-1311
Email drtake111@gmail.com

Public contact
Name of contact person Takehiro Izumo
Organization Japanese Red Cross Medical Center
Division name Respiratory Medicine
Address 4-1-22, Hiroo, Shibuya-ku, Tokyo, Japan
TEL 03-3400-1311
Homepage URL
Email drtake111@gmail.com

Sponsor
Institute Japanese Red Cross Medical Center
Institute
Department

Funding Source
Organization Japanese Red Cross Medical Center
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

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 08 Month 07 Day

Progress
Recruitment status Open public recruiting
Date of protocol fixation
2018 Year 07 Month 01 Day
Anticipated trial start date
2018 Year 08 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
Other related information Single facility observational study

Management information
Registered date
2018 Year 08 Month 07 Day
Last modified on
2018 Year 08 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038370

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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