UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033288 |
|---|---|
| Receipt number | R000037867 |
| Scientific Title | Prospective study of anti-PD-L1 antibody therapy in advanced non-small cell lung cancer patients who previously treated with anti-PD-1 antibody |
| Date of disclosure of the study information | 2018/07/05 |
| Last modified on | 2018/07/05 08:48:29 |
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Basic information
Public title
Prospective study of anti-PD-L1 antibody therapy in advanced non-small cell lung cancer patients who previously treated with anti-PD-1 antibody
Acronym
JRC-IO-A
Scientific Title
Prospective study of anti-PD-L1 antibody therapy in advanced non-small cell lung cancer patients who previously treated with anti-PD-1 antibody
Scientific Title:Acronym
JRC-IO-A
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-L1 treatment against anti-PD-1 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-1 antibody therapy after the second-line treatment (in the case of post-surgical chemotherapy with anti-PD-1 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
| 1st name | |
| Middle name | |
| Last name | Takehiro Izumo |
Organization
Japanese Red Cross Medical Center
Division name
Respiratory Medicine
Zip code
Address
4-1-22, Hiroo, Shibuya-ku, Tokyo, Japan
TEL
03-3400-1311
drtake111@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takehiro Izumo |
Organization
Japanese Red Cross Medical Center
Division name
Respiratory Medicine
Zip code
Address
4-1-22, Hiroo, Shibuya-ku, Tokyo, Japan
TEL
03-3400-1311
Homepage URL
drtake111@gmail.com
Sponsor or person
Institute
Japanese Red Cross Medical Center
Institute
Department
Personal name
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)
IRB Contact (For public release)
Organization
Address
Tel
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 | 07 | Month | 05 | 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
| 2018 | Year | 05 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 07 | Month | 05 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Single facility observational study
Management information
Registered date
| 2018 | Year | 07 | Month | 05 | Day |
Last modified on
| 2018 | Year | 07 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037867
