UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031888 |
|---|---|
| Receipt number | R000036280 |
| Scientific Title | Prospective pilot study of anti-PD-L1 antibody therapy in advanced non-small cell lung cancer patients who previously responded to anti-PD-1 antibody |
| Date of disclosure of the study information | 2018/04/01 |
| Last modified on | 2020/03/31 21:38:30 |
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Basic information
Public title
Prospective pilot study of anti-PD-L1 antibody therapy in advanced non-small cell lung cancer patients who previously responded to anti-PD-1 antibody
Acronym
Prospective pilot study of anti-PD-L1 antibody therapy in advanced non-small cell lung cancer patients who previously responded to anti-PD-1 antibody
Scientific Title
Prospective pilot study of anti-PD-L1 antibody therapy in advanced non-small cell lung cancer patients who previously responded to anti-PD-1 antibody
Scientific Title:Acronym
Prospective pilot study of anti-PD-L1 antibody therapy in advanced non-small cell lung cancer patients who previously responded to anti-PD-1 antibody
Region
| Japan |
Condition
Condition
advanced non-small cell lung cancer
Classification by specialty
| Pneumology | Adult |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Study the effectiveness of anti-PD-L1 antibody therapy in advanced non-small cell lung cancer patients who previously responded to anti-PD-1 antibody.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Progression-free survival
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
More than 3 months have passed from anti-PD-1 antibody therapy termination (including patients using primary therapeutic pembrolizumab) in patients with advanced stage non-small cell lung cancer.
Patients with the most excellent effect of anti-PD-1 antibody are CR, PR, SD (patients with SD or higher effect).
Basic organ function is maintained
Prognosis of more than 3 months is expected at registration
Key exclusion criteria
1. Patients with a history of complication of autoimmune disease or chronic or recurrent autoimmune disease.
* However, patients whose condition is controlled by replacement therapy such as chronic thyroiditis and type I diabetes are not excluded.
2. Patients with active or symptomatic interstitial pneumonia.
3. Patients with infectious diseases requiring systemic treatment.
4. Patients who are merging psychosis or psychiatric symptoms and are considered difficult to participate in the study.
5. Patients with symptomatic brain metastases.
* However, clinically stable brain metastasis cases can be registered.
6. Patients complicated of poor control diabetes.
7. Patients with severe complications (heart of poor control, lungs, liver, kidney disease etc.)
8. Patients with active liver disease (HBV DNA positive, alcoholic hepatitis, autoimmune hepatitis, liver cirrhosis etc.)
* If HBs antigen positive, HBs antibody positive, HBc antibody positive, measure HBV DNA. Exclude cases where HBV DNA is positive.
9. Patients who are undergoing systemic administration of steroid for at least 4 weeks at the time of registration.
* However, steroids within 10 mg / day in terms of prednisolone are acceptable.
10. Male without intention to contraception. Or pregnant women, lactating women, women who are positive for pregnancy tests or women who are not willing to contraception.
11. Patients with a history of severe hypersensitivity.
12.Patients who are judged by the investigator or shared medical doctor to be inappropriate for participating in this study.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takahiro Uchida |
Organization
Saitama medical university International medical Center
Division name
Department of Respiratory medicine
Zip code
Address
1397-1 Yamane, Hidaka-shi, Saitama-ken
TEL
0429-84-4111
uchitaka@saitama-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takahiro Uchida |
Organization
Saitama medical university International medical Center
Division name
Department of Respiratory medicine
Zip code
Address
1397-1 Yamane, Hidaka-shi, Saitama-ken
TEL
0429-84-4111
Homepage URL
uchitaka@saitama-med.ac.jp
Sponsor or person
Institute
Saitama medical university International medical Center
Institute
Department
Personal name
Funding Source
Organization
Saitama medical university International medical Center
Organization
Division
Category of Funding Organization
Other
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 | 04 | 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
Completed
Date of protocol fixation
| 2018 | Year | 03 | Month | 01 | Day |
Date of IRB
| 2018 | Year | 06 | Month | 30 | Day |
Anticipated trial start date
| 2018 | Year | 06 | Month | 30 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 11 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
prospective pilot study
Management information
Registered date
| 2018 | Year | 03 | Month | 25 | Day |
Last modified on
| 2020 | Year | 03 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036280
