UMIN-CTR Clinical Trial

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
Email	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
Email	uchitaka@saitama-med.ac.jp

Sponsor
Institute	Saitama medical university International medical Center
Institute
Department

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
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	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000036280