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

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 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


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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036280


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name