UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040696 |
|---|---|
| Receipt number | R000046403 |
| Scientific Title | Phase II trial of anti-PD-1 therapy after anti-PD-L1 therapy in patients with unresectable locally advanced or advanced non-small-cell lung cancer |
| Date of disclosure of the study information | 2020/06/09 |
| Last modified on | 2021/03/31 18:45:53 |
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Basic information
Public title
Phase II trial of anti-PD-1 therapy after anti-PD-L1 therapy in patients with unresectable locally advanced or advanced non-small-cell lung cancer
Acronym
Phase II trial of anti-PD-1 therapy after anti-PD-L1 therapy
Scientific Title
Phase II trial of anti-PD-1 therapy after anti-PD-L1 therapy in patients with unresectable locally advanced or advanced non-small-cell lung cancer
Scientific Title:Acronym
Phase II trial of anti-PD-1 therapy after anti-PD-L1 therapy
Region
| Japan |
Condition
Condition
non-small-cell lung cancer
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
The objective of this study is to investigate efficacy and safety of anti-PD-1 therapy after anti-PD-L1 therapy in patients with unresectable locally advanced or advanced non-small-cell lung cancer.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
Overall response rate of anti-PD-1 therapy after anti-PD-L1 therapy
Key secondary outcomes
Progression free survival, overall survival, duration of response, safety
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Pembrolizumab (200mg/body q3w)or Nivolumab (240mg/body q2w)
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
Patients who meet the following criteria for each cohort and plan to receive atezolizumab;
Cohort A:
Subjects with histologically confrmed Stage IIIB/IV or recurrent NSCLC (UICC TNM 8th).
No history of the treatment of anti PD-L1, anti-CTLA-4 antibody or drugs of effect to T cell.
Cohort B:
Subjects with histologically confrmed Stage IIIB/IV or recurrent NSCLC (UICC TNM 8th).
Previous chemotherapy consisting of platinum.
No history of the treatment of anti PD-L1, anti-CTLA-4 antibody or drugs of effect to T cell.
Both cohort:
Without symptomatic brain metastasis, carcinomatous meningitis, and bone metastasis requiring radio therapy or surgery.
Without pericardial, pleural effusion, or ascites requiring the treatment.
Ages 20 <=years of age at registration.
ECOG Performance Status of <=1.
Measurable disease by CT or MRI per RECIST 1.1 criteria; radiographic tumor assessment performed within 28 days of registration.
Without a condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of registration.
Screening laboratory values must meet the following criteria (within 14 days of registration):
1. Neutrophil >= 1500 / mm3
2. Platelet >= 10 x 10^4 / mm3
3. Hb >= 8.0 g/dL
4. AST(GOT)<= 100 U/L
5. ALT(GPT)<= 100 U/L
6. Total bililubin <= 1.5 mg/dL.
SpO2 >= 90 within 14 days of registration.
Consent to contraception for at least 31 weeks after the final administration of treatment from the day of the consent
Subjects must have signed written informed consent form.
Key exclusion criteria
Subjects with an active infection requiring systemic treatment.
History of the treatment of anti PD-L1, anti-CTLA-4 antibody or drugs of effect to T cell.
Subjects with an active Gastrointestinal ulcer.
Subjects with past or present history of interstitial lung disease diagnosed by clinical or imaging findings.
History of allergy or hypersensitivity to study drug components.
Subjects with an active or refractory autoimmune disease. Subjects with type I diabetes mellitus, hypothyroidism only requiring hormone replacement, skin disorders not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll.
Known history of testing positive for HIV antibody, HBs antigen, HCV antibody and HCV-RNA. If HBs antibody or HBc antibody was positive, subjects testing negative for HBV-DNA is permitted to enroll.
Subjects who are or may be pregnant, or are breast-feeding.
Subjects with psychiatric illness.
Target sample size
75
Research contact person
Name of lead principal investigator
| 1st name | Hidehito |
| Middle name | |
| Last name | Horinouchi |
Organization
National cancer center hospital
Division name
Department of Thoracic Oncology
Zip code
104-0045
Address
5-1-1 Tsukiji Chuo-ku Tokyo
TEL
03-3542-2511
hhorinou@ncc.go.jp
Public contact
Name of contact person
| 1st name | Munehiro |
| Middle name | |
| Last name | Ito |
Organization
National cancer center hospital
Division name
Department of Thoracic Oncology
Zip code
104-0045
Address
5-1-1 Tsukiji Chuo-ku Tokyo
TEL
03-3542-2511
Homepage URL
muito@ncc.go.jp
Sponsor or person
Institute
National cancer center hospital
Institute
Department
Personal name
Funding Source
Organization
National cancer center hospital
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
National cancer center IRB
Address
5-1-1 Tsukiji Chuo-ku Tokyo
Tel
03-3542-2511
irst@ml.res.ncc.go.jp
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
| 2020 | Year | 06 | Month | 09 | 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
Terminated
Date of protocol fixation
| 2020 | Year | 05 | Month | 07 | Day |
Date of IRB
| 2020 | Year | 05 | Month | 08 | Day |
Anticipated trial start date
| 2020 | Year | 06 | Month | 09 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 06 | Month | 09 | Day |
Last modified on
| 2021 | 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=R000046403
