UMIN-CTR Clinical Trial

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
Email	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
Email	muito@ncc.go.jp

Sponsor
Institute	National cancer center hospital
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046403