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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000030782
Receipt No. R000035143
Scientific Title Phase II study for efficacy and safety of pembrolizumab for the cytotoxic chemotherapy unfit previously untreated or treated PD-L1 positive advanced non-small cell lung cancer
Date of disclosure of the study information 2018/01/12
Last modified on 2019/03/22

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Basic information
Public title Phase II study for efficacy and safety of pembrolizumab for the cytotoxic chemotherapy unfit previously untreated or treated PD-L1 positive advanced non-small cell lung cancer
Acronym Phase II study of pembrolizumab for advanced NSCLC patients with poor PS
Scientific Title Phase II study for efficacy and safety of pembrolizumab for the cytotoxic chemotherapy unfit previously untreated or treated PD-L1 positive advanced non-small cell lung cancer
Scientific Title:Acronym Phase II study of pembrolizumab for advanced NSCLC patients with poor PS
Region
Japan

Condition
Condition PD-L1 positive previously treated advanced non-small-cell lung cancer
Classification by specialty
Pneumology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To explore the efficacy and safety of nivolumab for PD-L1 positive previously untreated or treated advanced lung cancer patients who have no indication for standard chemotherapy, including cytotoxic chemotherapy and molecular targeted therapy
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Phase II

Assessment
Primary outcomes Response rate
Key secondary outcomes Progression-free survival, Overall survival, and Toxicity.

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification NO
Dynamic allocation NO
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Pembrolizumab 200mg (day 1, q3 weeks) until clinical progression or unacceptable toxicities for two years.
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 1) Definitively diagnosed with having PD-L1 positive previously untreated or treated advanced non-small cell lung cancer by the specimens histologically or cytologically who have no indication for standard treatment of chemotherapy including cytotoxic chemotherapy and molecular targeted agents for driver mutation.
2) Age of 20 years and older
3) With adequate organ function of bone marrow reserve, liver, and kidney.
(1) PS 2-4
(2) neutrophil count => 500/mm^3
(3) platelet => 50,000/mm^3
(4) hemoglobin => 6.5g/dL
(5) AST/ALT < 5 times less than ULN
(6) T.Bil <= 3.0mg/dL
(7) serum creatinine <= 3.0mg/dL
(8) ECG: without clinically problematic abnormalities
(9) SpO2 more than 92% (O2 < 2L/min)
4) With the status of below previous treatment at the time of beginning of chemotherapy.
(1) Radiotherapy: irradiated extrathoracic lesion: more than two weeks from the date of last irradiation
(2) Surgical procedure, including pleurodesis or pleural drainage
* more than 8 weeks with lobectomy
* more than 4 weeks without lobectomy, including exploratory thoracotomy
* more than 2 weeks after completing procedure (pleurodesis or pleural drainage)
5) With written informed consent
Key exclusion criteria 1) The age of less than 20
2) Indicative for cytotoxic chemotherapy or molecular targeted agents
3) Uncontrolled brain metastasis treated by palliative radiotherapy
4) Clinically active infection
5) Severe complication (cardiac diseases, interstitial pneumonia, uncontrolled hypertension or diabetes)
6) Uncontrolled pleural effusion
7) Active other organ cancers
8) History of severe drug allergy
9) Uncontrolled digestive ulcer
10) Any patients judged by the investigator to be unfit to participate in the study
Target sample size 32

Research contact person
Name of lead principal investigator
1st name Yukio
Middle name
Last name Hosomi
Organization Tokyo Metropolitan Cancer and Infectious disease Center Komagome Hospital
Division name epartment of Respiratory Medicine and Thoracic Oncology
Zip code 113-8677
Address 3-18-22, Honkomagome, Bunkyo, Tokyo
TEL 03-3823-2101
Email yhosomi@cick.jp

Public contact
Name of contact person
1st name Yusuke
Middle name
Last name Okuma
Organization Tokyo Metropolitan Cancer and Infectious disease Center Komagome Hospital
Division name Department of Respiratory Medicine and Thoracic Oncology
Zip code 113-8677
Address 3-18-22, Honkomagome, Bunkyo, Tokyo
TEL 03-3823-2101
Homepage URL
Email y-okuma@cick.jp

Sponsor
Institute Department of Respiratory Medicine and Thoracic Oncology, Tokyo Metropolitan Cancer and Infectious disease Center Komagome Hospital
Institute
Department

Funding Source
Organization Department of Respiratory Medicine and Thoracic Oncology, Tokyo Metropolitan Cancer and Infectious disease Center Komagome Hospital
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Ethics committee of Tokyo Metropolitan Komagome Hospital
Address 3-28-22, Honkomagome, Bunkyo, Tokyo
Tel 03-3823-2101
Email rinri@cick.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 がん・感染症センター都立駒込病院

Other administrative information
Date of disclosure of the study information
2018 Year 01 Month 12 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 Enrolling by invitation
Date of protocol fixation
2017 Year 05 Month 01 Day
Date of IRB
2017 Year 05 Month 01 Day
Anticipated trial start date
2018 Year 01 Month 11 Day
Last follow-up date
2022 Year 02 Month 28 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 01 Month 12 Day
Last modified on
2019 Year 03 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035143

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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