UMIN-CTR Clinical Trial

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
Last 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
1st 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