UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Prospective study of anti-PD-1 antibody therapy in advanced non-small cell lung cancer patients who previously treated with anti-PD-L1 antibody
Title of the study (Brief title)	JRC-IO-B
Region	Japan

Condition
Condition	lung cancer
Classification by specialty	Pneumology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	Safety and efficacy predictors of anti-PD-1 treatment against anti-PD-L1 antibody treated previously advanced non-small cell lung cancer
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Response rate
Key secondary outcomes	Progression free survival: PFS Overall survival: OS Disease control rate: DCR Safety Predictors

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	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1. Non-small cell lung cancer patient confirmed by cytology or histology. 2. Patients who are refractory to or recurrence of anti-PD-L1 antibody therapy after the second-line treatment (in the case of post-surgical chemotherapy with anti-PD-L1 treatment, postoperative chemotherapy is treated as primary treatment). The history of use of cytotoxic agents and molecular targeted therapeutic agents is not limited. The expression rate of PD-L1 does not matter. 3. Age 20 years and over. 4. PS (ECOG): 0-2. 5. Patient with measurable lesion (RECIST 1.1). 6. There are no major obstacles to the main organs (bone marrow, heart, lung, liver, kidney etc.). 7. Surgery for primary lesion Patients who have had more than 14 days of radiation therapy after radical irradiation of recurrent patients or primary lesions after resection. 8. Pre-immune checkpoint inhibitor Patients who are more than 14 days old since the last administration. 9. Patient who gained consent from the patient to the treatment.
Key exclusion criteria	1. Patient whose administration of immune checkpoint inhibitor is contraindicated. 2. Patient with a history of cardiac function abnormality (acknowledging abnormality requiring treatment by electrocardiogram) or a history of myocardial infarction within 6 months before registration Patient with uncontrolled angina pectoris or heart failure. Patients with active duplicated cancers (excluding carcinoma within the carcinoma and duplicate carcinoma with no recurrence for more than 5 years). 3. Cases with complications of infection or patients suspected of having infection with fever 38 degrees Celsius or higher. 4. Pregnant women, patients who may be pregnant, breastfeeding patients. 5. Other patients judged inappropriate by the attending physician due to serious complications.
Target sample size	30

Research contact person
Name of lead principal investigator	Takehiro Izumo
Organization	Japanese Red Cross Medical Center
Division name	Respiratory Medicine
Address	4-1-22, Hiroo, Shibuya-ku, Tokyo, Japan
TEL	03-3400-1311
Email	drtake111@gmail.com

Public contact
Name of contact person	Takehiro Izumo
Organization	Japanese Red Cross Medical Center
Division name	Respiratory Medicine
Address	4-1-22, Hiroo, Shibuya-ku, Tokyo, Japan
TEL	03-3400-1311
Homepage URL
Email	drtake111@gmail.com

Sponsor
Institute	Japanese Red Cross Medical Center
Institute
Department

Funding Source
Organization	Japanese Red Cross Medical Center
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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

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 08 Month 07 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2018 Year 07 Month 01 Day
Anticipated trial start date	2018 Year 08 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	Single facility observational study

Management information
Registered date	2018 Year 08 Month 07 Day
Last modified on	2018 Year 08 Month 07 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038370