UMIN-CTR Clinical Trial

Basic information
Public title	The significance of changes in tumor hypoxia by anti-PD-1 / PD-L1 antibody therapy for advanced non-small cell lung cancer.
Acronym	Hypoxia and immunotherapy in lung cancer
Scientific Title	The significance of changes in tumor hypoxia by anti-PD-1 / PD-L1 antibody therapy for advanced non-small cell lung cancer.
Scientific Title:Acronym	Hypoxia and immunotherapy in lung cancer
Region	Japan

Condition
Condition	advanced non-small cell lung cancer
Classification by specialty	Pneumology Radiology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	Changes in FMISO uptake on PET before and after PD-1 blockade treatment
Basic objectives2	Others
Basic objectives -Others	none
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Change of SUVmax, MTV and TLG of FMISO accumulation on PET
Key secondary outcomes

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	Diagnosis
Type of intervention	Maneuver
Interventions/Control_1	We perform FMISO-PET before and 8 weeks after immune checkpoint inhibitor treatment
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.Patients diagnosed with advanced non-small cell lung cancer 2. Patients who are scheduled to be treated with immune checkpoint inhibitors (anti-PD-1/PD-L1 antibodies) 3. Patients over the age of 20 when consent is obtained 4.Patients undergoing FDG-PET for whole body search 5. Patients with measurable lesions 6. Patients who have major organ functions 7. Patients who have obtained informed consent for this study
Key exclusion criteria	1. Pregnant women, lactating women and women with the possibility or intention of becoming pregnant 2. Patients with complications that require intravenous administration of antibiotics and antifungal agents 3.Patients who need to administer systemic steroids and other immunosuppressive drugs 4. Patients with diabetes 5. In addition, patients who are judged as inappropriate by the doctor's judgment
Target sample size	20

Research contact person
Name of lead principal investigator	1st name Kosuke Middle name Last name Hashimoto
Organization	Saitama Medical University International Medical Center
Division name	Respiratory medicine
Zip code	350-1298
Address	1397-1 Yamane, Hidaka City, Saitama Prefecture
TEL	042-984-4177
Email	hkosuke@saitama-med.ac.jp

Public contact
Name of contact person	1st name Kosuke Middle name Last name Hashimoto
Organization	Saitama Medical University International Medical Center
Division name	Respiratory medicine
Zip code	350-1298
Address	1397-1 Yamane, Hidaka City, Saitama Prefecture
TEL	042-984-4177
Homepage URL
Email	hkosuke@saitama-med.ac.jp

Sponsor
Institute	Saitama Medical University International Medical Center
Institute
Department

Funding Source
Organization	Japan Science and Technology Agency
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	Saitama Medical University International Medical Center
Address	1397-1 Yamane, Hidaka City, Saitama Prefecture
Tel	042-984-4177
Email	hkosuke@saitama-med.ac.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	埼玉医科大学国際医療センター

Other administrative information
Date of disclosure of the study information	2020 Year 09 Month 03 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	Preinitiation
Date of protocol fixation	2020 Year 06 Month 25 Day
Date of IRB	2020 Year 08 Month 05 Day
Anticipated trial start date	2020 Year 09 Month 01 Day
Last follow-up date	2023 Year 03 Month 30 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 09 Month 02 Day
Last modified on	2020 Year 09 Month 01 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047512