UMIN-CTR Clinical Trial

Basic information
Public title	Efficacy and safety of irinotecan after chemotherapy in combination with immunotherapy in patients with extensive stage small cell lung cancer: a phase II trial
Acronym	Efficacy and safety of irinotecan after chemotherapy in combination with immunotherapy in patients with extensive stage small cell lung cancer: a phase II trial
Scientific Title	Efficacy and safety of irinotecan after chemotherapy in combination with immunotherapy in patients with extensive stage small cell lung cancer: a phase II trial
Scientific Title:Acronym	Efficacy and safety of irinotecan after chemotherapy in combination with immunotherapy in patients with extensive stage small cell lung cancer: a phase II trial
Region	Japan

Condition
Condition	Extensive stage small cell lung cancer
Classification by specialty	Pneumology Hematology and clinical oncology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	Efficacy and safety of nab-paclitaxel monotherapy in patients with non-small cell lung cancer immediately after chemotherapy in combination with immunotherapy.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase	Phase II

Assessment
Primary outcomes	Objective response rate
Key secondary outcomes	Progression-free survival, disease control rate, overall survival, and safety. Subset analysis of efficacy stratified by smoking history and objective response of previous treatment.

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	Irinotecan monotherapy
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) Pathologically or cytologically confirmed extensive stage small cell lung cancer (SCLC). 2) Patients who received immunotherapy in combination with chemotherapy for their first line treatment. 3) Within 8 weeks after end of first line treatment. 4) Patient with evaluable lesion based on RECIST. 5) Age 20 or over. 6) Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2. 7) No severe organ dysfunction and laboratory data fulfill the standards. 8) Three months and more survival is expected. 9) Written informed consent.
Key exclusion criteria	1) Patients who previously treated with irinotecan 2) Patients with homozygous polymorphisms for UGT1A1*28 and *6 (*28/*28, *6/*6, and *6/*28) 3) Diarrhea (grade 1 or more) before the treatment. 4) Uncontrolable pleural or pericardial effusion. 5) Within 2 weeks after radiotherapy. 6) Operation within 4 weeks. 7) Active double cancer. 8) Active infectious disease. 9) Severe complications including heart failure, hepatic failure, renal failure, paresis of intestine, and ileus. 10) Pregnant woman. 11) HBs antigen positive. 12) Patients who received systemic corticosteroid (10mg or more prednisolone conversion). 13) The subjects whom the doctor excluded.
Target sample size	22

Research contact person
Name of lead principal investigator	1st name Yukihiro Middle name Last name Umeda
Organization	University of Fukui
Division name	Third department of internal medicine
Zip code	910-1193
Address	23-3, Matsuokashimoaizuki, Eiheiji-cho, Yoshida-gun, Fukui, Japan
TEL	+81776613111
Email	umeda@u-fukui.ac.jp

Public contact
Name of contact person	1st name Yukihiro Middle name Last name Umeda
Organization	University of Fukui
Division name	Third department of internal medicine
Zip code	910-1193
Address	23-3, Matsuokashimoaizuki, Eiheiji-cho, Yoshida-gun, Fukui, Japan
TEL	+81776613111
Homepage URL
Email	umeda@u-fukui.ac.jp

Sponsor
Institute	Third department of internal medicine, Universtiy of Fukui
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor	Japanese Red Cross Fukui Hospital, Municipal Tsuruga Hospital
Name of secondary funder(s)

IRB Contact (For public release)
Organization	The Research Ethics Committee of University of Fukui
Address	23-3, Matsuokashimoaizuki, Eiheiji-cho, Fukui, Japan
Tel	0776-61-3111
Email	smsien-k@ad.u-fukui.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	福井大学医学部附属病院（福井県）、福井赤十字病院（福井県）、市立敦賀病院（福井県）

Other administrative information
Date of disclosure of the study information	2021 Year 01 Month 05 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	2021 Year 01 Month 15 Day
Date of IRB	2020 Year 12 Month 21 Day
Anticipated trial start date	2021 Year 01 Month 15 Day
Last follow-up date	2024 Year 09 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	2021 Year 01 Month 04 Day
Last modified on	2021 Year 01 Month 05 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048960

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name

Contact us.