UMIN-CTR Clinical Trial

Basic information
Public title	Efficacy and safety of immune checkpoint inhibitors alone or in combination with chemotherapy in pulmonary sarcomatoid carcinoma
Acronym	Efficacy and safety of immune checkpoint inhibitors alone or in combination with chemotherapy in pulmonary sarcomatoid carcinoma
Scientific Title	Efficacy and safety of immune checkpoint inhibitors alone or in combination with chemotherapy in metastatic pulmonary sarcomatoid carcinoma: a retrospective cohort study
Scientific Title:Acronym	Efficacy and safety of immune checkpoint inhibitors alone or in combination with chemotherapy in metastatic pulmonary sarcomatoid carcinoma: a retrospective cohort study
Region	Japan

Condition
Condition	Pulmonary sarcomatoid carcinoma
Classification by specialty	Pneumology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the efficacy and safety of immune checkpoint inhibitors(ICI) alone or in combination with chemotherapy in metastatic pulmonary sarcomatoid carcinoma(PSC).
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Overall Response Rate, Progression Free Survival
Key secondary outcomes

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) Patients with histologically or cytologically proven PSC (2) Patients with stage IIIB/IIIC/IV or postoperative recurrence (3) Patients who received ICI alone or in combination with chemotherapy (4) Patients aged 20 years or older at the time of diagnosis
Key exclusion criteria	(1)Patients who chose not to participate in the study (2)Patients who received ICI as previous therapy
Target sample size	150

Research contact person
Name of lead principal investigator	1st name Motoko Middle name Last name Tachihara
Organization	Kobe University Graduate School of Medicine
Division name	Division of Respiratory Medicine, Department of Internal Medicine
Zip code	650-0017
Address	7-5-1 Kusunoki-cho, Chuo-ku, Kobe City
TEL	078-382-5660
Email	mt0318@med.kobe-u.ac.jp

Public contact
Name of contact person	1st name Daisuke Middle name Last name Hazama
Organization	Kobe University Graduate School of Medicine
Division name	Division of Respiratory Medicine, Department of Internal Medicine
Zip code	650-0017
Address	7-5-1 Kusunoki-cho, Chuo-ku, Kobe City
TEL	078-382-5660
Homepage URL
Email	dhazama@med.kobe-u.ac.jp

Sponsor
Institute	Kobe University
Institute
Department

Funding Source
Organization	Division of Respiratory Medicine, Department of Internal Medicine, Kobe University Graduate School of Medicine
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	Kobe University Hospital Clinical and Translational Research Center
Address	7-5-2 Kusunoki-cho, Chuo-ku, Kobe City
Tel	078-382-6669
Email	kansatsu@med.kobe-u.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

Other administrative information
Date of disclosure of the study information	2022 Year 01 Month 01 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	124
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	No longer recruiting
Date of protocol fixation	2021 Year 11 Month 07 Day
Date of IRB	2022 Year 01 Month 31 Day
Anticipated trial start date	2022 Year 02 Month 01 Day
Last follow-up date	2022 Year 10 Month 31 Day
Date of closure to data entry
Date trial data considered complete	2022 Year 05 Month 17 Day
Date analysis concluded

Other

Other related information

1) Age, Sex, ECOG PS, Histopathological subtype, Method of diagnosis, Genomic alterations, Clinical staging, PD-L1 expression, Smoking status, Autoimmune diseases, Steroids or immunosuppressive agents at treatment initiation, History of thoracic radiotherapy 2) CT, MRI and PET-CT before treatment, Measurable lesion, Brain metastases, Liver metastases, Interstitial lung disease 3) Treatment regimen, Date of treatment initiation, Best over-all response, Date of best response, The last date of progression free follow-up, Date of treatment discontinuation, Reason for treatment discontinuation, Incidence and the worst grade of Immune-related Adverse Drug Reaction, The last date of survival follow-up, cause of death

Management information
Registered date	2021 Year 11 Month 07 Day
Last modified on	2022 Year 11 Month 08 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000052421