UMIN-CTR Clinical Trial

Basic information
Public title	A prospective observational study of pembrolizumab and chemotherapy for lung cancer patients with interstitial abnormalities
Acronym	Pembrolizumab and chemotherapy for lung cancer patients with interstitial abnormalities
Scientific Title	A prospective observational study of pembrolizumab and chemotherapy for lung cancer patients with interstitial abnormalities
Scientific Title:Acronym	Pembrolizumab and chemotherapy for lung cancer patients with interstitial abnormalities
Region	Japan

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

Objectives
Narrative objectives1	To evaluate for probability of pneumonitis in advanced non-small cell lung cancer patients with interstitial lung abnormalities treated with pembrolizumab plus platinum-based chemotherapy.
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The probability of pneumonitis in treatment of pembrolizumab plus platinum-based chemotherapy
Key secondary outcomes	1) Objective response rate 2) Disease control rate 3) Relapse free survival 4) Severity of pneumonitis 5) Provability of pneumonitis during observation period 6) Time to occurrence of pneumonitis 7) Probability of occurrence of adverse events

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 aged over 20 years old 2)Advanced or postoperative recurrence non-small cell lung cancer 3)Pembrolizumab plus platinum combination chemotherapy is planned as clinical practice. 4)The proportion of linear shadows, reticular abnormalities, or ground-glass abnormalities are less than 10% of all lung fields. 5) Written informed consent is obtained.
Key exclusion criteria	1)Patients with history of drug induced pneumonitis. 2)Patients who has increased infiltration other than lung cancer within 1 month. 3)Patients with interstitial pneumonitis with UIP pattern on computed tomography. 4)Patients with interstitial pneumonitis associated with collagen diseases. 5)Pregnant women and patients who may be pregnant or breastfeeding. 6)Patients who are judged to be inappropriate for the study by the investigator.
Target sample size	10

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, Japan
TEL	81-78-382-5661
Email	mt0318@med.kobe-u.ac.jp

Public contact
Name of contact person	1st name Naoko Middle name Last name Katsurada
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, Japan
TEL	81-78-382-5661
Homepage URL
Email	nk1208@med.kobe-u.ac.jp

Sponsor
Institute	Kobe University Graduate School of Medicine
Institute
Department

Funding Source
Organization	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	Institutional Review Board, Kobe University Hospital Clinical Translational Research Center
Address	7-5-2 Kusunoki-cho, Chuo-ku, Kobe, Japan
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	2019 Year 11 Month 21 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	2
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	Terminated
Date of protocol fixation	2019 Year 11 Month 15 Day
Date of IRB	2019 Year 11 Month 20 Day
Anticipated trial start date	2019 Year 11 Month 21 Day
Last follow-up date	2021 Year 10 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	None

Management information
Registered date	2019 Year 11 Month 15 Day
Last modified on	2022 Year 06 Month 13 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000042983