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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000030699
Receipt No. R000035047
Scientific Title A confirmatory study of activity of immune checkpoint inhibitors for non-small cell lung cancer patients with interstitial pneumonia
Date of disclosure of the study information 2018/03/01
Last modified on 2018/01/05

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Basic information
Public title A confirmatory study of activity of immune checkpoint inhibitors for non-small cell lung cancer patients with interstitial pneumonia
Acronym ICI Activity for NSCLC with IP
Scientific Title A confirmatory study of activity of immune checkpoint inhibitors for non-small cell lung cancer patients with interstitial pneumonia
Scientific Title:Acronym ICI Activity for NSCLC with IP
Region
Japan

Condition
Condition Non-small cell lung cancer patients with interstitial pneumonia
Classification by specialty
Pneumology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Safety and efficacy of immune checkpoint inhibitors for standard chemotherapy-resistant non-small cell lung cancer patients with interstitial pneumoniae were evaluated.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Exacerbation rate of interstitial lung diseases up to 6 months after initiation of immune checkpoint inhibitors
Key secondary outcomes Overall response rate, Progression free survival, Overall survival, Adverse events, Risk factors developing exacerbation of interstial lung disease

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 Immune checkpoint inhibitors
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) Standard chemotherapy-resistant and relapsed non-small cell lung cancer patients
2) Patients with interstitial lung disease3) Age 20 years and over
4) ECOG performance status (PS) 0-2
5) No palliative radiotherapy for metastatic lesion within 14 days (local irradiation to brain metastatic lesion within 7 days) before registration
6) No grade 3 or higher superior vena cava syndrome, pericardial effusion, pleural effusion or ascites
7) With or without measurable lesions
8) Laboratory test at the start of treatment satisfies the following criteria:
1. WBC >= 3,000 /mm3
2. Neutrophil >= 1,000 /mm3
3. Hb >= 8.0 g/dL
4. Plt >= 7.5 x 10,000 /mm3
5. AST <= 100 IU/L
6. ALT <= 100 IU/L
7. T-Bil <= 1.5 mg/dL
8. Cr <= 1.2 mg/dL
9. SpO2 >= 90 % (room air)
9) Document consent has been obtained from the patient
Key exclusion criteria 1) Systemic administration of steroids at 10 mg/day or more in terms of predonin
2) Active infection requiring systemic treatment
3) Fever of 38 degrees or more at axillary temperature at registration
4) Mental illness or psychiatric symptoms
5) Symptomatic brain metastases
6) Poor control hypertension
7) Continuous systemic administration of immunosuppressants
8) Poor control diabetes
9) Hypersensitivity to the drug
10) Pregnant women, lactating women, women who may be pregnant, or they are not willing to contraceptive
11) In addition, cases judged inappropriate by the attending physician
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Katsuhiko Naoki
Organization Kitasato University School of Medicine
Division name Department of Respiratory Medicine
Zip code
Address 1-15-1 Kitasato, Minami-ku, Sagamihara, Kanagawa
TEL 042-778-8111
Email naoki@med.kitasato-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tomoya Fukui
Organization Kitasato University School of Medicine
Division name Department of Respiratory Medicine
Zip code
Address 1-15-1 Kitasato, Minami-ku, Sagamihara, Kanagawa
TEL 042-778-8111
Homepage URL
Email tofukui@med.kitasato-u.ac.jp

Sponsor
Institute Kitasato University
Institute
Department

Funding Source
Organization Kitasato University
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
Address
Tel
Email

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 03 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
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
2018 Year 01 Month 05 Day
Date of IRB
Anticipated trial start date
2018 Year 02 Month 20 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 01 Month 05 Day
Last modified on
2018 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=R000035047

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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