UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030699 |
|---|---|
| Receipt number | 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 | 2020/01/07 14:46:38 |
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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 | Naoki |
| Middle name | |
| Last name | Katsuhiko |
Organization
Kitasato University School of Medicine
Division name
Department of Respiratory Medicine
Zip code
252-0374
Address
1-15-1 Kitasato, Minami-ku, Sagamihara, Kanagawa
TEL
042-778-8111
naoki@med.kitasato-u.ac.jp
Public contact
Name of contact person
| 1st name | Tomoya |
| Middle name | |
| Last name | Fukui |
Organization
Kitasato University School of Medicine
Division name
Department of Respiratory Medicine
Zip code
252-0374
Address
1-15-1 Kitasato, Minami-ku, Sagamihara, Kanagawa
TEL
042-778-8111
Homepage URL
tofukui@med.kitasato-u.ac.jp
Sponsor or person
Institute
Kitasato University
Institute
Department
Personal name
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
the Kitasato University Medical Ethics Organization
Address
1-15-1 Kitasato, Minami-ku, Sagamihara, Kanagawa
Tel
042-778-7756
rinri@med.kitasato-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
| 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
1
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
| 2018 | Year | 01 | Month | 05 | Day |
Date of IRB
| 2018 | Year | 02 | Month | 20 | Day |
Anticipated trial start date
| 2018 | Year | 02 | Month | 20 | Day |
Last follow-up date
| 2019 | Year | 12 | Month | 08 | Day |
Date of closure to data entry
| 2019 | Year | 12 | Month | 08 | Day |
Date trial data considered complete
| 2019 | Year | 12 | Month | 08 | Day |
Date analysis concluded
| 2019 | Year | 12 | Month | 08 | Day |
Other
Other related information
Management information
Registered date
| 2018 | Year | 01 | Month | 05 | Day |
Last modified on
| 2020 | Year | 01 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035047
