UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036856 |
|---|---|
| Receipt number | R000041170 |
| Scientific Title | Phase II study of immunotherapy and cytotoxic agent in combination with palliative radiotherapy in patients with advanced non-small cell lung cancer |
| Date of disclosure of the study information | 2019/07/05 |
| Last modified on | 2024/06/28 09:49:09 |
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Basic information
Public title
Phase II study of immunotherapy and cytotoxic agent in combination with palliative radiotherapy in patients with advanced non-small cell lung cancer
Acronym
Phase II study of immunotherapy and cytotoxic agent in combination with palliative radiotherapy in patients with advanced non-small cell lung cancer
Scientific Title
Phase II study of immunotherapy and cytotoxic agent in combination with palliative radiotherapy in patients with advanced non-small cell lung cancer
Scientific Title:Acronym
Phase II study of immunotherapy and cytotoxic agent in combination with palliative radiotherapy in patients with advanced non-small cell lung cancer
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 the efficacy of immunotherapy and cytotoxic agent in combination with palliative radiotherapy for untreated patients with advanced non-small cell lung cancer
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
1-year progression-free survival rate
Key secondary outcomes
Response rate, Disease control rate, Progression-free survival, Overall survival, Safety
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine | Device,equipment |
Interventions/Control_1
Palliative radiotherapy (30Gy/10fr)
(a)If lung leasion, V20 equal or less
than 20%
(b)Planning target volume(PTV)volume
equal or more than 50 cm3 and equal
or less than 400 cm3
Start following regimen within 7 days from the start of irradiation.
Non-squamos cell lung cancer
CDDP(day1 75mg/m2) or CBDCA(day1 AUC5)/PEM(day1 500mg/m2)/Pembrolizumab(day1 200mg/body)
every three weeks for up to four cycles
followed by PEM/Pembrolizumab
every three weeks
Squamos cell lung cancer
CBDCA(day1 AUC6)/Paclitacxel(day1 200mg/m2) or nab-paclitacxel(day1,8,15 100mg/m2)/Pembrolizumab(day1 200mg/body)
every three weeks for up to four cycles
followed by Pembrolizumab
every three weeks
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)Cytologically or histologically confirmed non-small cell lung cancer
2)Clinical stage IIIB, IIIC without indication of definitive thoracic radiotherapy, stage IV, or postoperative recurrent disease
3)EGFR mutation status is not active and ALK fusion gene is negative
4)Administrate pembrolizumab and cytotoxic agents for 1st-line therapy
5)Leasions suitable for palliative radiotherapy (30Gy/10fr)
(a)If lung leasion, V20 equal or less than 20%
(b)PTV(planning target volume)volume
equal or more than 50 cm3
equal or less than 400 cm3
6)Aged 20 or older
7)Eastern Cooperative Oncology Group Performance Status (ECOG PS) is 0 or 1
8)At least one measurable lesions except radiation site (RECIST ver1.1)
9)Patients with adequate organ function
10)Patients expected to survive for more than 3 months
11)Have given written consent to participate in the study
Key exclusion criteria
1)Presence of EGFR mutation, ALK fusion gene, ROS1 fusion gene or BRAF mutation
2)Prior immunotherapy or radiotherapy
3)Symptomatic brain metastases
4)Patient with autoimmune disease
5)Patient with history of organ transplantation
6)Severe complication (uncontrolled heart failure, renal failure, chronic liver failure, diabetes mellitus, intestinal obstruction, active gastrointestinal ulceration, etc.)
7)Positive for hepatitis B surface (HBs) antigen or detectable HB virus DNA with positive for HBs antibody or hepatitis B core antibody
8)Radiographically confirmed interstitial pneumonitis
9)Receiving continuous systemic corticosteroid or immunosuppressant treatment or within 2 weeks after discontinuation
10)Pleural effusion, ascites or pericardial effusion requiring drainage
11)Pregnant or lactating females, females of child-bearing potential, and males desiring partner's pregnancy
12)Patient with active double cancer. (Exclude disease free interval over 5 years and carcinoma in situ)
13)History of severe drug allergies
14)Other ineligible status judged by attending doctor
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Eisaku |
| Middle name | |
| Last name | Miyauchi |
Organization
Tohoku University Hospital
Division name
Department of Respiratory Medicine
Zip code
980-8574
Address
1-1 Seiryo-machi, Aoba-ku, Sendai 980-8574, Japan
TEL
022-717-8539
miyauchi@rm.med.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Yoko |
| Middle name | |
| Last name | Tsukita |
Organization
Tohoku University Hospital
Division name
Department of Respiratory Medicine
Zip code
980-8574
Address
1-1 Seiryo-machi, Aoba-ku, Sendai 980-8574, Japan
TEL
022-717-8539
Homepage URL
y-tsukita@rm.med.tohoku.ac.jp
Sponsor or person
Institute
Tohoku University Hospital
Institute
Department
Personal name
Funding Source
Organization
Tohoku University Hospital
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
Tohoku University Hospital Research Ethics Committee
Address
1-1 Seiryo-machi, Aoba-ku, Sendai 980-8574, Japan
Tel
022-728-4105
ec@rinri.hosp.tohoku.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 | 07 | 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
40
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
Completed
Date of protocol fixation
| 2019 | Year | 05 | Month | 01 | Day |
Date of IRB
| 2019 | Year | 07 | Month | 11 | Day |
Anticipated trial start date
| 2019 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 05 | Month | 26 | Day |
Last modified on
| 2024 | Year | 06 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041170
