UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032376 |
|---|---|
| Receipt number | R000036623 |
| Scientific Title | A Feasibility Study of Carboplatin/Paclitaxel/Nivolumab with Concurrent Thoracic Radiotherapy in Patients with Unresectable Locally Advanced Non-Small-Cell Lung Cancer |
| Date of disclosure of the study information | 2018/04/26 |
| Last modified on | 2024/07/12 09:14:46 |
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Basic information
Public title
A Feasibility Study of Carboplatin/Paclitaxel/Nivolumab with Concurrent Thoracic Radiotherapy in Patients with Unresectable Locally Advanced Non-Small-Cell Lung Cancer
Acronym
A Feasibility Study of Carboplatin/Paclitaxel/Nivolumab with Concurrent Thoracic Radiotherapy in Patients with Unresectable Locally Advanced Non-Small-Cell Lung Cancer
Scientific Title
A Feasibility Study of Carboplatin/Paclitaxel/Nivolumab with Concurrent Thoracic Radiotherapy in Patients with Unresectable Locally Advanced Non-Small-Cell Lung Cancer
Scientific Title:Acronym
A Feasibility Study of Carboplatin/Paclitaxel/Nivolumab with Concurrent Thoracic Radiotherapy in Patients with Unresectable Locally Advanced Non-Small-Cell Lung Cancer
Region
| Japan |
Condition
Condition
Unresectable locally advanced non-small-cell lung cancer
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To assess safety of the combination therapy, carboplatin/paclitaxel/nivolumab, with concurrent thoracic radiotherapy for unresectable locally advanced non-small-cell lung cancer
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Dose limiting toxicity (DLT): for 90 days from start of therapy
Key secondary outcomes
1) Safety: adverse events
2) Efficacy: response rate, progression free survival, overall survival, 2-year survival rate
3) Completion rate of therapy (concurrent phase)
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 | Maneuver |
Interventions/Control_1
Concurrent phase
carboplatin, paclitaxel, nivolumab, thoracic radiotherapy
Chemoeherapy (consolidation) <optional>
carboplatin, paclitaxel, nivolumab
Maintenance therapy
nivolumab
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
| 74 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Cytologically or Histologically confirmed unresectable locally advanced non-small-cell lung cancer
2) Clinical stage III, possible radical irradiation
3) Untreated by systemic anticancer therapy or thoracic radiotherapy
4) ECOG PS 0-1
Key exclusion criteria
1) Double cancer
2) Interstitial pneumonia or pulmonary fibrosis
3) Diverticulitis or peptic ulcer
4) Severe lung disease, for example, emphysema, chronic bronchitis and bronchial asthma
5) Drug-induced interstitial pneumonia or severe drug allergy
6) Active tuberculosis or treatment history of tuberculosis
7) History of anaphylaxis induced by other antibody preparation
8) Uncontrollable diabetes
9) Active autoimmune disease
10) Peripheral neuropathy (>Grade 2)
11) Patients who received transplantation therapy
12) Patients who are receiving continuous systemic administration of steroids or immunosuppressants
13) The patient received or is scheduled to receive a live or attenuated vaccine within 28 days before the first dose of the investigational product
14) History of treatment for T cell regulation
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Takayasu |
| Middle name | |
| Last name | Kurata |
Organization
Kansai Medical University Hospital
Division name
Department of Thoracic Oncology
Zip code
5731191
Address
2-3-1, Shinmachi, Hirakata, Osaka, 573-1191 Japan
TEL
072-804-0101
kuratat@hirakata.kmu.ac.jp
Public contact
Name of contact person
| 1st name | Tatsushi |
| Middle name | |
| Last name | Goto |
Organization
Secretariat of clinical trial coordinating committee
Division name
none
Zip code
5300044
Address
Urban Ace Higashitenma-BLDG, 1-1-19, Higashitenma, Kita-ku, Osaka, 530-0044 Japan
TEL
06-6358-7110
Homepage URL
gotou@fiverings.co.jp
Sponsor or person
Institute
Department of Thoracic Oncology, Kansai Medical University Hospiital
Institute
Department
Personal name
Funding Source
Organization
Ono pharmaceutical Co, Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
-
Address
2-3-1, Shinmachi, Hirakata City, Osaka, 573-1191, Japan
Tel
-
-
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
関西医科大学附属病院（大阪府）、医療法人徳洲会和泉市立総合医療センター（大阪府）
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 04 | Month | 26 | 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
Completed
Date of protocol fixation
| 2018 | Year | 02 | Month | 21 | Day |
Date of IRB
| 2018 | Year | 04 | Month | 16 | Day |
Anticipated trial start date
| 2018 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 02 | Month | 28 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 04 | Month | 25 | Day |
Last modified on
| 2024 | Year | 07 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036623
