UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052124 |
|---|---|
| Receipt number | R000059137 |
| Scientific Title | Cost-effectiveness analysis of systemic therapy for non-small cell lung cancer based on real-world data |
| Date of disclosure of the study information | 2023/09/05 |
| Last modified on | 2024/04/09 19:29:57 |
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Basic information
Public title
Cost-effectiveness analysis of systemic therapy for non-small cell lung cancer based on real-world data
Acronym
Cost-effectiveness analysis of systemic therapy for non-small cell lung cancer based on real-world data
Scientific Title
Cost-effectiveness analysis of systemic therapy for non-small cell lung cancer based on real-world data
Scientific Title:Acronym
Cost-effectiveness analysis of systemic therapy for non-small cell lung cancer based on real-world data
Region
| Japan |
Condition
Condition
non-small cell lung cancer
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
In this research, our primary focus lies on cancer patients undergoing treatment with costly, unremovable, and advanced recurrent non-small cell lung cancer therapeutics. The objective is to perform a cost-effectiveness analysis, rooted in real-world data pertaining to survival duration, expenditures, and health-related quality of life metrics. Through this rigorous investigation, we endeavor to unveil the genuine cost-effectiveness of anti-cancer medications.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
From the initiation of anticancer drug treatment following fulfillment of inclusion criteria until the date of death, the incremental cost-effectiveness ratios (ICERs) for the four groups, namely B to E, relative to the base case A, are as follows:
A. Cytotoxic anticancer agent
B. Platinum combination therapy + PD-1/PD-L1 inhibitor
C. Platinum combination therapy + PD-1 inhibitor + CTLA-4 inhibitor
D. PD-1 inhibitor + CTLA-4 inhibitor
E. PD-1/PD-L1 inhibitor
We will evaluate and compare the ICERAB, ICERAC, ICERAD, and ICERAE to assess the cost-effectiveness of these different therapeutic approaches for the specified patient population.
Key secondary outcomes
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
The study will include patients who meet the following criteria:
Patients diagnosed with unresectable, advanced recurrent non-small cell lung cancer.
Patients receiving anticancer drug treatment for unresectable, advanced recurrent non-small cell lung cancer.
Patients with ECOG Performance Status (PS) of 0 or 1.
Patients aged 20 years or older at the time of obtaining consent.
Patients who have provided consent to participate in this trial.
The definition of unresectable, advanced recurrent cancer is as follows:
Stage III with inoperable lesions due to the impossibility of curative radiotherapy.
Stage IV.
Postoperative recurrence.
Recurrence after radiation monotherapy.
Key exclusion criteria
Patients with the following driver gene mutations or translocations will be included:
EGFR gene mutation
ALK fusion gene
ROS1 fusion gene
BRAF gene mutation
MET gene mutation
RET fusion gene
NTRK fusion gene
In the future, if new primary standard treatments are identified for additional driver gene mutations or translocations, patients with those newly identified driver gene mutations or translocations will also be excluded from the study.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Takenori |
| Middle name | |
| Last name | Ichimura |
Organization
Showa University School of Pharmacy
Division name
Department of Hospital Pharmaceutics
Zip code
142-8555
Address
1-5-8, Shinagawa-ku, Tokyo, 142-8555, Japan
TEL
03-3784-8000
ichimura@cmed.showa-u.ac.jp
Public contact
Name of contact person
| 1st name | Takenori |
| Middle name | |
| Last name | Ichimura |
Organization
Showa University School of Pharmacy
Division name
Department of Hospital Pharmaceutics
Zip code
142-8555
Address
1-5-8, Shinagawa-ku, Tokyo, 142-8555, Japan
TEL
03-3784-8000
Homepage URL
ichimura@cmed.showa-u.ac.jp
Sponsor or person
Institute
Showa University
Institute
Department
Personal name
Takenori Ichimura
Funding Source
Organization
Ministry of Education, Culture, Sports, Science, and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Showa University Research Ethics Review Board
Address
1-5-8, Shinagawa-ku, Tokyo, 142-8555, Japan
Tel
03-3784-8129
m-rinri@ofc.showa-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
昭和大学横浜市北部病院
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 09 | 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
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
Enrolling by invitation
Date of protocol fixation
| 2023 | Year | 08 | Month | 24 | Day |
Date of IRB
| 2023 | Year | 08 | Month | 24 | Day |
Anticipated trial start date
| 2023 | Year | 09 | Month | 19 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Before the start of the examination
Management information
Registered date
| 2023 | Year | 09 | Month | 05 | Day |
Last modified on
| 2024 | Year | 04 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059137
