UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000049780 |
|---|---|
| Receipt number | R000056697 |
| Scientific Title | Explore research of chemoimmunotherapy and angiogenesis inhibitor for KRAS-mutant non-small cell lung cancer patients; prospective observation study |
| Date of disclosure of the study information | 2023/01/04 |
| Last modified on | 2024/02/25 20:17:46 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Explore research of chemoimmunotherapy and angiogenesis inhibitor for KRAS-mutant non-small cell lung cancer patients; prospective observation study
Acronym
Explore research of chemoimmunotherapy and angiogenesis inhibitor for KRAS-mutant non-small cell lung cancer patients; prospective observation study
Scientific Title
Explore research of chemoimmunotherapy and angiogenesis inhibitor for KRAS-mutant non-small cell lung cancer patients; prospective observation study
Scientific Title:Acronym
Explore research of chemoimmunotherapy and angiogenesis inhibitor for KRAS-mutant non-small cell lung cancer patients; prospective observation study
Region
| Japan |
Condition
Condition
Non-squamous non-small cell lung cancer
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and safety of chemoimmunotherapy and angiogenesis inhibitors in patients with KRAS mutation-positive non-squamous cell non-small cell lung cancer in a practical setting.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Progression free survival: PFS
Key secondary outcomes
Time to treatment failure: TTF
Overall survival: OS
Overall response rate; ORR
Disease control rate; DCR
Adverse events including immune related adverse events.
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
(1) Non-squamous cell non-small cell lung cancer confirmed by histology or cytology.
(2) Clinical stage IIIB, IIIC, IVA, IVB* or postoperative recurrence for which surgery or curative radiation is not possible.
*Lung Cancer Treatment Regulations (April 2021 [8th Edition, Revised]) Japan Lung Cancer Society/Ed.
(2) Cases of recurrence after adjuvant therapy for the treatment of non-small cell lung cancer could be enrolled as long as it is the first treatment after the completion of adjuvant chemotherapy.
(3) Patients must be at least 20 years of age at the time of consent.
(4) Patients with KRAS active gene mutation (G12C, G12D/S, G12A/V/R, or G13C).
(5) Patients who are scheduled to receive combination therapy with chemotherapy, angiogenesis inhibitors, or immune checkpoint inhibitors, including platinum-based agents, in accordance with the latest package insert and the latest guidelines for promoting optimal use of each drug.
(6) Written consent has been obtained from the patients after a thorough explanation of the study details has been provided prior to enrollment in this clinical study.
Key exclusion criteria
(1) Patients deemed inappropriate by the physician in charge.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Tadaaki |
| Middle name | |
| Last name | Yamada |
Organization
University Hospital, Kyoto Prefectural University of Medicine
Division name
Department of pulmonary medicine
Zip code
602-8566
Address
465, Kajii-cho, Kamigyo-ku, Kyoto
TEL
075-251-5513
tayamada@koto.kpu-m.ac.jp
Public contact
Name of contact person
| 1st name | Masaki |
| Middle name | |
| Last name | Ishida |
Organization
University Hospital, Kyoto Prefectural University of Medicine
Division name
Department of pulmonary medicine
Zip code
602-8566
Address
465, Kajii-cho, Kamigyo-ku, Kyoto, Japan
TEL
075-251-5513
Homepage URL
mishida@koto.kpu-m.ac.jp
Sponsor or person
Institute
Kyoto Prefectural University of Medicine
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Review Board of Kyoto Prefectural University of Medicine
Address
465, Kajii-cho, Kamigyo-ku, Kyoto, Japan
Tel
602-8566
rinri@koto.kpu-m.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
| 2023 | Year | 01 | Month | 04 | 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
Open public recruiting
Date of protocol fixation
| 2022 | Year | 10 | Month | 20 | Day |
Date of IRB
| 2022 | Year | 11 | Month | 09 | Day |
Anticipated trial start date
| 2022 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
A multicenter prospective observational study
Eligibility criteria include patients who are to receive immunochemotherapy and angiogenesis inhibitor in a practical setting in each participating institution and those who provide written informed consent.
Management information
Registered date
| 2022 | Year | 12 | Month | 14 | Day |
Last modified on
| 2024 | Year | 02 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000056697
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
