UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043958 |
|---|---|
| Receipt number | R000050175 |
| Scientific Title | Exploratory research of immunochemotherapy for advanced non-small cell lung cancer patients; prospective observation study |
| Date of disclosure of the study information | 2021/04/19 |
| Last modified on | 2022/10/18 21:15:35 |
* 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
Exploratory research of immunochemotherapy for advanced non-small cell lung cancer patients; prospective observation study
Acronym
Prospective resaerch of immunochemotherapy for advanced NSCLC patients
Scientific Title
Exploratory research of immunochemotherapy for advanced non-small cell lung cancer patients; prospective observation study
Scientific Title:Acronym
Prospective resaerch of immunochemotherapy for advanced NSCLC patients
Region
| Japan |
Condition
Condition
Non small cell lung cancer
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate the efficacy and safety of combination therapy with immune checkpoint inhibitors and chemotherapy in advanced stage or postoperative recurrent non-small cell lung cancer
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Progression-free survival
Key secondary outcomes
Overall survival, response rate, disease control rate, time to treatment failure, and incidence and grade of adverse events including immune-related adverse events
Association of PD-L1 expression in tumors with response to combined chemoimmunotherapy
Association between treatment response and patient background for combined chemoimmunotherapy
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) Patients aged 20 years or older with PS0-2 at the time of consent
(2) Patients with advanced or recurrent non-small cell lung cancer that is not curatively resectable
(3) Patients with evaluable lesions by RECIST (version 1.1)
(4) Patients who are scheduled to receive combination therapy with immune checkpoint inhibitors and chemotherapy
(5) Patients whose tumor PD-L1 protein expression has been examined using formalin-fixed paraffin-embedded blocks in areas that do not interfere with pathological diagnosis, and whose consent has been obtained from the patient.
(6) Patients who have been fully informed about the contents of this clinical study and have given free written consent from the research subject.
Key exclusion criteria
(1)Patients with a history of treatment with systemic chemotherapy or immune checkpoint inhibitors (However, molecularly targeted cancer drugs for patients with driver gene mutation positive, and postoperative adjuvant chemotherapy for patients with postoperative recurrence are acceptable)
(2)Other patients who are deemed inappropriate by the physician in charge.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Tadaaki |
| Middle name | |
| Last name | Yamada |
Organization
Kyoto Prefectural University of Medicine
Division name
Pulmonary Medicine
Zip code
602-8566
Address
465, Kajii-cho, Kamigyo-ku, Kyoto
TEL
0752515513
tayamada@koto.kpu-m.ac.jp
Public contact
Name of contact person
| 1st name | Yuki |
| Middle name | |
| Last name | Katayama |
Organization
Kyoto Prefectural University of Medicine
Division name
Pulmonary Medicine
Zip code
602-8566
Address
465, Kajii-cho, Kamigyo-ku, Kyoto
TEL
0752515513
Homepage URL
ktym2487@koto.kpu-m.ac.jp
Sponsor or person
Institute
Kyoto Prefectural University of Medicine
Institute
Department
Personal name
Funding Source
Organization
Kyoto Prefectural University of Medicine
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
Kyoto Prefectural University of Medicine
Address
465, Kajii-cho, Kamigyo-ku, Kyoto
Tel
0752515513
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
| 2021 | Year | 04 | Month | 19 | 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
100
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
No longer recruiting
Date of protocol fixation
| 2019 | Year | 09 | Month | 05 | Day |
Date of IRB
| 2019 | Year | 09 | Month | 30 | Day |
Anticipated trial start date
| 2019 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2021 | Year | 04 | Month | 17 | Day |
Last modified on
| 2022 | Year | 10 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050175
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
