UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000051395 |
|---|---|
| Receipt number | R000058632 |
| Scientific Title | A retrospective observational study to examine the clinical background and course of treatment-effective cases of immune checkpoint inhibitor with or without cytotoxic anticancer therapy as initial chemotherapy in advanced non-small cell lung cancer |
| Date of disclosure of the study information | 2023/08/01 |
| Last modified on | 2023/09/21 19:21:38 |
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Basic information
Public title
A retrospective observational study to examine the clinical background and course of treatment-effective cases of immune checkpoint inhibitor with or without cytotoxic anticancer therapy as initial chemotherapy in advanced non-small cell lung cancer
Acronym
OLCSG2302
Scientific Title
A retrospective observational study to examine the clinical background and course of treatment-effective cases of immune checkpoint inhibitor with or without cytotoxic anticancer therapy as initial chemotherapy in advanced non-small cell lung cancer
Scientific Title:Acronym
OLCSG2302
Region
| Japan |
Condition
Condition
advanced non-small cell lung cancer
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to clarify treatment efficacy, exacerbation patterns, frequency of immune-related adverse events, post treatment details, and their relationship to prognosis in patients who have benefited from initial immune checkpoint inhibitor with or without cytotoxic chemotherapy, to examine the clinical background and course of these patients, and to consider better treatment strategies.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Efficacy and safety of initial immune checkpoint inhibitor with or without cytotoxic chemotherapy
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(1) Histologically or cytologically (excluding sputum cytology) confirmed to be NSCLC. (Mixed types are excluded if they contain small cell carcinoma.)
(ii) Patients have clinical stage III or IV (according to UICC-TNM 8th edition) or postoperative recurrent NSCLC for which radical resection or radical radiotherapy is not possible without systemic chemotherapy.
(iii) ICI with or without chemo as indicated below is initiated as initial systemic chemotherapy from January 2019 to October 2021. However, if systemic chemotherapy (excluding cases treated with ICI) is given as postoperative chemotherapy, the patient is eligible if more than 6 months have elapsed since the last administration of that chemotherapy.
(iv) The patient has been confirmed to be non-PD for at least 3 months after the start of ICI+chemo treatment.
Key exclusion criteria
(1) Patients have multiple cancers with a disease-free interval of less than 1 year at the time of ICI with or without chemo treatment. (Disease-free intervals are acceptable if the epithelial and intramucosal cancer lesions are judged to be curable by local treatment.
(2) History of ICI treatment prior to initiation of ICI with or without chemo treatment.
(iii) Recurrence after radical thoracic radiotherapy.
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Daijiro |
| Middle name | |
| Last name | Harada |
Organization
National Hospital Organization Shikoku Cancer Center
Division name
Department of Thoracic Oncology and Medicine
Zip code
791-0280
Address
160 Kou Minamiumemoto-machi, Matsuyama-shi, Ehime
TEL
+81-89-9991111
harada.daijiro.kn@mail.hosp.go.jp
Public contact
Name of contact person
| 1st name | Dajiro |
| Middle name | |
| Last name | Harada |
Organization
National Hospital Organization Shikoku Cancer Center
Division name
Department of Thoracic Oncology and Medicine
Zip code
791-0280
Address
791-0280
TEL
+81-89-9991111
Homepage URL
harada.daijiro.kn@mail.hosp.go.jp
Sponsor or person
Institute
National Hospital Organization Shikoku Cancer Center
Institute
Department
Personal name
Funding Source
Organization
National Hospital Organization Shikoku Cancer Center
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
National Hospital Organization Shikoku Cancer Center
Address
160 Kou Minamiumemoto-machi, Matsuyama-shi, Ehime
Tel
+81-89-9991111
harada.daijiro.kn@mail.hosp.go.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 | 08 | Month | 01 | 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 | 04 | Month | 11 | Day |
Date of IRB
| 2023 | Year | 07 | Month | 28 | Day |
Anticipated trial start date
| 2023 | Year | 08 | 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
retrospective observational study, medical record survey, no invasion or intervention
Management information
Registered date
| 2023 | Year | 06 | Month | 20 | Day |
Last modified on
| 2023 | Year | 09 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000058632
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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