UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000049022 |
|---|---|
| Receipt number | R000053724 |
| Scientific Title | Efficacy and safety of Immune check point inhibitors in patients with non-small cell lung cancer harboring rare driver oncogene |
| Date of disclosure of the study information | 2022/09/26 |
| Last modified on | 2023/07/04 11:11:56 |
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Basic information
Public title
A real-world study of efficacy and safety of Immune check point inhibitors in patients with non-small cell lung cancer harboring driver oncogene excepting EGFR
Acronym
Efficacy and safety of Immune check point inhibitors in patients with non-small cell lung cancer harboring rare driver oncogene
Scientific Title
Efficacy and safety of Immune check point inhibitors in patients with non-small cell lung cancer harboring rare driver oncogene
Scientific Title:Acronym
Efficacy and safety of Immune check point inhibitors in patients with non-small cell lung cancer harboring rare driver oncogene
Region
| Japan |
Condition
Condition
Non-small cell lung cancer harboring driver oncogene excepting EGFR
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
We will retrospectively evaluate the efficacy and safety of immune checkpoint inhibitor (ICI) therapy in patients with unresectable or postoperatively recurrent non-small cell lung cancer harboring rare driver oncogene mutation/translocation. Secondary, the efficacy and safety of molecular targeted therapy in actual clinical practice will also be retrospectively evaluated.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Progression-free survival of immune checkpoint inhibitor therapy with or without chemotherapy
Key secondary outcomes
Response rate of immune checkpoint inhibitor therapy with or without chemotherapy, Immune-related adverse events, Response rate of molecular targeted therapy, Progression-free survival of molecular targeted therapy, Time to treatment failure of molecular targeted therapy, Overall survival from start date of the first line treatment, Cluster analysis of survival
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) Patients with histologically or cytologically confirmed non-small cell lung cancer at clinical stage IIIA, IIIB, IIIC, IVA, IVB or postoperative recurrence that is not amenable to local treatment.
(2) ALK, ROS1, MET, BRAF, KRAS, HER2, RET, NTRK are proven.
(3) Patients who have received systemic chemotherapy between January 2015 and December 2021.
Key exclusion criteria
(1) Patients who are judged by the principal investigator or sub-investigator to be inappropriate for participation in this study.
(2) Patients who had no driver mutation/translocation or EGFR mutation only.
Target sample size
870
Research contact person
Name of lead principal investigator
| 1st name | Takehito |
| Middle name | |
| Last name | Shukuya |
Organization
Juntendo University School of Medicine
Division name
Respiratory Medicine
Zip code
113-8431
Address
Hongo 3-1-3, Bunkyo-ku, Tokyo
TEL
0338133111
tshukuya@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | Atsuto |
| Middle name | |
| Last name | Mouri |
Organization
Saitama Medical University International Medical Center
Division name
Respiratory medicine
Zip code
350-1298
Address
350-1298 Yamane 1397-1, Hidaka-city, Saitama
TEL
09016016701
Homepage URL
mouria@saitama-med.ac.jp
Sponsor or person
Institute
North East Japan Study Group
Institute
Department
Personal name
Funding Source
Organization
Novartis Pharma KK
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
Saitama Medical University International Medical Center
Address
350-1298 Yamane 1397-1, Hidaka city, Saitama
Tel
0429844111
chikens@saitama-med.ac.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
2022-007
Org. issuing International ID_1
Saitama Medical University International Medical Center
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
埼玉医科大学国際医療センター
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 09 | 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
Open public recruiting
Date of protocol fixation
| 2022 | Year | 05 | Month | 30 | Day |
Date of IRB
| 2022 | Year | 06 | Month | 20 | Day |
Anticipated trial start date
| 2022 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2023 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Retrospective study
Management information
Registered date
| 2022 | Year | 09 | Month | 26 | Day |
Last modified on
| 2023 | Year | 07 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000053724
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