UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044807 |
|---|---|
| Receipt number | R000050181 |
| Scientific Title | Prospective observation study for combination therapy of Docetaxel and Ramucirumab after immunochemotherapy in advanced non-small cell lung cancer patients |
| Date of disclosure of the study information | 2021/07/09 |
| Last modified on | 2024/07/11 13:37:09 |
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Basic information
Public title
Prospective observation study for combination therapy of Docetaxel and Ramucirumab after immunochemotherapy in advanced non-small cell lung cancer patients
Acronym
Prospective observation study for combination therapy of Docetaxel and Ramucirumab after immunochemotherapy in advanced non-small cell lung cancer patients
Scientific Title
Prospective observation study for combination therapy of Docetaxel and Ramucirumab after immunochemotherapy in advanced non-small cell lung cancer patients
Scientific Title:Acronym
Prospective observation study for combination therapy of Docetaxel and Ramucirumab after immunochemotherapy in advanced non-small cell lung cancer patients
Region
| Japan |
Condition
Condition
Non small cell lung cac
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Exploring the determinants of sensitivity to docetaxel plus ramucirumab in non-small cell lung cancer after combined immunotherapy
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
progression free survival
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
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Patients aged 20 years or older with PS 0-2 at the time of obtaining 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 with a history of treatment with immune checkpoint inhibitors and chemotherapy (discontinuation due to adverse events is acceptable)
(5) Patients whose tumor PD-L1 expression is being measured using anti-22C3 antibody
(6) Patients who have been fully informed about the contents of this clinical study and have given their free written consent.
(6) Patients who have been fully informed about the contents of this clinical study and have given their free written consent.
Key exclusion criteria
1) Patients with a history of treatment with systemic chemotherapy after combination therapy with immune checkpoint inhibitors and chemotherapy
2) Patients with active multiple cancers (hormone therapy for prostate cancer and breast cancer is acceptable)
(3)Other patients who are deemed inappropriate by the physician in charge
Target sample size
50
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
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
Kyoto Prefectural University of Medicine
Address
465, Kajii-cho, Kamigyo-ku, Kyoto
Tel
0752515337
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 | 07 | Month | 09 | Day |
Related information
URL releasing protocol
https://academic.oup.com/oncolo/article/29/5/e681/7577447?login=true
Publication of results
Published
Result
URL related to results and publications
https://academic.oup.com/oncolo/article/29/5/e681/7577447?login=true
Number of participants that the trial has enrolled
44
Results
Overall, 44 patients were enrolled from 10 Japanese institutions between April 2020 and June 2022. The median PFS and OS were 6.3 and 22.6 months, respectively. Furthermore, the ORR and DCR were 36.4% and 72.7%, respectively. The high vascular endothelial growth factor D (VEGF-D) group had a significantly shorter PFS and OS. A combination of high VEGF-A and low VEGF-D levels was associated with a longer PFS.
Results date posted
| 2024 | Year | 07 | Month | 11 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
The inclusion criteria were as follows: (i) histologically and cytologically confirmed unresectable advanced or recurrent NSCLC and (ii) previously treated with combined chemoimmunotherapy. Patients with systemic chemotherapy or immunotherapy history after combination chemoimmunotherapy were excluded.
Participant flow
Forty-four patients were enrolled from 8 institutions in Japan from April 2020 to June 2022 in this study.
Adverse events
All AE grades and grades 3, 4 were observed in 38 (88.4%) and 18 (41.9%) patients, respectively. Grades 3,4 neutropenia and febrile neutropenia were observed in 8 (18.6%) and 2 (4.7%) patients, respectively. All grades and grades 3, 4 pneumonitis were observed in 4 (9.3%) and 3 (7.0%) patients, respectively. No grade 5 AE was observed
Outcome measures
The primary endpoint was progression-free survival (PFS). Secondary endpoints were the objective response rate (ORR), disease control rate (DCR), overall survival (OS), and incidence of adverse events.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2020 | Year | 01 | Month | 05 | Day |
Date of IRB
| 2020 | Year | 03 | Month | 03 | Day |
Anticipated trial start date
| 2020 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 12 | Month | 31 | 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 | 07 | Month | 09 | Day |
Last modified on
| 2024 | Year | 07 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050181
