UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038064 |
|---|---|
| Receipt number | R000042823 |
| Scientific Title | EfficAcy and safety of carboPlatin, etoposide and atezOlizumab for the first-line treatment of patients with extensive-stage smaLL cell lung cancer in the real-wOrld setting. |
| Date of disclosure of the study information | 2019/09/24 |
| Last modified on | 2024/09/18 08:27:02 |
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Basic information
Public title
EfficAcy and safety of carboPlatin, etoposide and atezOlizumab for the first-line treatment of patients with extensive-stage smaLL cell lung cancer in the real-wOrld setting.
Acronym
APOLLO study
Scientific Title
EfficAcy and safety of carboPlatin, etoposide and atezOlizumab for the first-line treatment of patients with extensive-stage smaLL cell lung cancer in the real-wOrld setting.
Scientific Title:Acronym
APOLLO study
Region
| Japan |
Condition
Condition
Small cell lung cancer
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To investigate the efficacy and safety of combination carboplatin / etoposide / atezolizumab combination therapy for advanced small cell lung cancer patients in clinical practice in Japan, and the clinical outcome gap between eligible and ineligible patients for chemoimmunotherapy trial
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
6 months-PFS
Key secondary outcomes
Overall survival
Progression free survival
Time to treatment failure
Objective response rate
Safety(severe toxicity)
The difference of clinical outcomes between eligible and ineligible patients for Impower 133 trial
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
| 18 | years-old | <= |
Age-upper limit
| 120 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Extensive-stage small cell lung cancer
Patients scheduled for carboplatin / etoposide / atezolizumab combination therapy
Key exclusion criteria
Patients who are judged by the attending doctor as inappropriate to participate in this clinical research
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Hiroaki |
| Middle name | |
| Last name | Akamatsu |
Organization
Wakayama Medical University
Division name
Third Department of Internal Medicine
Zip code
641-8509
Address
811-1, kimiidera, Wakayama
TEL
073-441-0619
h-akamat@wakayama-med.ac.jp
Public contact
Name of contact person
| 1st name | Daichi |
| Middle name | |
| Last name | Fujimoto |
Organization
Kobe city medical center general hospital
Division name
Division of Respiratory medicine
Zip code
650-0047
Address
2-1-1, minatojima-minamimachi, chuo-ku, Kobe
TEL
078-302-4321
Homepage URL
daichianzen@yahoo.co.jp
Sponsor or person
Institute
Wakayama Medical University
Institute
Department
Personal name
Funding Source
Organization
Chugai Pharmaceutical Co., Ltd.
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
Wakayama medical university
Address
Third Department of Internal Medicine
Tel
073-441-0619
daichianzen@yahoo.co.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
| 2019 | Year | 09 | Month | 24 | Day |
Related information
URL releasing protocol
N/A
Publication of results
Published
Result
URL related to results and publications
https://pubmed.ncbi.nlm.nih.gov/36826813/
Number of participants that the trial has enrolled
208
Results
In conclusion, the efficacy of this therapy in the overall patient population in routine clinical practice was comparable to that observed in previous phase III clinical trials. However, the data suggest that clinical trial results may not necessarily be extrapolated to trial-ineligible patients.
Results date posted
| 2024 | Year | 09 | Month | 18 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
This study aimed to investigate the efficacy and safety of the first-line treatment with carboplatin/etoposide/atezolizumab combination therapy in patients with extensive-stage small cell lung cancer (ES-SCLC) in routine clinical practice in Japan. This was a multicenter, prospective observational study, and a total of 208 patients who received the first-line treatment with carboplatin/etoposide/atezolizumab combination therapy between September 2019 and September 2020 were enrolled and evaluated.
Participant flow
https://pubmed.ncbi.nlm.nih.gov/36826813/
Adverse events
https://pubmed.ncbi.nlm.nih.gov/36826813/
Outcome measures
https://pubmed.ncbi.nlm.nih.gov/36826813/
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2019 | Year | 09 | Month | 20 | Day |
Date of IRB
| 2019 | Year | 09 | Month | 20 | Day |
Anticipated trial start date
| 2019 | Year | 09 | Month | 24 | Day |
Last follow-up date
| 2023 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
prospective cohort study
Management information
Registered date
| 2019 | Year | 09 | Month | 20 | Day |
Last modified on
| 2024 | Year | 09 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042823
