UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037967 |
|---|---|
| Receipt number | R000043275 |
| Scientific Title | A multicenter prospective observational study of atezolizumab plus bevacizumab plus carboplatin plus paclitaxel (ABCP) in patients with unresectable advanced or relapsed EGFR-mutation positive nonsquamous non-small-cell lung cancer: ABCP observational study |
| Date of disclosure of the study information | 2019/09/10 |
| Last modified on | 2023/03/12 09:57:10 |
* 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
A multicenter prospective observational study of atezolizumab plus bevacizumab plus carboplatin plus paclitaxel (ABCP) in patients with unresectable advanced or relapsed EGFR-mutation positive nonsquamous non-small-cell lung cancer: ABCP observational study
Acronym
ABCP observational study
Scientific Title
A multicenter prospective observational study of atezolizumab plus bevacizumab plus carboplatin plus paclitaxel (ABCP) in patients with unresectable advanced or relapsed EGFR-mutation positive nonsquamous non-small-cell lung cancer: ABCP observational study
Scientific Title:Acronym
ABCP multicenter prospective observational study
Region
| Japan |
Condition
Condition
non-small-cell lung cancer
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To assess the long-term effectiveness and safety of ABCP therapy in practical setting
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Progression Free Survival: PFS
Key secondary outcomes
Overall survival: OS
Time to treatment failure: TTF
Overall response rate: ORR
Adverse events
Patient reported outcomes: PRO (Assessment of chemotherapy-induced peripheral neuropathy)
And others
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, A patient aged 20 or older at the time of informed consent.
2, A patient with unresectable advanced or relapsed EGFR-mutation positive nonsquamous non-small-cell lung cancer.(Eligible regardless of EGFR-mutation subtypes)
3, A patient who has been treated with prior EGFR-TKI therapies.(Eligible if a patient received a prior osimertinib therapy after 1st or 2nd generation EGFR-TKI therapies)
4, A patient who is to receive ABCP therapy in a practical setting based on package inserts and guidelines for optimal use.
5, A patient who provides written informed consent.
Key exclusion criteria
A Patient who is judged ineligible to enroll the study by an attending doctor.
Target sample size
140
Research contact person
Name of lead principal investigator
| 1st name | Takayasu |
| Middle name | |
| Last name | Kurata |
Organization
Kansai Medical University Hospital
Division name
Department of Thoracic Oncology
Zip code
573-1191
Address
2-3-1 Shinmachi, Hirakata, Japan
TEL
072-804-0101
kuratat@hirakata.kmu.ac.jp
Public contact
Name of contact person
| 1st name | Hiroshige |
| Middle name | |
| Last name | Yoshioka |
Organization
Kansai Medical University Hospital
Division name
Department of Thoracic Oncology
Zip code
573-1191
Address
2-3-1 Shinmachi, Hirakata, Japan
TEL
072-804-0101
Homepage URL
hgyoshioka@gmail.com
Sponsor or person
Institute
Department of Thoracic Oncology, Kansai Medical University Hospital
Institute
Department
Personal name
Funding Source
Organization
Chugai Pharmaceutical Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Center for Ethical Review, Kansai Medical University
Address
2-5-1 Shinmachi, Hirakata, Japan
Tel
072-804-0101
rinriirb@hirakata.kmu.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
大阪医科大学附属病院（大阪府）、大阪市立大学医学部附属病院（大阪府）、大阪国際がんセンター（大阪府）、関西医科大学附属病院（大阪府）、近畿中央呼吸器病センター（大阪府）、倉敷中央病院（岡山県）、神戸市立医療センター中央市民病院（兵庫県）、神戸大学医学部附属病院（兵庫県）、神戸低侵襲がん医療センター（兵庫県）、名古屋医療センター（愛知県）、新潟県立がんセンター新潟病院（新潟県）、兵庫県立尼崎医療センター（兵庫県）、松阪市民病院（三重県）、和歌山県立医科大学（和歌山県）など
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 09 | Month | 10 | 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
142
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
Main results already published
Date of protocol fixation
| 2019 | Year | 08 | Month | 28 | Day |
Date of IRB
| 2019 | Year | 08 | Month | 28 | Day |
Anticipated trial start date
| 2019 | Year | 09 | Month | 10 | Day |
Last follow-up date
| 2023 | Year | 02 | Month | 28 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2024 | Year | 02 | Month | 28 | Day |
Other
Other related information
A multicenter prospective observational study
Eligibility criteria include patients who are to receive ABCP therapy in practical setting in each participating institution and those who provide written informed consent.
Management information
Registered date
| 2019 | Year | 09 | Month | 08 | Day |
Last modified on
| 2023 | Year | 03 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043275
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
| 2022/05/16 | ABCP_UMIN固定用シート別ファイル(識別番号なし)_20220513_ABCP.xlsx |
