UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038683 |
|---|---|
| Receipt number | R000044061 |
| Scientific Title | Real-world observational study on the efficacy and safety of first-line osimertinib treatment and on post-progression patterns of care in patients with epidermal growth factor receptor activating mutation positive (EGFRm +) advanced non-small-cell lung cancer (NSCLC) -Reiwa- |
| Date of disclosure of the study information | 2019/11/26 |
| Last modified on | 2019/11/25 16:01:43 |
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Basic information
Public title
Real-world observational study on the efficacy and safety of first-line osimertinib treatment and on post-progression patterns of care in patients with epidermal growth factor receptor activating mutation positive (EGFRm +) advanced non-small-cell lung cancer (NSCLC) -Reiwa-
Acronym
CSPOR-LC07
Scientific Title
Real-world observational study on the efficacy and safety of first-line osimertinib treatment and on post-progression patterns of care in patients with epidermal growth factor receptor activating mutation positive (EGFRm +) advanced non-small-cell lung cancer (NSCLC) -Reiwa-
Scientific Title:Acronym
CSPOR-LC07
Region
| Japan |
Condition
Condition
Epidermal growth factor receptor activating mutation positive (EGFRm +) advanced non-small-cell lung cancer (NSCLC)
Classification by specialty
| Pneumology | Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
This study aims to evaluate the distribution of the use of EGFR-tyrosine kinase inhibitor(EGFR TKI) as first-line therapy, as well as the clinical efficacy and safety of osimetinib treatment in patients with epidermal growth factor receptor activating mutation positive (EGFRm +) advanced non-small-cell lung cancer (NSCLC).
It also confirms the pattern of progression when osimertinib becomes PD on RECIST, and investigates the clinical course and treatment status thereafter. We will also investigate the factors that make osimertinib less effective by checking medication adherence.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
PFS (time from initiation of osimerutinib treatment to RECIST PD or death from any cause)
Percentage of patients with the following progression patterns when osimertinib treatment results in RECIST PD. Patterns of progression are classified into nine categories (3x3) according to the following criteria for site of progression and patient status:
A. Exacerbation pattern for the site of exacerbation
(A1) brain metastases only
(A2) oligometastasis (one non-brain organ, 1-3 lesions)
(A3) Multiple organ exacerbations (other than A1 and A2)
B. Exacerbation patterns according to symptoms at exacerbation and the patient's general condition
(B1) Asymptomatic, no clinical progression defined by B3
(B2) Present symptoms, no clinical progression defined by B3
(B3) Reduced PS and/or threatened major organs (carcinomatous lymphangiosis, bone marrow metastases, carcinomatous meningitis, liver metastases with liver damage, etc.)
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(1)Patients diagnosed with advanced or recurrent non-small cell lung cancer prior to enrollment in the study.
* Use disease stages defined in the Union for International Cancer Control (UICC) TNM Classification of Lung Tumors (2017, 8th Edition).
(2)Patients diagnosed with positive EGFR mutations of any type.
In addition to Exon 19 deletion and Exon 21 L858R common mutations, rare EGFR mutations (uncommon mutation) are also eligible.
(3)Patients who have been treated with primary EGFR TKI since September 1, 2018, those who had been treated, and those who will be treated in the future.
1. Patients using anticancer agents as local therapy, such as pleurodesis, are also eligible.
2. Patients using cytotoxic anticancer agents as prior therapy are also eligible.
3. Patients treated in combination with EGFR-TKIs and other anticancer drugs or angiogenesis inhibitors are eligible.
4. Patients using single-agent EGFR-TKI as the mainstay treatment are eligible, even if it's a rotation therapy of EGFR-TKI and other anticancer agents.
5. Patients enrolled in other clinical trials are also eligible.
(1)Patients aged 20 years or older at the time of enrollment.
(2)Patients who have given written consent to this study (however, patients who have died at the time of enrollment will not need consent).
Key exclusion criteria
(1) atients whose treatment date for EGFR TKIs was prior to September 1, 2018.
Patients judged by the physician to be inappropriate for enrollment in the study.
(2) Patients judged by the physician to be inappropriate for enrollment in the study.
Target sample size
700
Research contact person
Name of lead principal investigator
| 1st name | Hideo |
| Middle name | |
| Last name | Kunitoh |
Organization
Japanese Red Cross Medical Center
Division name
Department of Internal Medicine
Zip code
150-8935
Address
4-1-22, Hiroo, Shibuya, Tokyo
TEL
03-3400-1311
kunito_hideo@med.jrc.or.jp
Public contact
Name of contact person
| 1st name | Akira |
| Middle name | |
| Last name | Yamao |
Organization
Public Health Research Foundation
Division name
Comprehensive Support Project for Oncology Research (CSPOR)
Zip code
169-0051
Address
1-1-7 Nishi-Waseda, Shinjuku-ku, Tokyo
TEL
03-5287-2636
Homepage URL
cspor-lc07@csp.or.jp
Sponsor or person
Institute
Public Health Research Foundation, Comprehensive Support Project for Oncology Research (CSPOR)
Institute
Department
Personal name
Funding Source
Organization
AstraZeneca K.K.
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
No
Address
4-1-22, Hiroo, Shibuya, Tokyo
Tel
03-3400-1311
no@mail
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
1 KKR札幌医療センター 腫瘍内科
2 北海道大学病院 腫瘍内科
3 岩手県立中央病院 呼吸器内科
4 東北大学病院 呼吸器内科
5 秋田赤十字病院 呼吸器内科
6 坪井病院 呼吸器内科
7 茨城県立中央病院 呼吸器内科
8 群馬県立がんセンター 呼吸器内科
9 さいたま赤十字病院 呼吸器内科
10 春日部市立医療センター 呼吸器内科
11 国立がん研究センター東病院 呼吸器内科
12 NTT東日本関東病院 呼吸器内科
13 がん・感染症センター都立駒込病院 呼吸器内科
14 杏林大学医学部付属病院 呼吸器内科
15 日本赤十字社医療センター 呼吸器内科
16 国立国際医療研究センター 呼吸器内科
17 昭和大学病院 呼吸器アレルギー内科
18 帝京大学医学部附属病院 腫瘍内科
19 東京医科大学病院 呼吸器・甲状腺外科
20 日本医科大学付属病院 呼吸器内科
21 虎の門病院 呼吸器センター 内科
22 東京都済生会中央病院 呼吸器内科
23 東邦大学医療センター大森病院 呼吸器内科
24 三井記念病院 呼吸器内科
25 北里大学病院 呼吸器内科
26 横浜市立市民病院 呼吸器内科
27 藤沢市民病院 外来化学療法室/呼吸器内科
28 神奈川県立がんセンター 呼吸器内科
29 新潟県立がんセンター新潟病院 内科
30 金沢大学附属病院 呼吸器内科
31 信州大学医学部附属病院 呼吸器・感染症・アレルギー内科
32 浜松医科大学医学部附属病院 呼吸器内科
33 名古屋大学医学部附属病院 呼吸器内科
34 大阪医科大学附属病院 呼吸器内科・呼吸器腫瘍内科
35 兵庫県立尼崎総合医療センター 呼吸器内科
36 岡山大学病院 呼吸器・アレルギー内科
37 県立広島病院 臨床腫瘍科
38 愛媛大学医学部附属病院
39 久留米大学病院 呼吸器・神経・膠原病内科
40 新古賀病院 呼吸器内科
41 長崎大学病院 呼吸器内科
42 熊本中央病院 腫瘍内科/呼吸器内科
43 国立病院機構 沖縄病院 呼吸器内科
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 11 | 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
Enrolling by invitation
Date of protocol fixation
| 2019 | Year | 09 | Month | 30 | Day |
Date of IRB
| 2019 | Year | 10 | Month | 25 | Day |
Anticipated trial start date
| 2019 | Year | 11 | Month | 22 | Day |
Last follow-up date
| 2022 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
NO
Management information
Registered date
| 2019 | Year | 11 | Month | 25 | Day |
Last modified on
| 2019 | Year | 11 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044061
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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