UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051460 |
|---|---|
| Receipt number | R000058704 |
| Scientific Title | Multi-institutional study of Osimertinib dose-optimization in Non-small cell lung cancer patients with EGFR activating mutation aged 70 Years or older |
| Date of disclosure of the study information | 2023/06/28 |
| Last modified on | 2023/06/28 09:15:45 |
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Basic information
Public title
Multi-institutional study of Osimertinib dose-optimization with regression discontinuity design in Non-small cell lung cancer patients with Epidermal Growth Factor Receptor activating mutation aged 70 Years or older
Acronym
Multi-institutional study of Osimertinib dose-optimization with regression discontinuity design in Non-small cell lung cancer patients with Epidermal Growth Factor Receptor activating mutation aged 70 Years or older (MONEY Trial)
Scientific Title
Multi-institutional study of Osimertinib dose-optimization in Non-small cell lung cancer patients with EGFR activating mutation aged 70 Years or older
Scientific Title:Acronym
Multi-institutional study of Osimertinib dose-optimization in Non-small cell lung cancer patients with EGFR activating mutation aged 70 Years or older(MONEY Trial)
Region
| Japan |
Condition
Condition
EGFR activating mutation-positive untreated advanced or recurrent non-small cell lung cancer
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The aim of the study is to optimize treatment for elderly (70 years of age or older) patients with untreated advanced or recurrent EGFR mutation-positive non-small cell lung cancer. The optimal dose of osimertinib will be determined by a regression discontinuity design, in which 40 mg/day dosage will be used for those with 50 kg body weight or less, whereas conventional 80 mg/day will be used for heavier patients. The dose optimization would lead to less side effects, better quality of life, and drug cost reduction.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Phase III
Assessment
Primary outcomes
progression-free survival(PFS)
Key secondary outcomes
overall survival(OS), time to treatment failure (TTF), response rate (RR), incidence of adverse events, and QOL.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Patients with body weight of 50kg or less will be treated with osimertinib 40mg daily. Patients will be followed every 6 months after start of the treatment until December 2027.
Interventions/Control_2
Patients with body weight of more than 50kg will be treated with osimertinib 80mg daily. Patients will be followed up every 6 months after the start of treatment until December 2027.
Interventions/Control_3
For patients who refused dose assignment according to body weight will be treated with osimertinib 80mg daily, but will be analyzed according to their body weight. Patients will be followed up every 6 months after the start of treatment until December 2027.
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
| 70 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(1) Histologically or cytologically proven non-small cell lung cancer.
(2) EGFR activation mutation-positive, either exon19 partial deletion or exon21 L858R point mutation. Liquid biopsy allowed for detection of the mutation.
(3) Patients with either stage IV or stage III disease not amenable to radical chemoradiotherapy. Those with recurrent disease after curative surgery or definitive (chemo)radiotherapy are also eligible.
(4) Patients scheduled to be treated with osimertinib monotherapy.
(5) No prior systemic drug therapy for the disease. Patients with prior adjuvant chemotherapy are allowed; those with prior adjuvant EGFR-TKI are excluded.
(6) 70 years of age or older at the date of enrollment.
(7) Performance status must be 0, 1 or 2 according to ECOG criteria.
(8) Body weight of 25 kg or more, and less than 100 kg.
(9) Those without measurable lesions are allowed.
(10) No symptomatic brain metastases, meningeal carcinomatosis, or spinal metastases requiring radiation therapy or surgery. However, patients may be enrolled after appropriate local treatment.
(11) No exclusion criteria are set on laboratory values, if the attending physician judges that osimertinib can be safely administered.
(12) Patients who are currently participating or will participate in other clinical trials or observational studies could be enrolled into this study unless otherwise specified.
(13) Written informed consent obtained from the patient.
Key exclusion criteria
(1) Those with infection requiring systemic treatment.
(2) Those with obvious interstitial pneumonia diagnosed by chest CT scan; a history of radiation pneumonitis or organizing radiation pneumonitis in the irradiated field is allowed. The presence or absence of interstitial pneumonitis shall be judged by the attending physician.
(3) Those with concomitant or treated malignancy with possibility of recurrence within 2 years, which could affect assessment of the primary endpoint.
(4) Those with psychiatric disorder or symptoms that affect daily life, thereby make participation in the study difficult.
(5) Those with complications which are judged unsuitable for study participation, such as uncontrollable diabetes mellitus, uncontrollable hypertension, congestive heart failure, unstable angina pectoris, serious arrhythmia, severe cerebrovascular disease, etc.
(6) Those with other complications or pre-existing medical conditions that would make participation in this study difficult, as judged by the attending physician.
Target sample size
550
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 Medical Oncology
Zip code
150-8935
Address
4-1-22 Hiroo, Shibuya, Tokyo
TEL
03-3400-1311
cspor-lc09@csp.or.jp
Public contact
Name of contact person
| 1st name | Yoko |
| Middle name | |
| Last name | Tsukita |
Organization
MONEY Study Office
Division name
Tohoku University Graduate School of Medicine, Dept of Respiratory Medicine
Zip code
980-8574
Address
1-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi
TEL
022-717-8539
Homepage URL
cspor-lc09@csp.or.jp
Sponsor or person
Institute
Public Health Research Foundation
Institute
Department
Personal name
Funding Source
Organization
Public Health Research Foundation
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
No
Name of secondary funder(s)
No
IRB Contact (For public release)
Organization
Institutional Review Board of Japanese Red Cross Medical Center
Address
4-1-22 Hiroo, Shibuya, Tokyo
Tel
03-3400-1311
rinri@med.jrc.or.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
1.独立行政法人国立病院機構 北海道がんセンター
2.東北大学大学院 医学系研究科 内科病態学講座
3.秋田厚生医療センター
4.山形県立中央病院
5.筑波大学附属病院
6.栃木県立がんセンター
7.獨協医科大学病院
8.群馬県立がんセンター
9.国立病院機構 渋川医療センター
10.さいたま赤十字病院
11.春日部市立医療センター
12.国立がん研究センター中央病院
13.虎の門病院
14.東京都済生会中央病院
15.日本医科大学付属病院
16.がん・感染症センター 都立駒込病院
17.NTT東日本 関東病院
18.昭和大学病院
19.東邦大学医療センター大森病院
20.日本赤十字社医療センター
21.東京医科大学病院
22.国立国際医療研究センター病院
23.東京警察病院
24.杏林大学医学部付属病院
25.東海大学医学部付属八王子病院
26.横浜市立市民病院
27神奈川県立がんセンター
28.藤沢市民病院
29.新潟県立がんセンター新潟病院
30.黒部市民病院
31.金沢大学附属病院
32.信州大学医学部附属病院
33.岐阜市民病院
34.浜松医科大学医学部附属病院
35.名古屋大学医学部附属病院
36.関西電力病院
37.大阪医科薬科大学病院
38.関西医科大学附属病院
39.兵庫県立尼崎総合医療センター
40.鳥取大学医学部附属病院
41.岡山大学病院
42.福山市民病院
43.県立広島病院
44.広島大学病院
45.独立行政法人国立病院機構 呉医療センター・中国がんセンター
46.独立行政法人国立病院機構 四国がんセンター
47.愛媛大学医学部附属病院
48.国立病院機構九州医療センター
49.新古賀病院
50.長崎大学病院
51.国立病院機構 沖縄病院
52.済生会今治病院
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 06 | Month | 28 | 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
| 2023 | Year | 06 | Month | 21 | Day |
Date of IRB
| 2023 | Year | 06 | Month | 21 | Day |
Anticipated trial start date
| 2023 | Year | 06 | Month | 21 | Day |
Last follow-up date
| 2027 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 06 | Month | 27 | Day |
Last modified on
| 2023 | Year | 06 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058704
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| Registered date | File name |
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