Unique ID issued by UMIN | UMIN000051460 |
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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 |
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
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)
Multi-institutional study of Osimertinib dose-optimization in Non-small cell lung cancer patients with EGFR activating mutation aged 70 Years or older
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)
Japan |
EGFR activating mutation-positive untreated advanced or recurrent non-small cell lung cancer
Pneumology |
Malignancy
NO
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.
Efficacy
Confirmatory
Phase III
progression-free survival(PFS)
overall survival(OS), time to treatment failure (TTF), response rate (RR), incidence of adverse events, and QOL.
Interventional
Parallel
Non-randomized
Open -no one is blinded
Dose comparison
3
Treatment
Medicine |
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.
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.
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.
70 | years-old | <= |
Not applicable |
Male and Female
(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.
(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.
550
1st name | Hideo |
Middle name | |
Last name | Kunitoh |
Japanese Red Cross Medical Center
Department of Medical Oncology
150-8935
4-1-22 Hiroo, Shibuya, Tokyo
03-3400-1311
cspor-lc09@csp.or.jp
1st name | Yoko |
Middle name | |
Last name | Tsukita |
MONEY Study Office
Tohoku University Graduate School of Medicine, Dept of Respiratory Medicine
980-8574
1-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi
022-717-8539
cspor-lc09@csp.or.jp
Public Health Research Foundation
Public Health Research Foundation
Non profit foundation
Japan
No
No
Institutional Review Board of Japanese Red Cross Medical Center
4-1-22 Hiroo, Shibuya, Tokyo
03-3400-1311
rinri@med.jrc.or.jp
NO
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
2023 | Year | 06 | Month | 28 | Day |
Unpublished
Enrolling by invitation
2023 | Year | 06 | Month | 21 | Day |
2023 | Year | 06 | Month | 21 | Day |
2023 | Year | 06 | Month | 21 | Day |
2027 | Year | 12 | Month | 31 | Day |
2023 | Year | 06 | Month | 27 | Day |
2023 | Year | 06 | Month | 28 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000058704
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