UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061687 |
|---|---|
| Receipt number | R000070586 |
| Scientific Title | Optimization of Adjuvant Osimertinib for EGFR Mutant Stage II-III Non Squamous Non Small Cell Lung Cancer (A randomized phase III study) |
| Date of disclosure of the study information | 2026/05/26 |
| Last modified on | 2026/05/26 10:14:26 |
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Basic information
Public title
Optimization of Adjuvant Osimertinib for EGFR Mutant Stage II-III Non Squamous Non Small Cell Lung Cancer (A randomized phase III study)
Acronym
A phase III study on the optimization of adjuvant Osimertinib (JACTOP-01(OASIS)Trial)
Scientific Title
Optimization of Adjuvant Osimertinib for EGFR Mutant Stage II-III Non Squamous Non Small Cell Lung Cancer (A randomized phase III study)
Scientific Title:Acronym
A phase III study on the optimization of adjuvant Osimertinib (JACTOP-01(OASIS)Trial)
Region
| Japan |
Condition
Condition
EGFR Mutant Stage II-III Non Squamous Non Small Cell Lung Cancer
Classification by specialty
| Pneumology | Chest surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The aim of the study is to evaluate the non-inferiority of 40 mg/day Osimertinib compared with the standard 80 mg/day regimen in disease free survival in patients with EGFR mutant stage II to III non squamous NSCLC.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Phase III
Assessment
Primary outcomes
disease-free survival (DFS)
Key secondary outcomes
Overall survival (OS), central nervous system disease free survival (CNS-DFS), incidence of adverse events, incidence of serious adverse events, incidence of Osimertinib related cardiac dysfunction (ORCD), 3 year treatment completion rate, 1 year treatment completion rate, 3 year dose reduction rate of Osimertinib, 1 year dose reduction rate of Osimertinib, and QOL(EQ5D5L)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Standard treatment group: Osimertinib (80 mg/day) will be administered orally once daily for 3 years, starting on the day of treatment initiation.
Interventions/Control_2
Experimental treatment group: Osimertinib (40 mg/day) will be administered orally once daily for 3 years, starting on the day of treatment initiation.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Histologically confirmed non squamous non small cell lung cancer (NSCLC), including adenocarcinoma, large cell carcinoma (excluding large cell neuroendocrine carcinoma), or NSCLC of unknown histological type.
2) Diagnosed as TNM postoperative pathological stage II to III (not pN3).
3) Presence of EGFR exon 19 deletion or L858R mutation (any testing method allowed).
4) Complete resection (R0) following anatomical resection (segmentectomy or more extensive resection).
5) ECOG performance status (PS) of 0 to 1.
6) 18 years of age or older at the time of registration.
7) No prior treatment such as radiotherapy or chemotherapy, other than surgery. (Molecular targeted therapies and immune checkpoint inhibitors are considered chemotherapy.) Prior adjuvant pharmacotherapy is allowed if completed at least 3 years before registration. Prior hormonal therapy for other malignancies is allowed.
8) Interval from surgery to registration: 4 to 10 weeks (without) or 4 to 26 weeks (with) adjuvant platinum based chemotherapy. (based on the date of surgery; same weekday acceptable).
9) Within 14 days prior to registration (same weekday allowed), the most recent laboratory values meet all of the following:
- WBC 3,000 per mm3 or higher
- Hemoglobin 9.0 g/dL or higher
- Platelets at least 100,000 per mm3
- Total bilirubin no more than 2.0 mg/dL
- AST no more than 100 U/L
- ALT no more than 100 U/L
- Serum creatinine no more than 1.5 mg/dL
10) No evidence of interstitial lung disease or pulmonary fibrosis on CT.
11) Written informed consent obtained from the patient.
Key exclusion criteria
1) Active multiple primary malignancies (synchronous or metachronous with disease-free survival less than 2 years). Exceptions include malignancies with an expected 5-year relative survival rate of 95 percent or higher, such as: stage 0 to I adenocarcinoma of stomach, colon, or rectum; stage 0 esophageal cancer; stage 0 to II breast cancer; stage I endometrial cancer; stage I to II prostate cancer; stage 0 cervical cancer; stage I to III thyroid cancer; stage I renal cancer; non melanoma skin cancer; lentigo maligna without definitive diagnosis; or carcinoma in situ or equivalent (based on UICC TNM 9th edition or equivalent).
2) Active infection requiring systemic therapy, including tuberculosis.
3) Psychiatric conditions precluding study participation.
4) Ongoing systemic steroid therapy exceeding 10 mg per day (prednisolone equivalent). Other immunosuppressive agents may be allowed at investigator discretion.
5) Serious comorbid conditions, including:
- frequent transient ischemic attacks
- symptomatic heart failure, unstable angina, or myocardial infarction within 1 year
- clinically significant arrhythmias (including conduction disorders)
- gastrointestinal perforation, fistula, diverticulitis, or history within 1 year
- uncontrolled diabetes mellitus
- uncontrolled hypertension
6) Pregnant, possibly pregnant, within 28 days postpartum, or breastfeeding; men planning to conceive; or individuals of reproductive potential unwilling to use effective contraception.
7) Hypersensitivity or allergy to study drug or excipients.
8) Considered unsuitable for participation by investigator.
Target sample size
420
Research contact person
Name of lead principal investigator
| 1st name | Norihiko |
| Middle name | |
| Last name | Ikeda |
Organization
Tokyo Medical University
Division name
Department of Surgery
Zip code
160-0023
Address
6-7-1 Nishishinjuku, Shinjuku-ku, Tokyo
TEL
03-3342-6111
jactop-01@csp.or.jp
Public contact
Name of contact person
| 1st name | Ken |
| Middle name | |
| Last name | Onodera |
Organization
OASIS Coordinating Office
Division name
Tohoku University Department of Thoracic Surgery
Zip code
980-8575
Address
4-1, Seiryo-machi, Aoba-ku, Sendai, Miyagi
TEL
022-717-8521
Homepage URL
https://www.phrf.jp/csp/cspor/
jactop-01@csp.or.jp
Sponsor or person
Institute
Public Health Research Foundation
Institute
Department
Personal name
Funding Source
Organization
National Federation of Health Insurance Societies
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
JACTOP, Japan Cancer Treatment Optimization Group
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Review Board of The Cancer Institute Hospital of JFCR
Address
3-8-31 Ariake, Koto-ku, Tokyo 135-8550
Tel
03-3520-0111
med.shinsa@jfcr.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
北海道大学(北海道)Hokkaido University
弘前大学(青森県)Hirosaki University
岩手医科大学(岩手県)Iwate Medical University
東北大学(宮城県)Tohoku University
仙台厚生病院(宮城県)Sendai Kousei Hospital
東北医科薬科大学(宮城県)Tohoku Medical and Pharmaceutical University
秋田大学(秋田県)Akita University
山形大学(山形県)Yamagata University
山形県立中央病院(山形県)Yamagata Prefectural Central Hospital
福島県立医科大学(福島県)Fukushima Medical University
自治医科大学(栃木県)Jichi Medical University
獨協医科大学(栃木県)Dokkyo Medical University
埼玉医科大学国際医療センター(埼玉県)Saitama Medical University International Medical Center
埼玉医科大学総合医療センター(埼玉県)Saitama Medical Center
自治医科大学附属さいたま医療センター(埼玉県)Jichi Medical University Saitama Medical Center
国立がん研究センター東病院(千葉県)National Cancer Center Hospital East
千葉大学(千葉県)Chiba University
がん・感染症センター 都立駒込病院(東京都)Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital
がん研究会有明病院(東京都)The Cancer Institute Hospital of JFCR
杏林大学(東京都)Kyorin University
慶應義塾大学(東京都)Keio University
国立がん研究センター中央病院(東京都)National Cancer Center Hospital
国立国際医療センター(東京都)National Center for Global Health and Medicine
順天堂大学(東京都)Juntendo University
東京医科大学(東京都)Tokyo Medical University
東京慈恵会医科大学(東京都)The Jikei University School of Medicine
日本大学(東京都)Nihon University
帝京大学(東京都)Teikyo University
東邦大学(東京都)Toho University
虎の門病院(東京都)Toranomon Hospital
日本医科大学(東京都)Nippon Medical School
昭和医科大学(東京都)Showa Medical University
神奈川県立がんセンター(神奈川県)Kanagawa Cancer Center
新潟県立がんセンター(新潟県)Niigata Cancer Center Hospital
金沢大学(石川県)Kanazawa University
信州大学(長野県)Shinshu University
岐阜大学(岐阜県)Gifu University
聖隷三方原病院(静岡県)Seirei Mikatahara General Hospital
浜松医科大学(静岡県)Hamamatsu University School of Medicine
愛知県がんセンター(愛知県)Aichi Cancer Center
名古屋大学(愛知県)Nagoya University
名古屋市立大学(愛知県)Nagoya City University
三重大学(三重県)Mie University
京都大学(京都府)Kyoto University
京都府立医科大学(京都府)Kyoto Prefectural University of Medicine
大阪国際がんセンター(大阪府)Osaka International Cancer Institute
関西医科大学附属病院(大阪府)Kansai Medical University Hospital
近畿大学(大阪府)Kindai University
神戸大学(兵庫県)Kobe University
兵庫県立がんセンター(兵庫県)Hyogo Cancer Center
兵庫医科大学(兵庫県)Hyogo Medical University
岡山大学(岡山県)Okayama University
広島市立広島市民病院(広島県)Hiroshima City Hiroshima Citizens Hospital
広島大学(広島県)Hiroshima University
徳島大学(徳島県)Tokushima University
九州大学(福岡県)Kyushu University
九州がんセンター(福岡県)Kyushu Cancer Center
産業医科大学(福岡県)University of Occupational and Environmental Health, Japan
北九州市立医療センター(福岡県)Kitakyushu Municipal Medical Center
久留米大学(福岡県)Kurume University
福岡大学(福岡県)Fukuoka University
熊本大学(熊本県)Kumamoto University
済生会熊本病院(熊本県)Saiseikai Kumamoto Hospital
大分大学(大分県)Oita University
鹿児島大学(鹿児島県)Kagoshima University
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 05 | 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
Open public recruiting
Date of protocol fixation
| 2025 | Year | 12 | Month | 28 | Day |
Date of IRB
| 2026 | Year | 02 | Month | 26 | Day |
Anticipated trial start date
| 2026 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2034 | Year | 03 | 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
| 2026 | Year | 05 | Month | 26 | Day |
Last modified on
| 2026 | Year | 05 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070586
