UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061476 |
|---|---|
| Receipt number | R000070344 |
| Scientific Title | A single arm phase III trial to evaluate the efficacy of Alectinib 300 mg BID as adjuvant therapy in resected ALK positive non small cell lung cancer in a Japanese population |
| Date of disclosure of the study information | 2026/05/07 |
| Last modified on | 2026/05/07 17:26:56 |
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Basic information
Public title
A single arm phase III trial to evaluate the efficacy of Alectinib 300 mg BID as adjuvant therapy in resected ALK positive non small cell lung cancer in a Japanese population
Acronym
JACTOP-02(J-ALINA)Trial
Scientific Title
A single arm phase III trial to evaluate the efficacy of Alectinib 300 mg BID as adjuvant therapy in resected ALK positive non small cell lung cancer in a Japanese population
Scientific Title:Acronym
JACTOP-02(J-ALINA)Trial
Region
| Japan |
Condition
Condition
ALK positive 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 efficacy and safety of Alectinib 300 mg BID as adjuvant therapy in patients with resected ALK positive non small cell lung cancer.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Phase III
Assessment
Primary outcomes
3 year disease free survival (DFS)
Key secondary outcomes
3 year overall survival (OS), 3 year central nervous system disease free survival (CNS-DFS), incidence of adverse events, and treatment discontinuation rate
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Patients will receive Alectinib 300mg BID for up to 2 years until disease recurrence or occurrence of unacceptable AEs.
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Histologically proven non small cell lung cancer, excluding neuroendocrine carcinoma, mucoepidermoid carcinoma, and adenoid cystic carcinoma.
2) Diagnosed as TNM postoperative pathological stage II to III (not pN3).
3) Those who underwent anatomical resection (segmentectomy or more extensive resection) with pathologically confirmed complete resection.
4) ALK fusion confirmed in preoperative or surgical specimens by immunohistochemistry, FISH, or multigene testing.
5) 18 years of age or older at the time of consent.
6) ECOG performance status of 0 to 2.
7) No prior treatment such as radiotherapy, chemotherapy, or immunotherapy, other than surgery.
8) No severe dysfunction of major organs including bone marrow, heart, lungs, liver, kidneys, and meet all of the following criteria:
A) White blood cell count of 3,000 per mm3 or higher
B) Absolute neutrophil count of 1,500 per mm3 or higher
C) Hemoglobin level of 9.0 g/dL or higher
D) Platelet count of 100,000 per mm3 or higher
E) Aspartate aminotransferase (AST) level below 100 IU/L
F) Alanine aminotransferase (ALT) level of 126 IU/L or lower
G) Total bilirubin level of 1.5 mg/dL or lower
H) Serum creatinine level of no more than 1.5 times the upper limit of normal
I) PaO2 of 60 torr or higher, or SpO2 of 90 percent or higher
9) At least 4 weeks and no more than 12 weeks after surgery.
10) Written informed consent obtained from the patient.
Key exclusion criteria
1) Those with active multiple primary cancers, including synchronous or metachronous multiple cancers with a disease-free interval of 2 years or less, excluding the following: clinically stage I prostate cancer; stage 0 or I laryngeal cancer with complete response after radiotherapy; or completely resected cancer with an expected 5-year relative survival rate of 95 percent or higher.
2) Those with unresolved postoperative complications.
3) Those with history of hypersensitivity to the protocol drug(s).
4) Those with gastrointestinal disorders that may affect oral intake, such as malabsorption syndrome.
5) Those who use or may need to use strong CYP3A inhibitors within 14 days prior to the first dose, or during Alectinib treatment through Week 3.
6) Those with active local infection requiring surgical intervention (e.g., drainage) or active systemic infection.
7) Those with active hepatitis B or hepatitis C infection. (Those who are positive for anti-HBs antibody and/or HBs antigen are allowed, if the viral load is below the limit of detection and there is no active hepatitis.)
8) Those with interstitial lung disease evident on CT. A history of radiation pneumonitis or organizing radiation pneumonitis in the irradiated field is allowed.
9) Pregnant or breastfeeding women, women of childbearing potential, or women within 28 days after delivery; men planning conception with a partner; those unwilling to use effective contraception during treatment.
10) Those with severe comorbid conditions.
11) Those with any other condition deemed inappropriate as judged by the attending physician.
Target sample size
112
Research contact person
Name of lead principal investigator
| 1st name | Tomoyoshi |
| Middle name | |
| Last name | Takenaka |
Organization
Kyushu University Hospital
Division name
Thoracic Surgery
Zip code
812-8582
Address
3-1-1 Maidashi, Higashi-ku, Fukuoka
TEL
092-642-5466
jactop-02@csp.or.jp
Public contact
Name of contact person
| 1st name | Taichi, Takuya |
| Middle name | |
| Last name | Matsubara, Watanabe |
Organization
J-ALINA Coordinating Office
Division name
Kyushu University Hospital, Thoracic Surgery; Nagoya City University Hospital, Thoracic Surgery
Zip code
812-8582 (Dr. Matsubara) 467-8601 (Dr. Watanabe)
Address
3-1-1 Maidashi, Higashi-ku, Fukuoka; 1 Azakawasumi, Mizuho, Mizuho, Nagoya, Aichi
TEL
092-642-5466
Homepage URL
https://www.phrf.jp/csp/cspor/
jactop-02@csp.or.jp
Sponsor or person
Institute
Public Health Research Foundation
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development, AMED
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Japan Cancer Treatment Optimization Group, JACTOP
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kyushu University Hospital Institutional Review Board for Clinical Trials
Address
3-1-1 Maidashi, Higashi-ku, Fukuoka
Tel
092-642-5082
byskenkyu@jimu.kyushu-u.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
北海道大学病院（北海道） Hokkaido University Hospital
弘前大学（青森） Hirosaki University
岩手医科大学（岩手） Iwate Medical University
東北大学病院（宮城） Tohoku University Hospital
仙台厚生病院（宮城） Sendai Kousei Hospital
東北医科薬科大学（宮城） Tohoku Medical and Pharmaceutical University
秋田大学（秋田） Akita University
山形大学医学部附属病院（山形） Yamagata University Hospital
山形県立中央病院（山形） Yamagata Prefectural Central Hospital
福島県立医科大学附属病院（福島） Fukushima Medical University Hospital
自治医科大学（栃木） Jichi Medical University
獨協医科大学（栃木） Dokkyo Medical University
埼玉医科大学国際医療センター（埼玉） Saitama Medical University International Medical Center
埼玉医科大学総合医療センター（埼玉） Saitama Medical Center
自治医科大学附属さいたま医療センター（埼玉） Jichi Medical University Saitama Medical Center
国立がん研究センター東病院（千葉） National Cancer Center Hospital East
千葉大学医学部附属病院（千葉） Chiba University Hospital
がん・感染症センター 都立駒込病院（東京） Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital
がん研究会有明病院（東京） The Cancer Institute Hospital of JFCR
杏林大学（東京） Kyorin University
慶應義塾大学病院（東京） Keio University Hospital
国立がん研究センター中央病院（東京） National Cancer Center Hospital
国立国際医療センター（東京） National Center for Global Health and Medicine
東京医科大学病院（東京） Tokyo Medical University Hospital
東京慈恵会医科大学附属病院（東京） The Jikei University Hospital
日本大学医学部附属板橋病院（東京） Nihon University Itabashi Hospital
帝京大学（東京） Teikyo University
東邦大学医療センター大森病院（東京） Toho University Omori Medical Center
虎の門病院（東京） Toranomon Hospital
日本医科大学付属病院（東京） Nippon Medical School Hospital
昭和医科大学（東京） Showa Medical University
神奈川県立がんセンター（神奈川） Kanagawa Cancer Center
聖マリアンナ医科大学（神奈川） St. Marianna University School of Medicine
新潟県立がんセンター新潟病院（新潟） Niigata Cancer Center Hospital
金沢大学（石川） Kanazawa University
信州大学医学部附属病院（長野） Shinshu University Hospital
岐阜大学医学部附属病院（岐阜） Gifu University Hospital
聖隷三方原病院（静岡） Seirei Mikatahara General Hospital
浜松医科大学（静岡） Hamamatsu University School of Medicine
静岡県立静岡がんセンター（静岡） Shizuoka Cancer Center
愛知県がんセンター（愛知） Aichi Cancer Center
名古屋大学医学部付属病院（愛知） Nagoya University Hospital
名古屋市立大学病院（愛知） Nagoya City University Hospital
藤田医科大学病院（愛知） Fujita Health University Hospital
三重大学医学部附属病院（三重） Mie University Hospital
京都大学（京都） Kyoto University
京都府立医科大学（京都） Kyoto Prefectural University of Medicine
大阪国際がんセンター（大阪） Osaka International Cancer Institute
関西医科大学附属病院（大阪） Kansai Medical University Hospital
近畿大学（大阪） Kindai University
神戸大学医学部附属病院（兵庫） Kobe University Hospital
兵庫県立がんセンター（兵庫） Hyogo Cancer Center
兵庫医科大学（兵庫） Hyogo Medical University
岡山大学病院（岡山） Okayama University Hospital
広島市立広島市民病院（広島） Hiroshima City Hiroshima Citizens Hospital
広島大学病院（広島） Hiroshima University Hospital
九州大学病院（福岡）Kyushu University Hospital
国立病院機構九州がんセンター（福岡） National Hospital Organization Kyushu Cancer Center
産業医科大学（福岡） University of Occupational and Environmental Health, Japan
北九州市立医療センター（福岡） Kitakyushu Municipal Medical Center
久留米大学（福岡） Kurume University
福岡大学（福岡） Fukuoka University
熊本大学病院（熊本） Kumamoto University Hospital
済生会熊本病院（熊本） Saiseikai Kumamoto Hospital
大分大学医学部附属病院（大分） Oita University Hospital
鹿児島大学（鹿児島） Kagoshima University
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 05 | Month | 07 | 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
Preinitiation
Date of protocol fixation
| 2025 | Year | 11 | Month | 28 | Day |
Date of IRB
| 2026 | Year | 03 | Month | 03 | Day |
Anticipated trial start date
| 2026 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2035 | Year | 02 | Month | 28 | 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 | 07 | Day |
Last modified on
| 2026 | Year | 05 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070344
