UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000063475 |
|---|---|
| Receipt number | R000072595 |
| Scientific Title | Observational study of zongertinib in patients with HER2-mutated NSCLC in Japan (J-HERZ) |
| Date of disclosure of the study information | 2026/10/30 |
| Last modified on | 2026/10/30 11:15:10 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Observational study of zongertinib in patients with HER2-mutated NSCLC in Japan (J-HERZ)
Acronym
J-HERZ
Scientific Title
Observational study of zongertinib in patients with HER2-mutated NSCLC in Japan (J-HERZ)
Scientific Title:Acronym
J-HERZ
Region
| Japan |
Condition
Condition
HER2-mutated NSCLC
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To assess the rwORR of zongertinib as 1L treatment in Japanese patients with HER2-mutated NSCLC,including subgroup analyses by HER2 mutation subtype(TKD and non-TKD mutations).
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
rwORR in the zongertinib 1L group
Key secondary outcomes
-rwORR in the zongertinib 2L group
-rwORR in the zongertinib 3L group
-rwDCR in the zongertinib 1L group (including the TKD and non-TKD subgroups),2L group and 3L group
-rwPFS in the zongertinib 1L group (including the TKD and non-TKD subgroups),2L group and 3L group
-rwOS in the zongertinib 1L group (including the TKD and non-TKD subgroups),2L group and 3L group
-rwTTF in the zongertinib 1L group (including the TKD and non-TKD subgroups),2L group and 3L group
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(1)Patients aged >= 18 years
(2)Patients with metastatic or locally advanced NSCLC
(3)Patients confirmed to be HER2 mutation-positive, as documented by a medical institution
(4)Patients who have received or are scheduled to receive zongertinib based on the package insert
(5)Patients who provided consent to participate in the study on or after the date of approval of the study conduct at each participating institution, through one of the following procedures
A) Patients who, or whose legally acceptable representative,
provided written informed consent for participation.
B) For patients transferred to another hospital,
written informed consent is not mandatory,
and registration through verbal informed consent will be permitted.
C) Patients for whom written or verbal informed consent cannot be obtained
because they are deceased or cannot be contacted by the Investigators
can be enrolled through an opt-out procedure.
Key exclusion criteria
(1)Patients for whom first-time zongertinib treatment is on or after fourth-line (4L) treatment.
(2)Patients who have received zongertinib as an investigational drug.
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Shukuya |
| Middle name | |
| Last name | Takehito |
Organization
Juntendo University Hospital
Division name
Department of Respiratory Medicine
Zip code
113-8431
Address
3-1-3 Hongo, Bunkyo-ku, Tokyo
TEL
03-3813-3111
tshukuya@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | Shoko |
| Middle name | |
| Last name | Tsutsumi |
Organization
Mebix, Inc.
Division name
Research Promotion Group
Zip code
105-0001
Address
Toranomon 33 Mori Building 3-8-21 Toranomon, Minato-ku, Tokyo
TEL
03-4362-4500
Homepage URL
Lung_Cancer_Registry_NBI@mebix.co.jp
Sponsor or person
Institute
Nippon Boehringer Ingelheim Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Nippon Boehringer Ingelheim Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
The Japan Lung Cancer Society
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Research Ethics Committee Faculty of Medicine, Juntendo University
Address
3-1-3 Hongo, Bunkyo-ku, Tokyo
Tel
03-5802-1584
hongo-rinri@juntendo.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
順天堂大学医学部附属順天堂医院（東京都）
Juntendo University Hospital（Tokyo）
札幌医科大学附属病院（北海道）
Sapporo Medical University Hospital(Hokkaido)
医療法人渓仁会 手稲渓仁会病院（北海道）
Teine Keijinkai Hospital(Hokkaido)
社会福祉法人函館厚生院函館五稜郭病院（北海道）
Hakodate Goryoukaku Hospital(Hokkaido)
旭川医科大学病院（北海道）
Asahikawa Medical University Hospital(Hokkaido)
山形県立中央病院（山形県）
Yamagata Prefectural Central Hospital(Yamagata)
弘前大学医学部附属病院（青森県）
Hirosaki University Hospital(Aomori)
宮城県立がんセンター（宮城県）
Miyagi Cancer Center(Miyagi)
東北医科薬科大学病院（宮城県）
Tohoku Medical and Pharmaceutical University Hospital(Miyagi)
山形大学医学部附属病院（山形県）
Yamagata University Hospital(Yamagata)
岩手医科大学附属病院（岩手県）
Iwate Medical University Hospital(Iwate)
富山大学附属病院（富山県）
Toyama University Hospital(Toyama)
富山県立中央病院（富山県）
Toyama Prefectural Central Hospital(Toyama)
福井大学医学部附属病院（福井県）
University of Fukui Hospital(Fukui)
独立行政法人国立病院機構金沢医療センター（石川県）
National Hospital Organization Kanazawa Medical Center(Ishikawa)
金沢大学附属病院（石川県）
Kanazawa University Hospital(Ishikawa)
独立行政法人国立病院機構近畿中央呼吸器センター（大阪府）
NHO Kinki Chuo Chest Medical Center(Osaka)
香川大学医学部附属病院（香川県）
Kagawa University Hospital(Kagawa)
広島大学病院（広島県）
Hiroshima University Hospital(Hiroshima)
鳥取大学医学部附属病院（鳥取県）
Tottori University Hospital(Tottori)
徳島大学病院（徳島県）
Tokushima University Hospital(Tokushima)
高知大学医学部附属病院（高知県）
Kochi Medical School Hospital(Kochi)
山口大学医学部附属病院（山口県）
Yamaguchi University Hospital(Yamaguchi)
島根大学医学部附属病院（島根県）
Shimane University Hospital(Shimane)
愛知県がんセンター（愛知県）
Aichi Cancer Center(Aichi)
神戸市立医療センター中央市民病院（兵庫県）
Kobe City Medical Center General Hospital(Hyogo)
近畿大学病院（大阪府）
Kindai University Hospital(Osaka)
和歌山県立医科大学附属病院（和歌山県）
Wakayama Medical University Hospital(Wakayama)
社会福祉法人恩賜財団 済生会熊本病院（熊本県）
Saiseikai Kumamoto Hospital(Kumamoto)
地方独立行政法人東京都立病院機構がん・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(Tokyo)
新潟県立がんセンター新潟病院（新潟県）
Niigata Cancer Center Hospital(Niigata)
国立研究開発法人国立がん研究センター中央病院（東京都）
National Cancer Center Japan(Tokyo)
佐賀大学医学部附属病院（佐賀県）
Saga University Hospital(Saga)
聖マリアンナ医科大学病院（神奈川県）
St. Marianna University Hospital(Kanagawa)
鹿児島大学病院（鹿児島県）
Kagoshima University Hospital(Kagoshima)
岐阜大学医学部附属病院（岐阜県）
Gifu University Hospital(Gifu)
自治医科大学附属病院（栃木県）
Jichi Medical University Hospital(Tochigi)
浜松医科大学医学部附属病院（静岡県）
Hamamatsu University Hospital(Shizuoka)
関西医科大学附属病院（大阪府）
Kansai Medical University Hospital(Osaka)
岡山大学病院（岡山県）
Okayama University Hospital(Okayama)
医療法人王子総合病院（北海道）
Oji General Hospital(Hokkaido)
帯広厚生病院（北海道）
Obihiro Kosei Hospital(Hokkaido)
福島県立医科大学附属病院（福島県）
Fukushima Medical University Hospital(Fukushima)
地方独立行政法人北九州市立病院機構北九州市立医療センター（福岡県）
Kitakyushu Municipal Medical Center(Fukuoka)
北海道大学病院（北海道）
Hokkaido University Hospital(Hokkaido)
東京医科大学病院（東京都）
Tokyo Medical University Hospital(Tokyo)
国立大学法人信州大学医学部附属病院（長野県）
Shinshu University Hospital(Nagano)
愛媛大学医学部附属病院（愛媛県）
Ehime University Hospital(Ehime)
地方独立行政法人大阪市民病院機構大阪市立総合医療センター（大阪府）
Osaka City General Hospital(Osaka)
神奈川県立がんセンター（神奈川県）
Kanagawa Cancer Center(Kanagawa)
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 10 | Month | 30 | 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
| 2026 | Year | 07 | Month | 24 | Day |
Date of IRB
| 2026 | Year | 10 | Month | 27 | Day |
Anticipated trial start date
| 2026 | Year | 11 | Month | 17 | Day |
Last follow-up date
| 2031 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
To evaluate the real-world effectiveness and safety of zongertinib in patients with HER2 mutation-positive NSCLC treated with zongertinib, stratified by treatment line and HER2 mutation subtype.
Management information
Registered date
| 2026 | Year | 10 | Month | 30 | Day |
Last modified on
| 2026 | Year | 10 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072595
