臨床研究等提出・公開システム

Date of registration	Dec. 05, 2025
Last modified on	July. 17, 2026
Trial ID	jRCT2031250554

Scientific Title	Beamion LUNG-3: A randomized, controlled, multi-center trial evaluating zongertinib as an adjuvant monotherapy compared with standard of care in patients with early-stage, resectable non-small cell lung cancer (Stage II-IIIB) harboring tyrosine kinase domainactivating HER2 mutations (Beamion LUNG-3)
Public Title	Beamion LUNG-3: A study to test whether zongertinib helps people with surgically removed, non-small cell lung cancer with HER2 mutations compared with standard treatment

Contact for Scientific Queries	Name	Ogawa Shintaro
	Affiliation	Boehringer Ingelheim
	Address	2-1-1, Osaki, Shinagawa-ku, Tokyo
	Telephone	+81-120-189-779
	E-mail	medchiken.jp@boehringer-ingelheim.com
Contact for Public Queries	Name	Yamagami Tomohiro
	Affiliation	Boehringer Ingelheim
	Address	2-1-1, Osaki, Shinagawa-ku, Tokyo
	Telephone	+81-120-189-779
	E-mail	medchiken.jp@boehringer-ingelheim.com

Recruitment status	Recruiting

Anticipated date of first enrollment		Dec. 05, 2025
Target sample size		400
Study Type		Interventional
Study Design	allocation	randomized controlled trial
	masking	open(masking not used)
	control	no treatment control/standard of care control
	assignment	parallel assignment
	purpose	treatment purpose
Key inclusion & exclusion criteria	Inclusion Criteria	1 Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial 2 Patients must be more than 18 years old or over the legal age of consent in their country 3 Histology and tumor sample: Histologically confirmed diagnosis of primary NSCLC etc...
	Exclusion Criteria	1. Diagnosis of NSCLC with mixed histology/positive neuroendocrine markers (synaptophysin/CD56) 2. Presence of any co-occurring actionable mutation for which there is an approved targeted therapy in the adjuvant/neoadjuvant setting (e.g. EGFR or ALK). Patients with non-activating EGFR mutations can be considered eligible 3. Incomplete or aborted surgical resection (R1 or greater) etc...
	Age Minimum	18age old over
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		Early non-small cell lung cancer
Intervention(s)		Drug: Zongertinib Drug: Pembrolizumab Drug: Atezolizumab Drug: Durvalumab Drug: Nivolumab
Primary Outcome(s)		Disease-free survival (DFS) by investigator's assessment.DFS is defined as the time from randomization until recurrence of tumor or death from any cause, whichever occurs earlier.
Secondary Outcome(s)		- Key secondary endpoint: Overall survival (OS), defined as the time from randomization until death from any cause - Occurrence of trial-related Adverse Events (AEs) more than Grade 3 from first treatment administration (or from randomization for patients in the observation arm) until the earliest of tumor recurrence or 3 years since treatment start

Primary Sponsor	Nippon Boehringer Ingelheim Co., Ltd.

Name of Certified Review Board	Saitama Medical University International Medical Center Clinical Trial IRB
Address	1397-1, Yamane, Hidaka city, Saitama, Saitama
Approval Status	Approval
Date of approval	Oct. 22, 2025

Plan to share IPD	Yes

Countries of Recruitment（Except Japan）	United States of America/Argentina/Australia/Belgium/Brazil/Canada/Chile/China/Denmark/Egypt/France/Germany/Greece/Hong Kong/Israel/Italy/Mexico/Netherlands/Portugal/Romania/South Korea/Spain/Sweden/Taiwan/Turkey

History of Changes

No	Publication date
3	July. 17, 2026	(this page)	Changes
2	Jan. 23, 2026	Detail	Changes
1	Dec. 05, 2025	Detail

List of change history