NIPH Clinical Trials Search

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

Basic Information

Recruitment status	Recruiting
Health condition(s) or Problem(s) studied	Early non-small cell lung cancer
Date of first enrollment	05/12/2025
Target sample size	400
Countries of recruitment	United States of America,Japan,Argentina,Japan,Australia,Japan,Belgium,Japan,Brazil,Japan,Canada,Japan,Chile,Japan,China,Japan,Denmark,Japan,Egypt,Japan,France,Japan,Germany,Japan,Greece,Japan,Hong Kong,Japan,Israel,Japan,Italy,Japan,Mexico,Japan,Netherlands,Japan,Portugal,Japan,Romania,Japan,South Korea,Japan,Spain,Japan,Sweden,Japan,Taiwan,Japan,Turkey,Japan
Study type	Interventional
Intervention(s)	Drug: Zongertinib Drug: Pembrolizumab Drug: Atezolizumab Drug: Durvalumab Drug: Nivolumab

Outcome(s)

Primary Outcome	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	- 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

Key inclusion & exclusion criteria

Age minimum	>= 18age old
Age maximum	Not applicable
Gender	Both
Include 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...
Exclude 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...