Beamion LUNG-3 study evaluates whether zongertinib, an oral HER2-targeted treatment, can improve outcomes compared with standard adjuvant treatment in adults with completely resected Stage II-IIIB non-small cell lung cancer (NSCLC) whose tumors have activating HER2 tyrosine kinase domain (TKD) mutations. Eligible participants must have undergone curative-intent surgery and received guideline-appropriate perioperative systemic therapy, either neoadjuvant platinum-based chemotherapy with or without immunotherapy, or adjuvant platinum-based chemotherapy. Participants are randomized 1:1 to receive zongertinib or standard of care, which may consist of approved adjuvant immunotherapy or active surveillance, based on local practice guidelines. The main purpose of the study is to determine whether zongertinib can prolong disease-free survival compared to standard treatment. Safety and patient-reported outcomes are also assessed.
This is a global, randomized, open-label, Phase 3 study designed to assess the efficacy and safety of zongertinib as adjuvant therapy in participants with completely resected Stage II-IIIB NSCLC and HER2 TKD-activating mutations. Participants must have undergone complete resection and received perioperative systemic therapy consistent with current standards, including either neoadjuvant platinum-based chemotherapy with or without immunotherapy, or adjuvant platinum-based chemotherapy. After completing surgery and required systemic treatment, eligible participants are randomized 1:1 to receive either Zongertinib taken orally once daily for up to 3 years, or standard treatment, which may include an approved adjuvant immunotherapy agent administered according to its label, or observation, depending on local clinical practice and patient status. The primary objective is to evaluate whether zongertinib improves disease-free survival (DFS) compared with standard treatment. Secondary objectives include overall survival (OS), safety, tolerability, and patient-reported outcomes.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
400
Zongertinib
Pembrolizumab
Atezolizumab
Durvalumab
Nivolumab
ClinRé 001-022 (Premier Cancer Care and Infusion Center)
Fresno, California, United States
RECRUITINGOPN Healthcare, Inc.
Glendale, California, United States
RECRUITINGUniversity of California Irvine
Irvine, California, United States
NOT_YET_RECRUITINGSutter Health
Roseville, California, United States
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
Time frame: up to 8 years and 5 months
Key secondary endpoint: Overall survival (OS), defined as the time from randomization until death from any cause
Time frame: up to 8 years and 5 months
Occurrence of trial-related Adverse Events (AEs) ≥ 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
AEs are graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 5.0
Time frame: up to 3 years
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University of California San Francisco
San Francisco, California, United States
NOT_YET_RECRUITINGSarcoma Oncology Center
Santa Monica, California, United States
NOT_YET_RECRUITINGUniversity of California Los Angeles
Santa Monica, California, United States
RECRUITINGNorthern California Kaiser Permanente
Vallejo, California, United States
NOT_YET_RECRUITINGGeorge Washington University Cancer Center
Washington D.C., District of Columbia, United States
NOT_YET_RECRUITINGMid Florida Hematology and Oncology Center
Orange City, Florida, United States
RECRUITING...and 189 more locations