Clinical Trial

Trial Description

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 domain activating HER2 mutations

MOA: Zongertinib is an oral, selective HER2 TKI

Key Eligibility:

• Confirmed diagnosis of Stage II-IIIB (up to T4, max N2) Non-squamous (NSq) NSCLC who underwent complete surgical resection
  • Must use open/VATS techniques
  • Must be performed either as lobectomy, sleeve lobectomy, bi-lobectomy, or pneumonectomy, including systematic ipsilateral lymph node dissection
  • Unresectable T4 and/or N3 disease and/or M1 disease is excluded
  • Incomplete or aborted surgical resection (R1 or greater) are excluded
• Documented TKD activating HER2 mutation (preferably by NGS)
• Archival tumor tissue must be submitted to central lab to confirm HER2 status
  (FFPE block is preferred, 20-25 FFPE slides are acceptable)
• Prior to randomization, pts must have completed either 3-4 cycles of
  neoadjuvant plt-based chemo + immunotherapy or 4 cycles of adjuvant plt-based
  chemo tx
• Pre- or post-op radiation tx for the primary NSCLC diagnosis are excluded
• Any prior anticancer tx other than SoC neoadjuvant plt-based immunochemo tx
  or adjuvant plt-based chemo tx are excluded
• Pts with presence of co-occurring AGAs with approved targeted tx in the
  (neo)adjuvant setting (e.g. EGFR or ALK) are excluded
• Pts with non-activating EGFR mutations are eligible