Boehringer Ingelheim launches three Phase III trials in hard-to-treat lung cancers

Phase III programme

Boehringer Ingelheim has initiated three Phase III trials: DAREON®‑Lung‑1 in small cell lung cancer (SCLC), DAREON®‑NEC‑1 in extrapulmonary neuroendocrine carcinoma (epNEC), and Beamion LUNG‑3 in resectable HER2 (ERBB2)‑mutant non‑small cell lung cancer (NSCLC).

DLL3 biomarker strategy and obrixtamig

DAREON®‑Lung‑1 and DAREON®‑NEC‑1 will evaluate obrixtamig, a DLL3/CD3 IgG‑like bispecific T‑cell engager, in DLL3‑positive patient populations to test whether adding obrixtamig improves outcomes versus current standards of care. Planned comparisons include obrixtamig plus atezolizumab and chemotherapy versus atezolizumab plus chemotherapy in first‑line extensive‑stage SCLC, and obrixtamig plus carboplatin and etoposide versus carboplatin and etoposide in first‑line unresectable locally advanced or metastatic DLL3‑positive epNEC.

Zongertinib moved into adjuvant setting

Beamion LUNG‑3 is a global randomized Phase III trial evaluating zongertinib as adjuvant monotherapy versus physician’s choice in patients with stage II–IIIB HER2‑mutant NSCLC who have undergone complete surgical resection and received neoadjuvant or adjuvant therapy, with disease‑free survival as a primary objective. Zongertinib is an irreversible HER2 tyrosine kinase inhibitor that spares wild‑type EGFR and is approved in several markets for advanced HER2‑mutant NSCLC.

Development context

Obrixtamig is being developed through a partnership with Oxford BioTherapeutics using the OGAP® platform and is under evaluation in multiple earlier‑phase trials. These Phase III starts form part of Boehringer Ingelheim’s broader precision oncology strategy to combine targeted, biomarker‑defined therapies with immune‑directing approaches for cancers with high unmet need.