Imdelltra (tarlatamab-dlle)

P1/2, N=0, Withdrawn, National Cancer Institute (NCI) | N=120 --> 0 | Trial completion date: Dec 2030 --> Apr 2026 | Not yet recruiting --> Withdrawn | Trial primary completion date: Dec 2029 --> Apr 2026

P2, N=40, Recruiting, ETOP IBCSG Partners Foundation | N=30 --> 40

Tarlatamab demonstrates both intracranial and extracranial efficacy in our real-world patient cohort. Our cohort's toxicity profile showed similar CRS but higher ICANS rates compared with those reported in clinical trials. More studies are needed to determine biomarkers of efficacy and toxicity.

P1, N=200, Active, not recruiting, Amgen | Suspended --> Active, not recruiting

P2, N=48, Recruiting, ETOP IBCSG Partners Foundation | Not yet recruiting --> Recruiting | N=30 --> 48

She was treated with tarlatamab, achieving 4 months of treatment response with symptomatic relief and improved performance status. This case represents the first documented evidence of the clinical benefit of tarlatamab in transformed SCLC and highlights its therapeutic potential in this challenging setting.

The recent approval of the DLL3×CD3 bispecific T-cell engager tarlatamab represents one of the first meaningful advances in relapsed small cell lung cancer (SCLC) in decades, yet responses remain heterogeneous and resistance is inevitable...These findings underscore the clinical relevance of TF-defined molecular subtypes in human SCLC. More broadly, they highlight the power of integrating longitudinal in vivo plasma transcriptional profiling from patient plasma with functional mouse modeling to uncover clinical and biological mechanisms of response and resistance to cell-surface-targeted therapies.

P2, N=30, Not yet recruiting, ETOP IBCSG Partners Foundation

P1/2, N=35, Not yet recruiting, Academisch Ziekenhuis Maastricht

P1, N=160, Not yet recruiting, Amgen

Next-generation TCE platforms integrating conditional activation, cytokine payloads, and checkpoint modulation-deployed with biomarker-guided selection and TME-modulating combinations-represent a transformative therapeutic strategy. With tarlatamab's phase III survival benefit establishing clinical proof-of-concept, and pivotal trials underway for xaluritamig and next-generation agents, TCEs are positioned to become standard-of-care platform therapies in biomarker-defined solid tumours by 2028-2030.