A Phase 3, Open Label, Multicenter, Randomized Study of First Line Tarlatamab in combination with Durvalumab, Carboplatin and Etoposide versus Durvalumab, Carboplatin and Etoposide in Untreated Extensive Stage Small-Cell Lung Cancer (DeLLphi-312)

Condition studied

Extensive stage small cell lung cancer (ES-SCLC). Small-cell lung cancer, accounting for 10% to 15% of lung cancer (Rudin et al, 2015), is an aggressive lung cancer subtype with neuroendocrine differentiation and strongly associated with smoking (Koinis et al, 2016). It displays a distinct natural history characterized by a high growth fraction, rapid doubling time and early establishment of widespread metastatic lesions (Gustafsson et al, 2008). Around 70% of patients are diagnosed with ES-SCLC, presenting with distant metastasis or tumor or nodal volume that is too large to be encompassed in a tolerable radiation plan.

Investigational medicinal product(s)

Eligibility

Primary endpoint

OS, Progression free survival (BICR assessed)

Endpoint detail

PFS, OR, DC, DOR, PFS rate at 6 months, 1 year, and 2 years from randomization OS rate at 6 months, 1 year, 2 years, and 3 years from randomization TTP, Incidence of treatment-emergent adverse events, Serum concentrations of tarlatamab., Incidence of anti-tarlatamab antibody formation.