DeLLphi-312 (NCT07005128) is a multicenter, randomized, open-label phase III trial comparing the bispecific T-cell engager tarlatamab plus durvalumab, carboplatin, and etoposide versus the standard regimen of durvalumab with carboplatin and etoposide in first-line treatment of previously untreated, extensive-stage small-cell lung cancer (ES-SCLC).
The primary objective is to assess whether the addition of tarlatamab improves overall survival (OS).
Eligible participants are adults (= 18 years) with histologically or cytologically confirmed ES-SCLC (AJCC 2017 Stage IV, or T3–T4 with extensive pulmonary tumor/nodal burden), measurable disease per RECIST 1.1, and suitability to receive the carboplatin/etoposide plus durvalumab first-line regimen.
Participants are randomized to receive either tarlatamab + durvalumab + carboplatin + etoposide (for four cycles, followed by tarlatamab and durvalumab) or the comparator arm durvalumab + carboplatin + etoposide (four cycles, followed by durvalumab).
Key secondary endpoints include safety/tolerability and additional efficacy measures.
The DeLLphi-312 study evaluates a new treatment combination for people with newly diagnosed, extensive-stage small-cell lung cancer.
Some participants receive the investigational drug tarlatamab together with durvalumab and chemotherapy (carboplatin + etoposide), while others receive the standard treatment of durvalumab with carboplatin and etoposide.
The main goal is to find out whether adding tarlatamab can extend overall survival.
Eligible adults are those with untreated extensive-stage small-cell lung cancer.
Participants are randomized to receive either the new combination or standard therapy.
The study also looks at safety and how well the disease responds to treatment.
