DLLEVATE (ZL-1310-003, NCT07218146) is an international, multicenter, randomized, open-label phase 3 study evaluating zocilurtatug pelitecan (ZL-1310), a DLL3-directed antibody-drug conjugate, versus investigator's choice therapy in patients with relapsed small cell lung cancer (SCLC). Eligible adult patients have histologically or cytologically confirmed SCLC with documented disease progression following first-line platinum-based therapy or following second-line tarlatamab, an ECOG performance status of 0–1, and a life expectancy of at least three months. Measurable disease per RECIST v1.1 is required, and tumor tissue is obtained via biopsy or archived sample at screening. Primary endpoints are objective response rate (ORR) by BICR per RECIST v1.1 for the interim analysis and overall survival (OS) as the primary analysis. Key secondary endpoints include duration of response (DoR), progression-free survival (PFS), and safety. The study is sponsored by Zai Lab.
DLLEVATE is an international phase 3 study investigating the drug zocilurtatug pelitecan (also known as ZL-1310) in patients whose small cell lung cancer has returned or progressed. Zocilurtatug pelitecan is an antibody-drug conjugate that specifically targets a marker called DLL3 found on the surface of cancer cells. The study aims to find out whether this treatment works better than the standard therapy chosen by the treating physician. Adult patients whose cancer has progressed after platinum-based chemotherapy or after prior treatment with tarlatamab can take part. Participants are randomly assigned to one of two treatment groups. The study looks at how many patients respond to treatment and how long they live overall.
