DAREON®-36: Phase Ib/II trial of obrixtamig plus ZL-1310 ± atezolizumab for advanced SCLC, LCNEC-L, and epNEC (NCT07707895)

DAREON®-36: A Phase Ib/II, open-label, safety and tolerability trial of obrixtamig in combination with ZL-1310 in patients with poorly differentiated NEC 

*Patients with tumors with mixed histologies are eligible only if the neuroendocrine carcinoma/small cell component is predominant and represents at least 50% of the overall tumor tissue. ^†Excluding combined histologies. ^‡Patients with prior chemoradiotherapy for LS-SCLC must have been treated with curative intent and had a treatment-free interval of at least 6 months after the last chemotherapy, radiotherapy, or chemoradiotherapy before diagnosis of ES-SCLC to be eligible.
1L, first-line; 2L+, second-line or later; AE, adverse event; AESI, adverse event of special interest; CTCAE, Common Terminology Criteria for Adverse Events; DC, disease control; DLT, dose-limiting toxicity; DoR, duration of response; epNEC, extrapulmonary neuroendocrine carcinoma; ES-SCLC, extensive-stage small cell lung cancer; LCNEC-L, large cell neuroendocrine carcinoma of the lung; LS-SCLC, limited-stage small cell lung cancer; NEC, neuroendocrine carcinoma; OR, objective response; PFS, progression-free survival; SCLC, small cell lung cancer; TEAE, treatment-emergent adverse event.