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Life sciences · Phase 1 Trial

A Study of ZL-1310 in Subjects With Small Cell Lung Cancer

ClinicalTrials.gov · October 16, 2026

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What was studied

Phase 1 Trial.

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Source abstract

Registry record from ClinicalTrials.gov (NCT06179069). This is a study registration, not published results. Lead sponsor: Zai Lab (Shanghai) Co., Ltd.. Recruitment status: RECRUITING. Phase: PHASE1. Study type: INTERVENTIONAL. Enrollment: 339 participants (ESTIMATED). Conditions: SCLC. Interventions: DRUG: ZL-1310; DRUG: Atezolizumab; DRUG: Carboplatin. Primary outcome measures: Incidence of Dose Limiting Toxicities of ZL-1310 as a single agent (Part 1A), in combination with Atezolizumab (Part 1B), and in combination with atezolizumab and carboplatin (Part 1C) , up to 24 months; Incidence of Treatment Emergent Adverse-Events of ZL-1310 as a single agent (Part 1A), in combination with atezolizumab (Part 1B), and in combination with atezolizumab and carboplatin (Part 1C) , up to 24 months; Incidence of Serious Adverse Events of ZL-1310 as a single agent (Part 1A), in combination with atezolizumab (Part 1B), and in combination with atezolizumab and carboplatin (Part 1C) , up to 24 months; Incidence of Treatment Emergent Adverse Events of ZL-1310 as a single agent (Part 2), in combination with atezolizumab (Part 3) and in combination with atezolizumab and carboplatin (Part 4) , up to 24 months; Incidence of Serious Adverse-Events (SAEs) of ZL-1310 as a single agent (Part 2), in combination with atezolizumab (Part 3), and in combination with atezolizumab and carboplatin (Part 4) , up to 24 months; Antitumor activity per RECIST v1.1 by investigator's assessment of ZL-1310 as a single agent (Part 2), in combination with atezolizumab (Part 3), and in combination with atezolizumab and carboplatin (Part 4) , up to 24 months; Objective response rate (ORR) per RECIST v1.1 of ZL-1310 as a single agent (Part 2) and in combination with atezolizumab and carboplatin (Part 4) , up to 24 months; Disease control rate (DCR) per RECIST v1.1 of ZL-1310 in combination with atezolizumab , up to 24 months. Brief summary: An open-label, multicenter study of ZL-1310 as a single agent and in combination with Atezolizumab (with and without Carboplatin) to evaluate the safety, efficacy, and pharmacokinetics in subjects with small cell lung cancer

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