NCT06179069 A Study of ZL-1310 in Subjects With Small Cell Lung Cancer
| NCT ID | NCT06179069 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Zai Lab (Shanghai) Co., Ltd. |
| Condition | SCLC |
| Study Type | INTERVENTIONAL |
| Enrollment | 339 participants |
| Start Date | 2024-01-23 |
| Primary Completion | 2027-05-30 |
Trial Parameters
Eligibility Fast-Check
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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
Eligibility Criteria
Inclusion Criteria: * Signed informed consent * Participant with metastatic or extensive-stage small cell lung cancer (de novo, not transformed) and for Part 1A and 1B must have documented disease progression during or following a platinum-based chemotherapy regimen. For Part 1C and Part 4, no prior systemic treatment for SCLC (including chemoradiotherapy for limited-stage SCLC). For Part 1B backfill and Part 3, first-line setting: no prior systemic treatment for SCLC (including chemoradiotherapy for limited-stage SCLC); or, first-line maintenance setting: participants have received at least 4 cycles of 1L induction therapy with carboplatin or cisplatin, etoposide, and anti-PD-L1 inhibitor for ES-SCLC with ongoing CR, PR, or SD per RECIST v1.1 assessed by the investigator. For Part 2-1, participants must have received no more than 2 lines of prior therapies in the extensive-stage setting, and progressed on or after a platinum-based chemotherapy regimen AND an anti-DLL3 T-cell engager (