An Open-label, Multicenter Study of ZL-1310 to Evaluate the Safety, Efficacy, and Pharmacokinetics in Participants With Small Cell Lung Cancer
Zai Lab (Shanghai) Co., Ltd.
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
Description
This is an open-label, ascending, multiple-dose, phase 1 study evaluating ZL-1310 as a single agent, in combination with Atezolizumab, and in combination with Atezolizumab and Carboplatin in subjects with extensive SCLC.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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…
Interventions
- DrugZL-1310
Drug: ZL-1310
- DrugAtezolizumab
Drug Atezolizumab
- DrugCarboplatin
Drug Carboplatin
Locations (38)
- Zai Lab Site 2005Duarte, California
- Zai Lab Site 2030New Haven, Connecticut
- Zai Lab Site 2026Sarasota, Florida
- Zai Lab Site 2013Detroit, Michigan
- Zai Lab Site 2001Hackensack, New Jersey
- Zai Lab Site 2002Buffalo, New York