A Study of ZL-1310 Versus Investigator's Choice of Therapy in Participants With Relapsed Small Cell Lung Cancer (DLLEVATE)
Recruiting now · Phase 3
Conditions studied: Small-cell Lung Cancer
In brief
The purpose of this study is to evaluate the efficacy and safety of ZL-1310 compared to Investigator's Choice Therapy in participants with relapsed Small Cell Lung Cancer.
Key facts
- Study ID
- NCT07218146
- Run by
- Zai Lab (Shanghai) Co., Ltd.
- People needed
- 480
- Starts
- 2025-11-30
- Expected to finish
- 2028-11-30
- Last updated by the study team
- 2026-07-20
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Age >/= 18 years, or considered an adult by local regulations, at the time of consent
- Signed informed consent
- Histologically or cytologically confirmed SCLC. Received 1L platinum-based systemic therapy and had documented disease progression during or after the most recent systemic therapy. Or received 2L tarlatamab is allowed.
- Measurable disease according to RECIST v1.1 as assessed by the investigator.
- Participants with a history of treated and stable or untreated and asymptomatic CNS metastases based on criteria per protocol.
- Adequate organ and marrow function
- Eastern Cooperative Group (ECOG) performance status of 0 or 1
- Life expectancy of at least 3 months
- Participants must be willing to undergo a tumor biopsy or provide archived tumor tissue sample at Screening
- Participants must be willing and able to comply with protocol for the duration of the study
You may not qualify if…
- Received more than one line of systemic therapy for Extensive-Stage SCLC.
- Received any prior ADC with topoisomerase 1 inhibitor payload
- Participants with another known malignancy with exceptions defined in the protocol.
- History or suspected ILD/pneumonitis based on criteria per protocol
- Clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses.
- Receipt of anti-cancer treatment known to treat cancers within 3 weeks before the first dose of study treatment.
- Prior radiotherapy before study treatment based on criteria per protocol
- Unresolved toxicity of Grade >/= 2 from previous anti-cancer treatment, except for alopecia and skin pigmentation.
- Known infection or active infection defined in the protocol.
- Clinically significant active cardiovascular disease or history of arterial thromboembolic event within 6 months prior to the first dose of study treatment based on criteria per protocol.
Where it is running
- Zai Lab Site 02033 — Sacramento, California, United States (enrolling)
- Zai Lab Site 02037 — Aurora, Colorado, United States (enrolling)
- Zai Lab Site 02030 — New Haven, Connecticut, United States (enrolling)
- Zai Lab Site 02045 — Clermont, Florida, United States (enrolling)
- Zai Lab Site 02031 — Orange City, Florida, United States (enrolling)
- Zai Lab Site 02020 — Rockledge, Florida, United States (enrolling)
- Zai Lab Site 02026 — Sarasota, Florida, United States (enrolling)
- Zai Lab Site 02052 — St. Petersburg, Florida, United States (enrolling)
- Zai Lab Site 02047 — Tampa, Florida, United States (enrolling)
- Zai Lab Site 02051 — West Palm Beach, Florida, United States (enrolling)
- Zai Lab Site 02021 — Peoria, Illinois, United States (enrolling)
- Zai Lab Site 02049 — Peoria, Illinois, United States (enrolling)
- Zai Lab Site 02038 — Iowa City, Iowa, United States (enrolling)
- Zai Lab Site 02041 — Louisville, Kentucky, United States (enrolling)
- Zai Lab Site 02003 — Bethesda, Maryland, United States (enrolling)
- Zai Lab Site 02022 — Silver Spring, Maryland, United States (enrolling)
- Zai Lab Site 02010 — Detroit, Michigan, United States (enrolling)
- Zai Lab Site 02023 — Columbia, Missouri, United States (enrolling)
- Zai Lab Site 02009 — St Louis, Missouri, United States (enrolling)
- Zai Lab Site 02040 — The Bronx, New York, United States (enrolling)
- Zai Lab Site 02024 — Cleveland, Ohio, United States (enrolling)
- Zai Lab Site 02035 — Broomall, Pennsylvania, United States (enrolling)
- Zai Lab Site 02019 — Media, Pennsylvania, United States (enrolling)
- Zai Lab Site 02008 — Pittsburgh, Pennsylvania, United States (enrolling)
- Zai Lab Site 02050 — La Jolla, California, United States (enrolling)
Full record on ClinicalTrials.gov
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