Tests ZL-1310 against standard treatment in relapsed small cell lung cancer
Compares ZL-1310 with standard treatment in adults with returned small cell lung cancer.
Plain-language title generated from the registry record
Registry title: A Study of ZL-1310 Versus Investigator's Choice of Therapy in Participants With Relapsed Small Cell Lung Cancer (DLLEVATE)
Key facts
- Where
- Salzburg and Vienna, AustriaSee the 2 sites
- Phase
- Phase 3
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Which best describes your lung cancer?
- Has your cancer come back or got worse during or after treatment with platinum chemotherapy?
- Has your cancer spread to the brain?
Source: NCT07218146, who can take part
Where in Austria
- Uniklinikum Salzburg, Landeskrankenhaus, Universitatsklinik fur Innere Medizin III der PMU Department of Internal Medicine IIISalzburg, AustriaTaking people
- Medizinische Universitaet Wien - Allgemeines Krankenhaus der Stadt Wien (AKH)Vienna, AustriaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Zai Lab (Shanghai) Co., Ltd.
- Trial code
- NCT07218146
- Record updated
- 16 October 2026
- Original description
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.Read full original descriptionShow less
A Randomized, Open-Label, Phase 3 Study of ZL-1310, a DLL3 Antibody-Drug Conjugate (ADC), Compared to Investigator's Choice Therapy in Participants With Relapsed Small Cell Lung Cancer
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.
Inclusion: 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.
Exclusion: Received more than one line of systemic therapy for Extensive-Stage SCLC; Received any prior ADC with topoisomerase 1 inhibitor payload; 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; 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; 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; Known infection or active infection defined in the protocol.