A Study of ZL-1310 Versus Investigator's Choice of Therapy in Participants With Relapsed Small Cell Lung Cancer (DLLEVATE)
Sponsor: Zai Lab (Shanghai) Co., Ltd.
Sponsor score: 0
ClinicalTrials ID:NCT07218146
This study assesses the efficacy and safety of ZL-1310 versus Investigator's Choice Therapy in relapsed SCLC patients. Eligible participants are adults with confirmed SCLC, measurable disease, and adequate organ function. Interventions include ZL-1310 or therapies like Topotecan, Lurbinectedin, or Amrubicin. Participants must comply with study protocols and provide tumor samples.
Patient Parameters
| Parameter | Options |
|---|
Program Overview
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.
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- 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.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Zai Lab Site 02045 | 34711 | Clermont | Florida |
| Zai Lab Site 02031 | 32763 | Orange City | Florida |
| Zai Lab Site 02026 | 34232 | Sarasota | Florida |
| Zai Lab Site 02019 | 61615 | Peoria | Illinois |
| Zai Lab Site 02049 | 61637 | Peoria | Illinois |
| Zai Lab Site 02041 | 40202 | Louisville | Kentucky |
| Zai Lab Site 02003 | 20817 | Bethesda | Maryland |
| Zai Lab Site 02023 | 65201 | Columbia | Missouri |
| Zai Lab Site 02019 | 19063 | Media | Pennsylvania |
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