A Study of ZL-1310 Versus Investigator's Choice of Therapy in Participants With Relapsed Small Cell Lung Cancer
Status and phase
Enrolling
Phase 3
Conditions
Small-cell Lung Cancer
Treatments
Drug: ZL-1310
Drug: Investigator's Choice of Therapy
Details and patient eligibility
About
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.
Enrollment
480 estimated patients
Sex
All
Ages
18+ years old
Volunteers
No Healthy Volunteers
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.
Trial design
Primary purpose
Treatment
Allocation
Randomized
Interventional model
Parallel Assignment
Masking
None (Open label)
480 participants in 2 patient groups
Arm 1
Experimental group
Description:
ZL-1310 as a single agent
Treatment:
Drug: ZL-1310
Arm 2
Active Comparator group
Description:
Investigator's Choice of Therapy
Treatment:
Drug: Investigator's Choice of Therapy
Trial contacts and locations
5
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Central trial contact
ZL-1310-003 Study Team
Data sourced from clinicaltrials.gov
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