A Study of ZL-1310 Versus Investigator's Choice of Therapy in Participants With Relapsed Small Cell Lung Cancer

Zai Lab

Status and phase: Enrolling; Phase 3

Conditions: Small-cell Lung Cancer

Treatments: Drug: ZL-1310; Drug: Investigator's Choice of Therapy

Study type: Interventional

Funder types: Industry

Identifiers

NCT07218146

ZL-1310-003

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)

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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