Small-cell Lung Cancer
Conditions
Brief summary
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.
Interventions
DRUGZL-1310
ZL-1310 as a single-agent
Topotecan or Amrubicin
Sponsors
Zai Lab (Shanghai) Co., Ltd.
Zai Lab (US) LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Confirmed objective response rate (ORR) assessed by Blinded Independent Central Review of ZL-1310 compared to Investigator's Choice Therapy (ICT) | up to 30 months |
| Overall survival of ZL-1310 compared to Investigator's Choice Therapy (ICT) | up to 30 months |
Secondary
| Measure | Time frame |
|---|---|
| Duration of response (DoR) assessed by BICR and by the investigator per RECIST v1.1 of ZL-1310 compared to Investigator's Choice Therapy (ICT) | up to 30 months |
| Progression-free survival (PFS) assessed by BICR and by the investigator per RECIST v1.1 of ZL-1310 compared to Investigator's Choice Therapy (ICT) | up to 30 months |
| Confirmed ORR assessed by the investigator per RECIST v1.1 of ZL-1310 compared to Investigator's Choice Therapy (ICT) | up to 30 months |
| Time to response (TTR) assessed by BICR and by the investigator per RECIST v1.1 of ZL-1310 compared to Investigator's Choice Therapy (ICT) | up to 30 months |
| Confirmed CNS response assessed by BICR per Response Assessment in Neuro-Oncology for Brain Metastases (RANO-BM) of ZL-1310 compared to Investigator's Choice Therapy (ICT) | up to 30 months |
| Occurrence of treatment-emergent adverse events (TEAEs) of ZL-1310 compared to Investigator's Choice Therapy (ICT) | up to 30 months |
| Changes from baseline in quality of life related parameters of ZL-1310 compared to Investigator's Choice Therapy (ICT) using EQ-5D-5L | up to 30 months |
| Changes from baseline in quality of life related parameters of ZL-1310 compared to Investigator's Choice Therapy (ICT) using EORTC-QLQ-C30 | up to 30 months |
| Changes from baseline in quality of life related parameters of ZL-1310 compared to Investigator's Choice Therapy (ICT) using EORTC-QLQ-LC13 | up to 30 months |
Countries
Austria, Belgium, China, Czechia, France, Germany, Greece, Italy, Japan, Netherlands, Poland, Spain, Turkey (Türkiye), United Kingdom, United States
Contacts
CONTACTZL-1310-003 Study Team
Outcome results
None listed