No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
480 (estimated)
Sponsor
Zai Lab (Shanghai) Co., Ltd. · Industry
Who this trial is looking for
This trial is looking for adults with relapsed small cell lung cancer who have had previous treatments. Participants will receive either ZL-1310 or another treatment their doctor chooses.
Are You a Good Fit for This Trial?
Rules you outActive infectionInterstitial lung diseaseSevere pulmonary compromise
You may be able to join if
I am at least 18 years old.
I have signed informed consent.
I have been diagnosed with small cell lung cancer.
I have had disease progression after my last treatment.
I have measurable disease.
I have stable or asymptomatic brain metastases.
I have adequate organ and marrow function.
I am willing to provide a tumor sample.
You may not be able to join if
I have received more than one line of treatment for extensive-stage SCLC.
I have received any prior ADC with a specific drug type.
I have another known cancer that does not meet the exceptions.
I have a history of interstitial lung disease or pneumonitis.
I have severe breathing problems from other illnesses.
I received anti-cancer treatment within 3 weeks of starting this study.
I have unresolved toxicity from previous treatments.
I have an active infection.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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.
Trial Locations
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Facility
City
State
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Status
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…
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.
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