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A Study of ZL-1310 for Relapsed Small Cell Lung Cancer

This study, called DLLEVATE, is looking at a new drug called ZL-1310 for people with small cell lung cancer that has come back (relapsed). Researchers want to see if ZL-1310 works better and is safer than standard treatments like Topotecan, Lurbinectedin, or Amrubicin. ZL-1310 is an ADC, which stands for Antibody-Drug Conjugate. You might be able to join if you are at least 18 years old, have small cell lung cancer that has progressed after platinum-based therapy, or after tarlatamab. The study will measure how many people respond to the treatment and how long people live, over a period of up to 27 months. The current status of this study is unclear.

Study design
This study is comparing ZL-1310 to standard treatments. It plans to enroll 480 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for up to 27 months to measure how well the treatment works and overall survival.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07218146

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

Recruiting
PHASE3Ages 18+InterventionalTreatment
Zai Lab (Shanghai) Co., Ltd.
~480 participants
Updated 2026-08-17 on ClinicalTrials.gov
What's tested:ZL-1310Investigator's Choice of Therapy

At a glance

Recruiting sites
111 of 111 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Confirmed objective response rate (ORR) assessed by Blinded Independent Central Review of ZL-1310 compared to Investigator's Choice Therapy (ICT)
Measured over up to 30 months
+1 more outcome measured

Conditions

Small-cell Lung Cancer

Explore related trials

Lung Small Cell Carcinoma

Where it's being run

111 sites across 58 states
Spain13
Florida7
France6
Turkey (Türkiye)5
Pennsylvania4
Tokyo4
Japan4
Poland4

Who to contact

ZL-1310-003 Study Team
[email protected]
650-360-1601
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • 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