ZL-1310 versus doctor-selected therapy for relapsed small-cell lung cancer (DLLEVATE)

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

DLLEVATE is a randomized, phase 3 trial comparing the experimental drug ZL-1310 to an investigator's choice of standard therapies in participants with relapsed small-cell lung cancer. Participants must have measurable disease, acceptable organ function, ECOG performance status 0–1, and be willing to provide tumor tissue for testing. The trial measures both efficacy (tumor response and survival endpoints) and safety outcomes while allowing some patients with stable or asymptomatic brain metastases. Treatments are given at designated Zai Lab study sites in the United States with regular clinical and imaging follow-up per protocol.

Why it matters

Who can join: the full rules

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.

Where it's running

• University of California San Diego
  La Jolla, California, United States Recruiting
• UC Davis Comprehensive Cancer Center
  Sacramento, California, United States Recruiting
• University of Colorado
  Aurora, Colorado, United States Recruiting
• Yale Cancer Center/Clinical Trials Office
  New Haven, Connecticut, United States Recruiting
• Clermont Oncology Center
  Clermont, Florida, United States Recruiting
• Mid Florida Hematology and Oncology Center
  Orange City, Florida, United States Recruiting

+115 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: ZL-1310-003 Study Team
• Email: study-ZL-1310-003@zailaboratory.com
• Phone: 650-360-1601

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.