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

A Randomized, Open-Label, Phase 3 Study of ZL-1310, a DLL3 Antibody-Drug Conjugate (ADC), Compared to Investigator's Choice Therapy in Participants With Relapsed Small Cell Lung Cancer

PHASE3 · Zai Lab (Hong Kong), Ltd. · NCT07218146

This will test whether ZL-1310 works better than a doctor-selected therapy for adults whose small-cell lung cancer has returned after prior platinum-based treatment.

Quick facts

PhasePHASE3
Study typeInterventional
Enrollment480 (estimated)
Ages18 Years and up
SexAll
SponsorZai Lab (Hong Kong), Ltd. (industry)
Drugs / interventionstarlatamab
Locations34 sites (New Haven, Connecticut and 33 other locations)
Trial IDNCT07218146 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Adults (≥18) with histologically confirmed relapsed small-cell lung cancer after first-line platinum-based therapy, measurable disease by RECIST v1.1, ECOG 0–1, adequate organ function, and willingness to provide tumor tissue and comply with study procedures.

Not a fit: Patients who have received more than one prior line of systemic therapy for extensive-stage disease, have ECOG >1, inadequate organ function, or symptomatic/unstable brain metastases are unlikely to qualify or benefit from this trial.

Why it matters

Potential benefit: If successful, ZL-1310 could provide a more effective treatment option that controls disease and possibly extends survival for patients with relapsed small-cell lung cancer.

How similar studies have performed: Earlier-phase studies of ZL-1310 or related targeted/antibody-based approaches in relapsed SCLC have suggested preliminary activity but no definitive phase-3 level breakthroughs have been established to date.

Eligibility criteria

Show full inclusion / exclusion 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 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 this trial is running

New Haven, Connecticut and 33 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Small-cell Lung Cancer

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.