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

NCT07218146 | Recruiting Phase 3 FDA Drug

• 1 other identifier: ZL-1310-003
• Study Type: interventional
• Target: 480
• Locations: 3 countries
• Sites: 34

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.

Conditions

Small-cell Lung Cancer

Outcome Measures

Primary Outcomes (2)

• Confirmed objective response rate (ORR) assessed by Blinded Independent Central Review of ZL-1310 compared to Investigator's Choice Therapy (ICT)

  up to 27 months

• Overall survival of ZL-1310 compared to Investigator's Choice Therapy (ICT)

  up to 27 months

Secondary Outcomes (9)

• 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 27 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 27 months

• Confirmed ORR assessed by the investigator per RECIST v1.1 of ZL-1310 compared to Investigator's Choice Therapy (ICT)

  up to 27 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 27 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 27 months

Study Arms (2)

Arm 1

EXPERIMENTAL

ZL-1310 as a single agent

Drug: ZL-1310

Arm 2

ACTIVE COMPARATOR

Investigator's Choice of Therapy

Drug: Investigator's Choice of Therapy

Interventions

ZL-1310 DRUG

ZL-1310 as a single-agent

Arm 1

Investigator's Choice of Therapy DRUG

Topotecan, Lurbinectedin, or Amrubicin

Arm 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zai Lab (Shanghai) Co., Ltd.: lead
• Zai Lab (US) LLC: collaborator

Study Sites (34)

Zai Lab Site 02030

New Haven, Connecticut, 06519, United States

RECRUITING

Zai Lab Site 02045

Clermont, Florida, 34711, United States

RECRUITING

Zai Lab Site 02031

Orange City, Florida, 32763, United States

RECRUITING

Zai Lab Site 02020

Rockledge, Florida, 32955, United States

RECRUITING

Zai Lab Site 02026

Sarasota, Florida, 34232, United States

RECRUITING

Zai Lab Site 02021

Peoria, Illinois, 61615, United States

RECRUITING

Zai Lab Site 02049

Peoria, Illinois, 61637, United States

RECRUITING

Zai Lab Site 02041

Louisville, Kentucky, 40202, United States

RECRUITING

Zai Lab Site 02003

Bethesda, Maryland, 20817, United States

RECRUITING

Zai Lab Site 02022

Silver Spring, Maryland, 20904, United States

RECRUITING

Zai Lab Site 02023

Columbia, Missouri, 65201, United States

RECRUITING

Zai Lab Site 02009

St Louis, Missouri, 63128, United States

RECRUITING

Zai Lab Site 02040

The Bronx, New York, 10461, United States

RECRUITING

Zai Lab Site 02024

Cleveland, Ohio, 44106, United States

RECRUITING

Zai Lab Site 02035

Broomall, Pennsylvania, 19008, United States

RECRUITING

Zai Lab Site 02019

Media, Pennsylvania, 19063, United States

RECRUITING

Zai Lab Site 02008

Pittsburgh, Pennsylvania, 15212, United States

RECRUITING

Zai Lab Site 02029

Pittsburgh, Pennsylvania, 15232, United States

RECRUITING

Zai Lab Site 02036

Nashville, Tennessee, 37203, United States

RECRUITING

Zai Lab Site 02025

Austin, Texas, 78745, United States

RECRUITING

Zai Lab Site 02025

Odessa, Texas, 79761, United States

RECRUITING

Zai Lab Site 02006

Fairfax, Virginia, 22031, United States

RECRUITING

Zai Lab Site 01001

Guangzhou, Guangdong, 510080, China

RECRUITING

Zai Lab Site 01011

Naning, Guangxi, 530021, China

RECRUITING

Zai Lab Site 01010

Zhengzhou, Henan, 450052, China

RECRUITING

Zai Lab Site 01034

Wuhan, Hubei, 430079, China

RECRUITING

Zai Lab Site 01015

Nanchang, Jiangxi, 330029, China

RECRUITING

Zai Lab Site 01007

Jinan, Shandong, 250117, China

RECRUITING

Zai Lab Site 01005

Linyi, Shandong, 276000, China

RECRUITING

Zai Lab SIte 01026

Chengdu, Sichuan, 610041, China

RECRUITING

Zai Lab Site 01017

Hangzhou, Zhejiang, 310000, China

RECRUITING

Zai Lab Site 10003

Shimosuga, Tochigi, 321-0293, Japan

RECRUITING

Zai Lab Site 10017

Fukuoka, 812-8582, Japan

RECRUITING

Zai Lab Site 10013

Osaka, 541-8567, Japan

RECRUITING

MeSH Terms

Conditions

Small Cell Lung Carcinoma

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

ZL-1310-003 Study Team

CONTACT

(510)-316-3502; study-ZL-1310-003@zailaboratory.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 8, 2025
• First Posted: October 20, 2025
• Study Start: November 30, 2025
• Primary Completion (Estimated): June 30, 2028
• Study Completion (Estimated): November 30, 2028
• Last Updated: April 23, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (22); CN (9); JP (3)