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

Purpose

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.

Condition

  • Small-cell Lung Cancer

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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.

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Arm 1 		ZL-1310 as a single agent
  • Drug: ZL-1310
    ZL-1310 as a single-agent
Active Comparator
Arm 2 		Investigator's Choice of Therapy
  • Drug: Investigator's Choice of Therapy
    Topotecan, Lurbinectedin, or Amrubicin

Recruiting Locations

Zai Lab Site 02037
Aurora, Colorado 80045

Zai Lab Site 02030
New Haven, Connecticut 06519

Zai Lab Site 02045
Clermont, Florida 34711

Zai Lab Site 02031
Orange City, Florida 32763

Zai Lab Site 02020
Rockledge, Florida 32955

Zai Lab Site 02026
Sarasota, Florida 34232

Zai Lab Site 02052
St. Petersburg, Florida 33701-4553

Zai Lab Site 02051
West Palm Beach, Florida 33401

Zai Lab Site 02021
Peoria, Illinois 61615

Zai Lab Site 02049
Peoria, Illinois 61637

Zai Lab Site 02038
Iowa City, Iowa 52242

Zai Lab Site 02041
Louisville, Kentucky 40202

Zai Lab Site 02003
Bethesda, Maryland 20817

Zai Lab Site 02022
Silver Spring, Maryland 20904

Zai Lab Site 02010
Detroit, Michigan 48202

Zai Lab Site 02023
Columbia, Missouri 65201

Zai Lab Site 02009
St Louis, Missouri 63128

Zai Lab Site 02040
The Bronx, New York 10461

Zai Lab Site 02024
Cleveland, Ohio 44106

Zai Lab Site 02035
Broomall, Pennsylvania 19008

Zai Lab Site 02019
Media, Pennsylvania 19063

Zai Lab Site 02008
Pittsburgh, Pennsylvania 15212

Zai Lab Site 02029
Pittsburgh, Pennsylvania 15232

Zai Lab Site 02036
Nashville, Tennessee 37203

Zai Lab Site 02025
Austin, Texas 78745

Zai Lab Site 02046
Dallas, Texas 75390-9020

Zai Lab Site 02025
Odessa, Texas 79761

Zai Lab Site 02006
Fairfax, Virginia 22031

More Details

Status
Recruiting
Sponsor
Zai Lab (Shanghai) Co., Ltd.

Study Contact

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