Actively Recruiting

Phase 3
Age: 18Years +
All Genders
NCT07218146

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

Led by Zai Lab (Shanghai) Co., Ltd. · Updated on 2026-05-14

480

Participants Needed

56

Research Sites

156 weeks

Total Duration

On this page

Sponsors

Z

Zai Lab (Shanghai) Co., Ltd.

Lead Sponsor

Z

Zai Lab (US) LLC

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older at the time of consent
  • Signed informed consent
  • Histologically or cytologically confirmed Small Cell Lung Cancer
  • Received first-line platinum-based systemic therapy with documented disease progression during or after most recent systemic therapy, or received second-line tarlatamab
  • Measurable disease per RECIST v1.1
  • History of treated and stable or untreated and asymptomatic CNS metastases allowed
  • Adequate organ and marrow function
  • Eastern Cooperative Group (ECOG) performance status 0 or 1
  • Life expectancy of at least 3 months
  • Willing to undergo tumor biopsy or provide archived tumor tissue at screening
  • Willing and able to comply with study protocol for duration
Not Eligible

You will not qualify if you...

  • Received more than one line of systemic therapy for extensive-stage Small Cell Lung Cancer
  • Prior antibody-drug conjugate with topoisomerase 1 inhibitor payload
  • Another known malignancy (exceptions defined in protocol)
  • History or suspected interstitial lung disease or pneumonitis
  • Clinically severe pulmonary compromise from other pulmonary illnesses
  • Anti-cancer treatment within 3 weeks before first study dose
  • Prior radiotherapy before study treatment (per protocol criteria)
  • Unresolved toxicity of Grade 2 or higher from previous anti-cancer treatment, except alopecia and skin pigmentation
  • Known or active infection per protocol
  • Clinically significant active cardiovascular disease or arterial thromboembolic event within 6 months before first study dose

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 56 locations

1

Zai Lab Site 02037

Aurora, Colorado, United States, 80045

Actively Recruiting

2

Zai Lab Site 02030

New Haven, Connecticut, United States, 06519

Actively Recruiting

3

Zai Lab Site 02045

Clermont, Florida, United States, 34711

Actively Recruiting

4

Zai Lab Site 02031

Orange City, Florida, United States, 32763

Actively Recruiting

5

Zai Lab Site 02020

Rockledge, Florida, United States, 32955

Actively Recruiting

6

Zai Lab Site 02026

Sarasota, Florida, United States, 34232

Actively Recruiting

7

Zai Lab Site 02052

St. Petersburg, Florida, United States, 33701-4553

Actively Recruiting

8

Zai Lab Site 02051

West Palm Beach, Florida, United States, 33401

Actively Recruiting

9

Zai Lab Site 02021

Peoria, Illinois, United States, 61615

Actively Recruiting

10

Zai Lab Site 02049

Peoria, Illinois, United States, 61637

Actively Recruiting

11

Zai Lab Site 02038

Iowa City, Iowa, United States, 52242

Actively Recruiting

12

Zai Lab Site 02041

Louisville, Kentucky, United States, 40202

Actively Recruiting

13

Zai Lab Site 02003

Bethesda, Maryland, United States, 20817

Actively Recruiting

14

Zai Lab Site 02022

Silver Spring, Maryland, United States, 20904

Actively Recruiting

15

Zai Lab Site 02010

Detroit, Michigan, United States, 48202

Actively Recruiting

16

Zai Lab Site 02023

Columbia, Missouri, United States, 65201

Actively Recruiting

17

Zai Lab Site 02009

St Louis, Missouri, United States, 63128

Actively Recruiting

18

Zai Lab Site 02040

The Bronx, New York, United States, 10461

Actively Recruiting

19

Zai Lab Site 02024

Cleveland, Ohio, United States, 44106

Actively Recruiting

20

Zai Lab Site 02035

Broomall, Pennsylvania, United States, 19008

Actively Recruiting

21

Zai Lab Site 02019

Media, Pennsylvania, United States, 19063

Actively Recruiting

22

Zai Lab Site 02008

Pittsburgh, Pennsylvania, United States, 15212

Actively Recruiting

23

Zai Lab Site 02029

Pittsburgh, Pennsylvania, United States, 15232

Actively Recruiting

24

Zai Lab Site 02036

Nashville, Tennessee, United States, 37203

Actively Recruiting

25

Zai Lab Site 02025

Austin, Texas, United States, 78745

Actively Recruiting

26

Zai Lab Site 02046

Dallas, Texas, United States, 75390-9020

Actively Recruiting

27

Zai Lab Site 02025

Odessa, Texas, United States, 79761

Actively Recruiting

28

Zai Lab Site 02006

Fairfax, Virginia, United States, 22031

Actively Recruiting

29

Zai Lab Site 01002

Hefei, Anhui, China, 230036

Actively Recruiting

30

Zai Lab Site 01014

Xiamen, Fujian, China, 361000

Actively Recruiting

31

Zai Lab Site 01001

Guangzhou, Guangdong, China, 510080

Actively Recruiting

32

Zai Lab Site 01011

Naning, Guangxi, China, 530021

Actively Recruiting

33

Zai Lab Site 01008

Shijiazhuang, Hebei, China

Actively Recruiting

34

Zai Lab Site 01010

Zhengzhou, Henan, China, 450052

Actively Recruiting

35

Zai Lab Site 01034

Wuhan, Hubei, China, 430079

Actively Recruiting

36

Zai Lab Site 01012

Nanjing, Jiangsu, China

Actively Recruiting

37

Zai Lab Site 01015

Nanchang, Jiangxi, China, 330029

Actively Recruiting

38

Zai Lab Site 01009

Xi'an, Shaanxi, China, 710061

Actively Recruiting

39

Zai Lab Site 01007

Jinan, Shandong, China, 250117

Actively Recruiting

40

Zai Lab Site 01005

Linyi, Shandong, China, 276000

Actively Recruiting

41

Zai Lab Site 01043

Shanghai, Shanghai Municipality, China, 200433

Actively Recruiting

42

Zai Lab SIte 01026

Chengdu, Sichuan, China, 610041

Actively Recruiting

43

Zai Lab Site 01017

Hangzhou, Zhejiang, China, 310000

Actively Recruiting

44

Zai Lab Site 01016

Taizhou, Zhejiang, China, 318000

Actively Recruiting

45

Zai Lab Site 10019

Kurume, Fukuoka, Japan, 830-0011

Actively Recruiting

46

Zai Lab Site 10015

Kashihara, Nara, Japan, 634-8522

Actively Recruiting

47

Zai Lab Site 10014

Izumi, Osaka, Japan, 594-0073

Actively Recruiting

48

Zai Lab Site 10010

Shizuoka, Sunto-gun, Japan, 411-8777

Actively Recruiting

49

Zai Lab Site 10003

Shimosuga, Tochigi, Japan, 321-0293

Actively Recruiting

50

Zai Lab Site 10008

Bunkyō-Ku, Tokyo, Japan, 113-8603

Actively Recruiting

51

Zai Lab Site 10006

Bunkyō-Ku, Tokyo, Japan, 113-8677

Actively Recruiting

52

Zai Lab Site 10005

Koto-Ku, Tokyo, Japan, 135-8550

Actively Recruiting

53

Zai Lab Site 10007

Shinjuku-Ku, Tokyo, Japan, 162-8655

Actively Recruiting

54

Zai Lab Site 10018

Fukuoka, Japan, 810-8563

Actively Recruiting

55

Zai Lab Site 10017

Fukuoka, Japan, 812-8582

Actively Recruiting

56

Zai Lab Site 10013

Osaka, Japan, 541-8567

Actively Recruiting

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Research Team

Z

ZL-1310-003 Study Team

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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