Actively Recruiting
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
Eligibility Criteria
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
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
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
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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