Actively Recruiting
A Randomized, Open-Label, Phase 3 Study of ZL-1310, a DLL3 Antibody-Drug Conjugate, Compared to Investigator's Choice Therapy in Participants With Relapsed Small Cell Lung Cancer
Led by Zai Lab (Shanghai) Co., Ltd. · Updated on 2026-05-14
480
Participants Needed
56
Research Sites
21 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
Researchers are evaluating the effectiveness and safety of ZL-1310 compared to the Investigator's Choice Therapy in adults with relapsed Small Cell Lung Cancer (SCLC). This is a Phase 3, randomized, open-label study sponsored by Zai Lab (Shanghai) Co., Ltd. It aims to assess how well ZL-1310, a DLL3 antibody-drug conjugate, works in patients whose cancer has progressed after initial treatments. Participants will be randomly assigned to receive either ZL-1310 as a single agent or the Investigator's Choice of Therapy, which includes treatments such as Topotecan, Lurbinectedin, or Amrubicin. Treatment will continue with close monitoring for up to 27 months to evaluate responses and survival outcomes. During the study, participants will undergo tumor biopsies or provide archived tumor tissue samples at screening. Researchers will measure objective response rates, overall survival, progression-free survival, duration and time to response, and any treatment-related side effects. Quality of life will also be tracked using standardized questionnaires. The study involves regular assessments and follows participants for up to 27 months to monitor outcomes and safety.
CONDITIONS
Brief 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 disease progression during or after the most recent therapy, or received second-line tarlatamab
- Measurable disease according to RECIST v1.1
- Participants with treated and stable or untreated and asymptomatic CNS metastases
- Adequate organ and marrow function
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Life expectancy of at least 3 months
- Willing to undergo tumor biopsy or provide archived tumor tissue at screening
- Able and willing to comply with study protocol for the duration of the study
You will not qualify if you...
- Received more than one line of systemic therapy for Extensive-Stage Small Cell Lung Cancer
- Prior treatment with any antibody-drug conjugate containing a topoisomerase 1 inhibitor
- Presence of another known malignancy except as defined in the protocol
- History or suspected interstitial lung disease or pneumonitis
- Severe lung problems from other illnesses
- Anti-cancer treatment within 3 weeks before first dose of study treatment
- Prior radiotherapy before study treatment as defined in the protocol
- Unresolved side effects of grade 2 or higher from previous cancer treatments except hair loss and skin discoloration
- Known or active infections as specified in the protocol
- Significant active cardiovascular disease or recent arterial thromboembolic event within 6 months before first dose of study treatment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 27 months
Participants receive either ZL-1310 or Investigator's Choice Therapy as treatment for relapsed small cell lung cancer.
Regular visits for treatment and assessments during the treatment period
Duration - Up to 27 months
Participants are monitored for overall survival, duration of response, progression-free survival, and safety outcomes after treatment ends.
Visits scheduled based on clinical need during follow-up
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
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15
Zai Lab Site 02010
Detroit, Michigan, United States, 48202
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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
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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
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23
Zai Lab Site 02029
Pittsburgh, Pennsylvania, United States, 15232
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24
Zai Lab Site 02036
Nashville, Tennessee, United States, 37203
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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
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32
Zai Lab Site 01011
Naning, Guangxi, China, 530021
Actively Recruiting
33
Zai Lab Site 01008
Shijiazhuang, Hebei, China
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34
Zai Lab Site 01010
Zhengzhou, Henan, China, 450052
Actively Recruiting
35
Zai Lab Site 01034
Wuhan, Hubei, China, 430079
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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
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43
Zai Lab Site 01017
Hangzhou, Zhejiang, China, 310000
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44
Zai Lab Site 01016
Taizhou, Zhejiang, China, 318000
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45
Zai Lab Site 10019
Kurume, Fukuoka, Japan, 830-0011
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46
Zai Lab Site 10015
Kashihara, Nara, Japan, 634-8522
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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
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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