RecruitingRecruiting
A Study of ZL-1310 Versus Investigator's Choice of Therapy in Participants With Relapsed Small Cell Lung Cancer (DLLEVATE)
NCT07218146 · Zai Lab (Hong Kong), Ltd.
In plain English
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Official title
A Randomized, Open-Label, Phase 3 Study of ZL-1310, a DLL3 Antibody-Drug Conjugate (ADC), Compared to Investigator's Choice Therapy in Participants With Relapsed Small Cell Lung Cancer
About this study
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.
Eligibility criteria
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
Enrollment target: 480 participants
Allocation: randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2025-11-30
Estimated completion: 2028-11-30
Last updated: 2026-07-20
Interventions
Drug: ZL-1310Drug: Investigator's Choice of Therapy
Primary outcomes
- • 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)
Sponsor
Zai Lab (Shanghai) Co., Ltd. · industry
With: Zai Lab (US) LLC
Contacts & investigators
ContactZL-1310-003 Study Team · contact · study-ZL-1310-003@zailaboratory.com · 650-360-1601
All locations (76)
Zai Lab Site 02050Recruiting
La Jolla, California, United States
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Sacramento, California, United States
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Aurora, Colorado, United States
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New Haven, Connecticut, United States
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Clermont, Florida, United States
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Orange City, Florida, United States
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Rockledge, Florida, United States
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Sarasota, Florida, United States
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St. Petersburg, Florida, United States
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Tampa, Florida, United States
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West Palm Beach, Florida, United States
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Peoria, Illinois, United States
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Peoria, Illinois, United States
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Iowa City, Iowa, United States
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Louisville, Kentucky, United States
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Bethesda, Maryland, United States
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Silver Spring, Maryland, United States
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Detroit, Michigan, United States
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Columbia, Missouri, United States
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St Louis, Missouri, United States
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The Bronx, New York, United States
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Cleveland, Ohio, United States
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Broomall, Pennsylvania, United States
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Media, Pennsylvania, United States
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Pittsburgh, Pennsylvania, United States
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Pittsburgh, Pennsylvania, United States
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Nashville, Tennessee, United States
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Austin, Texas, United States
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Dallas, Texas, United States
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Odessa, Texas, United States
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Fairfax, Virginia, United States
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Salzburg, Austria
Zai Lab Site 01002Recruiting
Hefei, Anhui, China
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Xiamen, Fujian, China
Zai Lab Site 01001Recruiting
Guangzhou, Guangdong, China
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Naning, Guangxi, China
Zai Lab Site 01022Recruiting
Heilongjiang, Harbin, China
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Shijiazhuang, Hebei, China
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Zhengzhou, Henan, China
Zai Lab Site 01034Recruiting
Wuhan, Hubei, China
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Nanjing, Jiangsu, China
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Nanchang, Jiangxi, China
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Xi'an, Shaanxi, China
Zai Lab Site 01007Recruiting
Jinan, Shandong, China
Zai Lab Site 01005Recruiting
Linyi, Shandong, China
Zai Lab Site 01043Recruiting
Shanghai, Shanghai Municipality, China
Zai Lab SIte 01026Recruiting
Chengdu, Sichuan, China
Zai Lab Site 01017Recruiting
Hangzhou, Zhejiang, China
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Taizhou, Zhejiang, China
Zai Lab Site 01004Recruiting
Beijing, China
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Fukuoka, Fukuoka, Japan
Zai Lab Site 10017Recruiting
Fukuoka, Fukuoka, Japan
Zai Lab Site 10019Recruiting
Kurume, Fukuoka, Japan
Zai Lab Site 10016Recruiting
Hiroshima, Hiroshima, Japan
Zai Lab Site 10009Recruiting
Yokohama, Kanagawa, Japan
Zai Lab Site 10015Recruiting
Kashihara, Nara, Japan
Zai Lab Site 10011Recruiting
Hirakata, Osaka, Japan
Zai Lab Site 10014Recruiting
Izumi, Osaka, Japan
Zai Lab Site 10013Recruiting
Osaka, Osaka, Japan
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Sakai, Osaka, Japan
Zai Lab Site 10010Recruiting
Shizuoka, Sunto-gun, Japan
Zai Lab Site 10003Recruiting
Shimosuga, Tochigi, Japan
Zai Lab Site 10008Recruiting
Bunkyō-Ku, Tokyo, Japan
Zai Lab Site 10006Recruiting
Bunkyō-Ku, Tokyo, Japan
Zai Lab Site 10005Recruiting
Koto-Ku, Tokyo, Japan
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Shinjuku-Ku, Tokyo, Japan
Zai Lab Site 20004Recruiting
Hilversum, Netherlands
Zai Lab Site 08032Recruiting
Valencia, Valencia, Spain
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Adana, Turkey (Türkiye)
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Ankara, Turkey (Türkiye)
Zai Lab Site 14012Recruiting
Istanbul, Turkey (Türkiye)
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Istanbul, Turkey (Türkiye)
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London, Greater London, United Kingdom
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Chelsea, London, United Kingdom
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Sutton, London, United Kingdom
Zai Lab Site 21001Recruiting
Stoke-on-Trent, Staffordshire, United Kingdom