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Small-cell Lung CancerPhase 3DLLEVATENCT07218146

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

A Phase 3 study testing ZL-1310 and Investigator's Choice of Therapy in people with Small-cell Lung Cancer, run by Zai Lab (Shanghai) Co., Ltd. at 165 sites in 15 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Small-cell Lung Cancer
What is being tested?
ZL-1310 and Investigator's Choice of Therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
480 participants
Where
165 sitesin 15 countries
Study dates
30 Nov 2025to 30 Nov 2028
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 10Show fewer
  • 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

Who cannot join

  • 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.
Show all 10Show fewer
  • 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.

Trial locations and contacts

165 sites in 15 countries. Contact the study team or a site near you to ask about taking part.

ZL-1310-003 Study Team contact

650-360-1601

study-ZL-1310-003@zailaboratory.com

165 sites in 15 countries

United States37 sites, 37 recruiting

  • Cleveland Clinic - Akron General Medical Center

    Akron, Ohio, 44302

    Recruiting

  • University of Colorado

    Aurora, Colorado, 80045

    Recruiting

  • Texas Oncology - Central South

    Austin, Texas, 78745

    Recruiting

  • American Oncology Partners, PA - The Center for Cancer and Blood Disorders

    Bethesda, Maryland, 20817

    Recruiting

  • Consultants in Medical Oncology and Hematology

    Broomall, Pennsylvania, 19008

    Recruiting

  • Clermont Oncology Center

    Clermont, Florida, 34711

    Recruiting

  • University Hospitals Cleveland Medical Center

    Cleveland, Ohio, 44106

    Recruiting

  • Cleveland Clinic - Fairview Hospital Molly Pavilion

    Cleveland, Ohio, 44111

    Recruiting

  • Cleveland Clinic

    Cleveland, Ohio, 44195

    Recruiting

  • Missouri Cancer Associates

    Columbia, Missouri, 65201

    Recruiting

  • University of Texas Southwestern Medical Center/Clinical Research Department

    Dallas, Texas, 75390-9020

    Recruiting

  • Henry Ford Health Cancer

    Detroit, Michigan, 48202

    Recruiting

  • Virginia Cancer Specialists

    Fairfax, Virginia, 22031

    Recruiting

  • University of Iowa

    Iowa City, Iowa, 52242

    Recruiting

  • University of California San Diego

    La Jolla, California, 92093

    Recruiting

  • Norton Cancer Institute

    Louisville, Kentucky, 40202

    Recruiting

  • Cleveland Clinic - Hillcrest Hospital Cancer Center

    Mayfield Heights, Ohio, 44124

    Recruiting

  • Alliance Cancer Specialists

    Media, Pennsylvania, 19063

    Recruiting

  • SCRI OP (Oncology Partners)

    Nashville, Tennessee, 37203

    Recruiting

  • Yale Cancer Center/Clinical Trials Office

    New Haven, Connecticut, 06519

    Recruiting

  • Texas Oncology - West Texas

    Odessa, Texas, 79761

    Recruiting

  • Mid Florida Hematology and Oncology Center

    Orange City, Florida, 32763

    Recruiting

  • Illinois Cancer Care

    Peoria, Illinois, 61615

    Recruiting

  • OSF St. Francis Medical Center

    Peoria, Illinois, 61637

    Recruiting

  • Allegheny General Hospital

    Pittsburgh, Pennsylvania, 15212

    Recruiting

  • University of Pittsburgh (UPMC) Hillman Cancer Center

    Pittsburgh, Pennsylvania, 15232

    Recruiting

  • Cancer Centers of Bevard

    Rockledge, Florida, 32955

    Recruiting

  • UC Davis Comprehensive Cancer Center

    Sacramento, California, 95817

    Recruiting

  • Sarah Cannon Research Institute

    Sarasota, Florida, 34232

    Recruiting

  • Maryland Oncology Hematology

    Silver Spring, Maryland, 20904

    Recruiting

  • Mercy South

    St Louis, Missouri, 63128

    Recruiting

  • Florida Cancer Specialists - North

    St. Petersburg, Florida, 33701-4553

    Recruiting

  • Stony Brook Cancer Center

    Stony Brook, New York, 11794-7007

    Recruiting

  • Moffitt Cancer Center

    Tampa, Florida, 33612

    Recruiting

  • Montefiore Medical Center

    The Bronx, New York, 10461

    Recruiting

  • University of Iowa Mission Health Cancer + Blood

    Waukee, Iowa, 50263

    Recruiting

  • Florida Cancer Specialists - East

    West Palm Beach, Florida, 33401

    Recruiting

Other trials in United States

China23 sites, 23 recruiting

  • Cancer Hospital Chinese Academy of Medical Sciences

    Beijing, 000000

    Recruiting

  • Beijing Cancer Hospital

    Beijing, 100142

    Recruiting

  • Jilin Cancer Hospital

    Changchun, Jilin, 130012

    Recruiting

  • Hunan Cancer Hospital

    Changsha, Hunan, 410031

    Recruiting

  • Sichuan Cancer Hospital

    Chengdu, Sichuan, 610041

    Recruiting

  • Fujian Cancer Hospital

    Fuzhou, Fujian, 350014

    Recruiting

  • Guangdong Provincial People's Hospital

    Guangzhou, Guangdong, 510080

    Recruiting

  • Zhejiang Cancer Hospital

    Hangzhou, Zhejiang, 310000

    Recruiting

  • Anhui Provincial Hospital

    Hefei, Anhui, 230036

    Recruiting

  • Harbin Medical University Cancer Hospital

    Heilongjiang, Harbin, 000000

    Recruiting

  • Shandong Cancer Hospital

    Jinan, Shandong, 250117

    Recruiting

  • Linyi Cancer Hospital

    Linyi, Shandong, 276000

    Recruiting

  • Jiangxi Cancer Hospital

    Nanchang, Jiangxi, 330029

    Recruiting

  • Guangxi Medical University Affiliated Tumor Hospital

    Naning, Guangxi, 530021

    Recruiting

  • Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School

    Nanjing, Jiangsu

    Recruiting

  • Shanghai Pulmonary Hospital

    Shanghai, Shanghai Municipality, 200433

    Recruiting

  • Fourth Hospital of Hebei Medical University

    Shijiazhuang, Hebei

    Recruiting

  • Taizhou Hospital of Zhejiang Province

    Taizhou, Zhejiang, 318000

    Recruiting

  • Hubei Cancer Hospital

    Wuhan, Hubei, 430079

    Recruiting

  • The First Affiliated Hospital of Xi'an Jiaotong University

    Xi'an, Shaanxi, 710061

    Recruiting

  • The First Affiliated Hospital of Xiamen University

    Xiamen, Fujian, 361000

    Recruiting

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou, Henan, 450052

    Recruiting

  • Henan cancer Hospital

    Zhengzhou, 450008

    Recruiting

Other trials in China

Japan23 sites, 23 recruiting

  • Asahikawa Medical University Hospital

    Asahikawa, Hokkaido, 0788510

    Recruiting

  • Nippon Medical School Hospital

    Bunkyō-Ku, Tokyo, 113-8603

    Recruiting

  • Komagome Hospital

    Bunkyō-Ku, Tokyo, 113-8677

    Recruiting

  • Kyushu Medical Center

    Fukuoka, 810-8563

    Recruiting

  • Kyushu University Hospital

    Fukuoka, 812-8582

    Recruiting

  • Kansai Medical University Hospital

    Hirakata, Osaka, 573-1191

    Recruiting

  • Hiroshima University Hospital

    Hiroshima, 734-8551

    Recruiting

  • Izumi City General Hospital

    Izumi, Osaka, 594-0073

    Recruiting

  • Nara Medical University Hospital

    Kashihara, Nara, 634-8522

    Recruiting

  • National Cancer Center Hospital East

    Kashiwa, 277-8577

    Recruiting

  • Dokkyo Medical University Saitama Medical Center

    Koshigaya, Saitama, 343-8555

    Recruiting

  • The Cancer Institute Hospital of JFCR

    Koto-Ku, Tokyo, 135-8550

    Recruiting

  • Kurume University Hospital

    Kurume, Fukuoka, 830-0011

    Recruiting

  • Shinshu University Hospital

    Matsumoto, Nagano, 390-8621

    Recruiting

  • National Hospital Organization Nagasaki Medical Center

    Ōmura, Nagasaki, 8568562

    Recruiting

  • Osaka International Cancer Institute

    Osaka, 541-8567

    Recruiting

  • Kinki Chuo Chest Medical Center

    Sakai, Osaka, 591-8555

    Recruiting

  • KKR Sapporo Medical Center

    Sapporo, Hokkaido, 062-0931

    Recruiting

  • Sendai Kousei Hospital

    Sendai, Miyagi, 981-0914

    Recruiting

  • Dokkyo Medical University Hospital

    Shimosuga, Tochigi, 321-0293

    Recruiting

  • National Center for Global Health and Medicine

    Shinjuku-Ku, Tokyo, 162-8655

    Recruiting

  • Shizuoka Cancer Center

    Shizuoka, Sunto-gun, 411-8777

    Recruiting

  • Kanagawa Cancer Center

    Yokohama, Kanagawa, 241-8515

    Recruiting

Other trials in Japan

France14 sites, 14 recruiting

  • Institut Sainte Catherine

    Avignon, 84918

    Recruiting

  • Hospices Civils de Lyon - Hopital Louis Pradel

    Bron, 69677

    Recruiting

  • Centre Hospitalier Intercommunal de Creteil (CHIC) - Centre de ressources et de competences pour la mucoviscidose (C.R.C.M.)

    Créteil, 94010

    Recruiting

  • Centre Hospitalier - Le Mans

    Le Mans, 72037

    Recruiting

  • Centre Hospitalier Universitaire (CHU) De Limoges Hopital Dupuytren

    Limoges, 87042

    Recruiting

  • Centre Leon-Berard (CLB) - Centre de Recherche en Cancerologie Lyon-Est

    Lyon, 69008

    Recruiting

  • Centre de Recherche Clinique Hôpital de la Croix-Rousse

    Lyon, 69317

    Recruiting

  • Centre Hospitalier Regional Universitaire (CHRU) Montpellier Arnaud de Villeneuve

    Montpellier, 34295

    Recruiting

  • Centre Hospitalier Lyon-Sud, CHLS

    Pierre-Bénite, 69495

    Recruiting

  • Centre Hospitalier de Cornouaille - Hopital Laennec

    Quimper, 35033

    Recruiting

  • Hopital Nord Guillaume-et-Rene-Laennec CHU de Nantes

    Saint-Herblain, 44093

    Recruiting

  • Hopital Foch

    Suresnes, 92151

    Recruiting

  • Centre Hospitalier Intercommunal Toulon La Seyne Sur Mer (C.H.I.T.S) - Hospital Font-Pre

    Toulon, 83000

    Recruiting

  • Clinique Teissier

    Valenciennes, 59300

    Recruiting

Other trials in France

Spain14 sites, 14 recruiting

  • UOMI Cancer Center-Clinica Tres Torres

    Barcelona, 8017

    Recruiting

  • Hospital Clinic de Barcelona (Hospital Clinic i Provincial)

    Barcelona, 8036

    Recruiting

  • Hospital General Universitario de Elche

    Elche, 3203

    Recruiting

  • Institut Catala d'Oncologia GIRONA

    Girona, 17007

    Recruiting

  • Hospital Universitario de Jerez

    Jerez de la Frontera, 11404

    Recruiting

  • Hospital Universitario Ramon y Cajal

    Madrid, 28034

    Recruiting

  • Hospital Universitario La Paz

    Madrid, 28046

    Recruiting

  • Clinica Universidad de Navarra - Madrid

    Madrid, 31008

    Recruiting

  • Hospital Quironsalud Malaga

    Málaga, 29010

    Recruiting

  • Universidad de Navarra - Clínica Universidad de Navarra (CUN)

    Pamplona, 31008

    Recruiting

  • Hospital Universitari Sant Joan De Reus, S.A

    Reus, 43204

    Recruiting

  • Hospital Universitario Virgen Macarena / Clinical Research Department

    Seville, 41009

    Recruiting

  • Hospital Universitario Virgen del Rocio

    Seville, 41013

    Recruiting

  • Fundación Instituto Valenciano de Oncología

    Valencia, 46009

    Recruiting

Other trials in Spain

Turkey (Türkiye)10 sites, 10 recruiting

  • Medical Park Seyhan Hospital

    Adana, 1060

    Recruiting

  • Baskent University Adana Turgut Noyan Application and Research Center Kisla Health Campus

    Adana, 1230

    Recruiting

  • Liv Hospital Ankara

    Ankara, 6680

    Recruiting

  • Ankara Bilkent City Hospital

    Ankara, 6800

    Recruiting

  • Memorial Ankara Hospital

    Çankaya, Ankara, 6520

    Recruiting

  • Istanbul University Cerrahpasa Faculty of Medicine Hospital

    Fatih, Istanbul, 34098

    Recruiting

  • Medical Park Florya Hospital

    Istanbul, 34295

    Recruiting

  • Yeditepe University Hospital

    Istanbul, 34755

    Recruiting

  • Istanbul Medeniyet University Medical Faculty

    Kadıköy, Istanbul, 34720

    Recruiting

  • Sakarya University - Faculty of Medicine

    Sakarya, 54290

    Recruiting

Other trials in Turkey (Türkiye)

Belgium8 sites, 8 recruiting

  • Universitair Ziekenhuis Antwerpen

    Edegem, 2650

    Recruiting

  • Algemeen Ziekenhuis Sint-Lucas

    Ghent, 9000

    Recruiting

  • AZ Maria Middelares - Campus AZ Maria Middelares

    Ghent, 9000

    Recruiting

  • Jessa Ziekenhuis Salvador

    Hasselt, 3500

    Recruiting

  • Universitair Ziekenhuis Brussel

    Jette, 1090

    Recruiting

  • AZ Groeninge

    Kortrijk, 8500

    Recruiting

  • Vivalia St Joseph

    Libramont, 6800

    Recruiting

  • Universite Catholique de Louvain Namur, Centre Hospitalier Universitaire Dinant Godinne

    Yvoir, 5530

    Recruiting

Other trials in Belgium

United Kingdom7 sites, 7 recruiting

  • Addenbrooke's Hospital - Cambridge University Hospitals NHS Foundation Trust

    Cambridge, Cambridgeshire, CB2 0QQ

    Recruiting

  • Royal Marsden Hospital (RMH) - Royal Marsden NHS Foundation Trust

    Chelsea, London, SW3 6JJ

    Recruiting

  • Sarah Cannon Research Institute

    London, Greater London, W1G 6AD

    Recruiting

  • Nottingham University Hospitals NHS Trust - Nottingham City Hospital

    Nottingham, NG5 1PB

    Recruiting

  • Royal Stoke University Hospital - University Hospitals of North Midlands NHS Trust

    Stoke-on-Trent, Staffordshire, ST4 6QG

    Recruiting

  • Royal Marsden Hospital (Sutton) - Royal Marsden NHS Foundation Trus

    Sutton, London, SM2 5PT

    Recruiting

  • New Cross Hospital

    Wolverhampton, WV100QP

    Recruiting

Other trials in United Kingdom

Germany6 sites, 6 recruiting

  • Evangelische Lungenklinik Berlin

    Berlin, 10407

    Recruiting

  • Krankenhaus Koeln-Merheim

    Cologne, 51109

    Recruiting

  • University Hospital Carl Gustav Carus

    Dresden, 01307

    Recruiting

  • Klinikum der Johann Wolfgang Goethe-Universität

    Frankfurt am Main, Hesse, 60590

    Recruiting

  • Krankenhaus Martha-Maria Halle-Doelau gGmbH

    Halle, 6120

    Recruiting

  • Studiengesellschaft Haemato-Onkologie Hamburg, Prof. Laack und Partner

    Hamburg, 20251

    Recruiting

Other trials in Germany

Italy6 sites, 6 recruiting

  • Azienda Ospedaliero Universitaria Ospedali Riuniti Umberto I

    Ancona, 60126

    Recruiting

  • FPO IRCCS Candiolo

    Candiolo, 20132

    Recruiting

  • IRCCS Istituto Romagnolo per lo studio dei Tumori "Dino Amadori"(IRST)

    Meldola, 47014

    Recruiting

  • AUSL Della Romagna - Ospedale S.Maria delle Croci

    Ravenna, 48121

    Recruiting

  • Istituti Fisioterapici Ospitalieri (IFO) - Istituto Nazionale Tumori Regina Elena (IRE) UO Oncologia Ospedali Civili di Livorno

    Roma, 00144

    Recruiting

  • Centro Ricerche Cliniche di Verona s.r.l.

    Verona, 37134

    Recruiting

Other trials in Italy

Poland6 sites, 6 recruiting

  • Instytut MSF Sp. z o.o.

    Lodz, 90302

    Recruiting

  • Pratia S.A. , Pratia Poznan

    Poznan, 60-192

    Recruiting

  • Med-Polonia Sp. z o.o.

    Poznan, 60693

    Recruiting

  • Wojewodzki Szpital im. Sw. Ojca Pio w Przemyslu

    Przemyśl, 37700

    Recruiting

  • Wojskowy Instytut Medyczny,Centralny Szpital Kliniczny Ministerstwa Obronty Narodowej

    Siedlce, 08-110

    Recruiting

  • Wojskowy Instytut Medyczny

    Warsaw, 04141

    Recruiting

Other trials in Poland

Greece5 sites, 5 recruiting

  • Sotiria General Hospital of Athens

    Athens, 11527

    Recruiting

  • University General Hospital of Patras

    Rio, 26504

    Recruiting

  • NOSILEFTIKI A.E. - Saint Luke's Clinic

    Thessaloniki, 54645

    Recruiting

  • European Interbalkan Medical Center

    Thessaloniki, 55236

    Recruiting

  • Iatriko Diavalkaniko Thessalonikis

    Thessaloniki, 57001

    Recruiting

Other trials in Greece

Austria2 sites, 2 recruiting

  • Uniklinikum Salzburg, Landeskrankenhaus, Universitatsklinik fur Innere Medizin III der PMU Department of Internal Medicine III

    Salzburg, 5020

    Recruiting

  • Medizinische Universitaet Wien - Allgemeines Krankenhaus der Stadt Wien (AKH)

    Vienna, 1090

    Recruiting

Other trials in Austria

Czechia2 sites, 2 recruiting

  • Nemocnice Horovice

    Hořovice, 53002

    Recruiting

  • Nemocnice AGEL Ostrava-Vitkovice a. s.

    Vítkovice, 74101

    Recruiting

Other trials in Czechia

Netherlands2 sites, 2 recruiting

  • Amphia Ziekenhuis

    Breda, 4818 CK

    Recruiting

  • Tergooi Ziekenhuizen

    Hilversum, 1261 AN

    Recruiting

Other trials in Netherlands

About this study

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

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.

Being tested
ZL-1310, Investigator's Choice of Therapy
Medical subject headings
Small Cell Lung Carcinoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ZL-1310Drug

    ZL-1310 as a single-agent

  • Investigator's Choice of TherapyDrug

    Topotecan or Amrubicin

Study groups in NCT07218146
Study groupRoleWhat they receive
Arm 1ExperimentalZL-1310 as a single agent
Receives: Drug: ZL-1310
Arm 2Active comparatorInvestigator's Choice of Therapy
Receives: Drug: Investigator's Choice of Therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Confirmed objective response rate (ORR) assessed by Blinded Independent Central Review of ZL-1310 compared to Investigator's Choice Therapy (ICT)

    Measured: up to 30 months

  2. Overall survival of ZL-1310 compared to Investigator's Choice Therapy (ICT)

    Measured: up to 30 months

Secondary outcomes (9)

  1. Duration of response (DoR) assessed by BICR and by the investigator per RECIST v1.1 of ZL-1310 compared to Investigator's Choice Therapy (ICT)

    Measured: up to 30 months

  2. Progression-free survival (PFS) assessed by BICR and by the investigator per RECIST v1.1 of ZL-1310 compared to Investigator's Choice Therapy (ICT)

    Measured: up to 30 months

  3. Confirmed ORR assessed by the investigator per RECIST v1.1 of ZL-1310 compared to Investigator's Choice Therapy (ICT)

    Measured: up to 30 months

  4. Time to response (TTR) assessed by BICR and by the investigator per RECIST v1.1 of ZL-1310 compared to Investigator's Choice Therapy (ICT)

    Measured: up to 30 months

  5. Confirmed CNS response assessed by BICR per Response Assessment in Neuro-Oncology for Brain Metastases (RANO-BM) of ZL-1310 compared to Investigator's Choice Therapy (ICT)

    Measured: up to 30 months

  6. Occurrence of treatment-emergent adverse events (TEAEs) of ZL-1310 compared to Investigator's Choice Therapy (ICT)

    Measured: up to 30 months

  7. Changes from baseline in quality of life related parameters of ZL-1310 compared to Investigator's Choice Therapy (ICT) using EQ-5D-5L

    Measured: up to 30 months

  8. Changes from baseline in quality of life related parameters of ZL-1310 compared to Investigator's Choice Therapy (ICT) using EORTC-QLQ-C30

    Measured: up to 30 months

  9. Changes from baseline in quality of life related parameters of ZL-1310 compared to Investigator's Choice Therapy (ICT) using EORTC-QLQ-LC13

    Measured: up to 30 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Oct 2025
  2. Study start30 Nov 2025
  3. Primary completion30 Jun 2028 (estimated)
  4. Study completion30 Nov 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
480 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07218146
Sponsor's protocol ID
ZL-1310-003
Acronym
DLLEVATE
Status last verified
Oct 2026
First submitted
8 Oct 2025
Last updated
16 Oct 2026
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing ZL-1310 and Investigator's Choice of Therapy in people with Small-cell Lung Cancer, run by Zai Lab (Shanghai) Co., Ltd. at 165 sites in 15 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 16 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 165 sites in United States, China, Japan, France, Spain and 10 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact ZL-1310-003 Study Team (650-360-1601, study-ZL-1310-003@zailaboratory.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Confirmed objective response rate (ORR) assessed by Blinded Independent Central Review of ZL-1310 compared to Investigator's Choice Therapy (ICT) (time frame: up to 30 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07218146.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2026.

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