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New hope for tough lung cancer: targeted drug ZL-1310 enters final testing

NCT ID NCT07218146

Disease control Sponsor: Zai Lab (Shanghai) Co., Ltd. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 15, 2026 · Updated 9 times

Summary

This Phase 3 trial tests ZL-1310, a drug that delivers chemotherapy directly to cancer cells, in people with small cell lung cancer that has returned after initial treatment. About 480 participants will receive either ZL-1310 or one of three standard treatments. The study aims to see if ZL-1310 shrinks tumors more effectively and helps people live longer.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
ZL-1310 (a targeted antibody-drug conjugate)
What this could lead to
If successful, ZL-1310 could offer a more effective treatment option for people with relapsed small cell lung cancer, potentially improving response rates and survival.
What could go wrong
This is an early Phase 3 trial, so results are not yet known. The drug may not work better than existing therapies, and side effects could be significant.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 480 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2025

Expected to finish

Nov 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Get notified about this study

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Conditions

The condition(s) this trial relates to.

small cell lung carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Small cell lung cancer

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    155 sites in 15 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • AUSL Della Romagna - Ospedale S.Maria delle Croci

    RECRUITING

    Ravenna, 48121, Italy

  • AZ Groeninge

    RECRUITING

    Kortrijk, 8500, Belgium

  • AZ Maria Middelares - Campus AZ Maria Middelares

    RECRUITING

    Ghent, 9000, Belgium

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

    RECRUITING

    Cambridge, Cambridgeshire, CB2 0QQ, United Kingdom

  • Algemeen Ziekenhuis Sint-Lucas

    RECRUITING

    Ghent, 9000, Belgium

  • Allegheny General Hospital

    RECRUITING

    Pittsburgh, Pennsylvania, 15212, United States

  • Alliance Cancer Specialists

    RECRUITING

    Media, Pennsylvania, 19063, United States

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

    RECRUITING

    Bethesda, Maryland, 20817, United States

  • Amphia Ziekenhuis

    RECRUITING

    Breda, 4818 CK, Netherlands

  • Anhui Provincial Hospital

    RECRUITING

    Hefei, Anhui, 230036, China

  • Ankara Bilkent City Hospital

    RECRUITING

    Ankara, Ankara, 6800, Turkey (Türkiye)

  • Asahikawa Medical University Hospital

    RECRUITING

    Asahikawa, Hokkaido, 0788510, Japan

  • Azienda Ospedaliero Universitaria Ospedali Riuniti Umberto I

    RECRUITING

    Ancona, 60126, Italy

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

    RECRUITING

    Adana, Adana, 1230, Turkey (Türkiye)

  • Beijing Cancer Hospital

    RECRUITING

    Beijing, 100142, China

  • Cancer Centers of Bevard

    RECRUITING

    Rockledge, Florida, 32955, United States

  • Cancer Hospital Chinese Academy of Medical Sciences

    RECRUITING

    Beijing, 000000, China

  • Centre Hospitalier - Le Mans

    RECRUITING

    Le Mans, 72037, France

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

    RECRUITING

    Toulon, 83000, France

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

    RECRUITING

    Créteil, 94010, France

  • Centre Hospitalier Lyon-Sud, CHLS

    RECRUITING

    Pierre-Bénite, 69495, France

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

    RECRUITING

    Montpellier, 34295, France

  • Centre Hospitalier Universitaire (CHU) De Limoges Hopital Dupuytren

    RECRUITING

    Limoges, 87042, France

  • Centre Hospitalier de Cornouaille - Hopital Laennec

    RECRUITING

    Quimper, 35033, France

  • Centre de Recherche Clinique Hôpital de la Croix-Rousse

    RECRUITING

    Lyon, 69317, France

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

    RECRUITING

    Verona, 37134, Italy

  • Clermont Oncology Center

    RECRUITING

    Clermont, Florida, 34711, United States

  • Cleveland Clinic

    RECRUITING

    Cleveland, Ohio, 44195, United States

  • Cleveland Clinic - Akron General Medical Center

    RECRUITING

    Akron, Ohio, 44302, United States

  • Cleveland Clinic - Fairview Hospital Molly Pavilion

    RECRUITING

    Cleveland, Ohio, 44111, United States

  • Cleveland Clinic - Hillcrest Hospital Cancer Center

    RECRUITING

    Mayfield Heights, Ohio, 44124, United States

  • Clinica Universidad de Navarra - Madrid

    RECRUITING

    Madrid, 31008, Spain

  • Clinique Teissier

    RECRUITING

    Valenciennes, 59300, France

  • Consultants in Medical Oncology and Hematology

    RECRUITING

    Broomall, Pennsylvania, 19008, United States

  • Dokkyo Medical University Hospital

    RECRUITING

    Shimosuga, Tochigi, 321-0293, Japan

  • Dokkyo Medical University Saitama Medical Center

    RECRUITING

    Koshigaya, Saitama, 343-8555, Japan

  • Evangelische Lungenklinik Berlin

    RECRUITING

    Berlin, 10407, Germany

  • FPO IRCCS Candiolo

    RECRUITING

    Candiolo, 20132, Italy

  • Florida Cancer Specialists - East

    RECRUITING

    West Palm Beach, Florida, 33401, United States

  • Florida Cancer Specialists - North

    RECRUITING

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

  • Fourth Hospital of Hebei Medical University

    RECRUITING

    Shijiazhuang, Hebei, China

  • Fujian Cancer Hospital

    RECRUITING

    Fuzhou, Fujian, 350014, China

  • Fundación Instituto Valenciano de Oncología

    RECRUITING

    Valencia, Valencia, 46009, Spain

  • Guangdong Provincial People's Hospital

    RECRUITING

    Guangzhou, Guangdong, 510080, China

  • Guangxi Medical University Affiliated Tumor Hospital

    RECRUITING

    Naning, Guangxi, 530021, China

  • Harbin Medical University Cancer Hospital

    RECRUITING

    Heilongjiang, Harbin, 000000, China

  • Henan cancer Hospital

    RECRUITING

    Zhengzhou, 450008, China

  • Henry Ford Health Cancer

    RECRUITING

    Detroit, Michigan, 48202, United States

  • Hiroshima University Hospital

    RECRUITING

    Hiroshima, Hiroshima, 734-8551, Japan

  • Hopital Foch

    RECRUITING

    Suresnes, 92151, France

  • Hospices Civils de Lyon - Hopital Louis Pradel

    RECRUITING

    Bron, 69677, France

  • Hospital Clinic de Barcelona (Hospital Clinic i Provincial)

    RECRUITING

    Barcelona, 8036, Spain

  • Hospital General Universitario de Elche

    RECRUITING

    Elche, 3203, Spain

  • Hospital Quironsalud Malaga

    RECRUITING

    Málaga, 29010, Spain

  • Hospital Universitari Sant Joan De Reus, S.A

    RECRUITING

    Reus, 43204, Spain

  • Hospital Universitario La Paz

    RECRUITING

    Madrid, 28046, Spain

  • Hospital Universitario Ramon y Cajal

    RECRUITING

    Madrid, 28034, Spain

  • Hospital Universitario Virgen Macarena / Clinical Research Department

    RECRUITING

    Seville, 41009, Spain

  • Hospital Universitario Virgen del Rocio

    RECRUITING

    Seville, 41013, Spain

  • Hospital Universitario de Jerez

    RECRUITING

    Jerez de la Frontera, 11404, Spain

  • Hubei Cancer Hospital

    RECRUITING

    Wuhan, Hubei, 430079, China

  • Hunan Cancer Hospital

    RECRUITING

    Changsha, Hunan, 410031, China

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

    RECRUITING

    Meldola, 47014, Italy

  • Iatriko Diavalkaniko Thessalonikis

    RECRUITING

    Thessaloniki, 57001, Greece

  • Illinois Cancer Care

    RECRUITING

    Peoria, Illinois, 61615, United States

  • Institut Catala d'Oncologia GIRONA

    RECRUITING

    Girona, 17007, Spain

  • Institut Sainte Catherine

    RECRUITING

    Avignon, 84918, France

  • Instytut MSF Sp. z o.o.

    RECRUITING

    Lodz, 90302, Poland

  • Istanbul Medeniyet University Medical Faculty

    RECRUITING

    Kadıköy, Istanbul, 34720, Turkey (Türkiye)

  • Istanbul University Cerrahpasa Faculty of Medicine Hospital

    RECRUITING

    Fatih, Istanbul, 34098, Turkey (Türkiye)

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

    RECRUITING

    Roma, 00144, Italy

  • Izumi City General Hospital

    RECRUITING

    Izumi, Osaka, 594-0073, Japan

  • Jessa Ziekenhuis Salvador

    RECRUITING

    Hasselt, 3500, Belgium

  • Jiangxi Cancer Hospital

    RECRUITING

    Nanchang, Jiangxi, 330029, China

  • Jilin Cancer Hospital

    RECRUITING

    Changchun, Jilin, 130012, China

  • KKR Sapporo Medical Center

    RECRUITING

    Sapporo, Hokkaido, 062-0931, Japan

  • Kanagawa Cancer Center

    RECRUITING

    Yokohama, Kanagawa, 241-8515, Japan

  • Kansai Medical University Hospital

    RECRUITING

    Hirakata, Osaka, 573-1191, Japan

  • Kinki Chuo Chest Medical Center

    RECRUITING

    Sakai, Osaka, 591-8555, Japan

  • Klinikum der Johann Wolfgang Goethe-Universität

    RECRUITING

    Frankfurt am Main, Hesse, 60590, Germany

  • Komagome Hospital

    RECRUITING

    Bunkyō-Ku, Tokyo, 113-8677, Japan

  • Krankenhaus Martha-Maria Halle-Doelau gGmbH

    RECRUITING

    Halle, 6120, Germany

  • Kurume University Hospital

    RECRUITING

    Kurume, Fukuoka, 830-0011, Japan

  • Kyushu Medical Center

    RECRUITING

    Fukuoka, Fukuoka, 810-8563, Japan

  • Kyushu University Hospital

    RECRUITING

    Fukuoka, Fukuoka, 812-8582, Japan

  • Linyi Cancer Hospital

    RECRUITING

    Linyi, Shandong, 276000, China

  • Liv Hospital Ankara

    RECRUITING

    Ankara, 6680, Turkey (Türkiye)

  • Maryland Oncology Hematology

    RECRUITING

    Silver Spring, Maryland, 20904, United States

  • Med-Polonia Sp. z o.o.

    RECRUITING

    Poznan, 60693, Poland

  • Medical Park Florya Hospital

    RECRUITING

    Istanbul, 34295, Turkey (Türkiye)

  • Medical Park Seyhan Hospital

    RECRUITING

    Adana, 1060, Turkey (Türkiye)

  • Memorial Ankara Hospital

    RECRUITING

    Çankaya, Ankara, 6520, Turkey (Türkiye)

  • Mercy South

    RECRUITING

    St Louis, Missouri, 63128, United States

  • Mid Florida Hematology and Oncology Center

    RECRUITING

    Orange City, Florida, 32763, United States

  • Missouri Cancer Associates

    RECRUITING

    Columbia, Missouri, 65201, United States

  • Moffitt Cancer Center

    RECRUITING

    Tampa, Florida, 33612, United States

  • Montefiore Medical Center

    RECRUITING

    The Bronx, New York, 10461, United States

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

    RECRUITING

    Nanjing, Jiangsu, China

  • Nara Medical University Hospital

    RECRUITING

    Kashihara, Nara, 634-8522, Japan

  • National Center for Global Health and Medicine

    RECRUITING

    Shinjuku-Ku, Tokyo, 162-8655, Japan

  • National Hospital Organization Nagasaki Medical Center

    RECRUITING

    Ōmura, Nagasaki, 8568562, Japan

  • Nemocnice AGEL Ostrava-Vitkovice a. s.

    RECRUITING

    Vítkovice, 74101, Czechia

  • Nemocnice Horovice

    RECRUITING

    Hořovice, 53002, Czechia

  • New Cross Hospital

    RECRUITING

    Wolverhampton, WV100QP, United Kingdom

  • Nippon Medical School Hospital

    RECRUITING

    Bunkyō-Ku, Tokyo, 113-8603, Japan

  • Norton Cancer Institute

    RECRUITING

    Louisville, Kentucky, 40202, United States

  • Nottingham University Hospitals NHS Trust - Nottingham City Hospital

    RECRUITING

    Nottingham, NG5 1PB, United Kingdom

  • OSF St. Francis Medical Center

    RECRUITING

    Peoria, Illinois, 61637, United States

  • Osaka International Cancer Institute

    RECRUITING

    Osaka, Osaka, 541-8567, Japan

  • Pratia S.A. , Pratia Poznan

    RECRUITING

    Poznan, 60-192, Poland

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

    RECRUITING

    Chelsea, London, SW3 6JJ, United Kingdom

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

    RECRUITING

    Sutton, London, SM2 5PT, United Kingdom

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

    RECRUITING

    Stoke-on-Trent, Staffordshire, ST4 6QG, United Kingdom

  • SCRI OP (Oncology Partners)

    RECRUITING

    Nashville, Tennessee, 37203, United States

  • Sakarya University - Faculty of Medicine

    RECRUITING

    Adapazarı, Sakarya, 54290, Turkey (Türkiye)

  • Sarah Cannon Research Institute

    RECRUITING

    Sarasota, Florida, 34232, United States

  • Sarah Cannon Research Institute

    RECRUITING

    London, Greater London, W1G 6AD, United Kingdom

  • Sendai Kousei Hospital

    RECRUITING

    Sendai, Miyagi, 981-0914, Japan

  • Shandong Cancer Hospital

    RECRUITING

    Jinan, Shandong, 250117, China

  • Shanghai Pulmonary Hospital

    RECRUITING

    Shanghai, Shanghai Municipality, 200433, China

  • Shinshu University Hospital

    RECRUITING

    Matsumoto, Nagano, 390-8621, Japan

  • Shizuoka Cancer Center

    RECRUITING

    Shizuoka, Sunto-gun, 411-8777, Japan

  • Sichuan Cancer Hospital

    RECRUITING

    Chengdu, Sichuan, 610041, China

  • Stony Brook Cancer Center

    RECRUITING

    Stony Brook, New York, 11794-7007, United States

  • Taizhou Hospital of Zhejiang Province

    RECRUITING

    Taizhou, Zhejiang, 318000, China

  • Tergooi Ziekenhuizen

    RECRUITING

    Hilversum, 1261 AN, Netherlands

  • Texas Oncology - Central South

    RECRUITING

    Austin, Texas, 78745, United States

  • Texas Oncology - West Texas

    RECRUITING

    Odessa, Texas, 79761, United States

  • The Cancer Institute Hospital of JFCR

    RECRUITING

    Koto-Ku, Tokyo, 135-8550, Japan

  • The First Affiliated Hospital of Xi'an Jiaotong University

    RECRUITING

    Xi'an, Shaanxi, 710061, China

  • The First Affiliated Hospital of Xiamen University

    RECRUITING

    Xiamen, Fujian, 361000, China

  • The First Affiliated Hospital of Zhengzhou University

    RECRUITING

    Zhengzhou, Henan, 450052, China

  • UC Davis Comprehensive Cancer Center

    RECRUITING

    Sacramento, California, 95817, United States

  • UOMI Cancer Center-Clinica Tres Torres

    RECRUITING

    Barcelona, 8017, Spain

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

    RECRUITING

    Salzburg, 5020, Austria

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

    RECRUITING

    Pamplona, 31008, Spain

  • Universitair Ziekenhuis Antwerpen

    RECRUITING

    Edegem, 2650, Belgium

  • Universitair Ziekenhuis Brussel

    RECRUITING

    Jette, 1090, Belgium

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

    RECRUITING

    Yvoir, 5530, Belgium

  • University Hospital Carl Gustav Carus

    RECRUITING

    Dresden, 01307, Germany

  • University Hospitals Cleveland Medical Center

    RECRUITING

    Cleveland, Ohio, 44106, United States

  • University of California San Diego

    RECRUITING

    La Jolla, California, 92093, United States

  • University of Colorado

    RECRUITING

    Aurora, Colorado, 80045, United States

  • University of Iowa

    RECRUITING

    Iowa City, Iowa, 52242, United States

  • University of Iowa Mission Health Cancer + Blood

    RECRUITING

    Waukee, Iowa, 50263, United States

  • University of Pittsburgh (UPMC) Hillman Cancer Center

    RECRUITING

    Pittsburgh, Pennsylvania, 15232, United States

  • University of Texas Southwestern Medical Center/Clinical Research Department

    RECRUITING

    Dallas, Texas, 75390-9020, United States

  • Virginia Cancer Specialists

    RECRUITING

    Fairfax, Virginia, 22031, United States

  • Vivalia St Joseph

    RECRUITING

    Libramont, 6800, Belgium

  • Wojewodzki Szpital im. Sw. Ojca Pio w Przemyslu

    RECRUITING

    Przemyśl, 37700, Poland

  • Wojskowy Instytut Medyczny

    RECRUITING

    Warsaw, 04141, Poland

  • Wojskowy Instytut Medyczny,Centralny Szpital Kliniczny Ministerstwa Obronty Narodowej

    RECRUITING

    Siedlce, 08-110, Poland

  • Yale Cancer Center/Clinical Trials Office

    RECRUITING

    New Haven, Connecticut, 06519, United States

  • Yeditepe University Hospital

    RECRUITING

    Istanbul, 34755, Turkey (Türkiye)

  • Zhejiang Cancer Hospital

    RECRUITING

    Hangzhou, Zhejiang, 310000, China

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