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Non-small Cell Lung CancerPhase 3NCT05668988

A Study of DZD9008 Versus Platinum-Based Doublet Chemotherapy in Local Advanced or Metastatic Non-small Cell Lung Cancer (WU-KONG28)

A Phase 3 study testing sunvozertinib and Pemetrexed+carboplatin in people with Non-small Cell Lung Cancer, run by Dizal Pharmaceuticals at 154 sites in 15 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

This is a phase 3, open-label, randomized, multi-center study assessing the efficacy and safety of DZD9008 versus platinum-based doublet chemotherapy in participants with locally advanced or metastatic NSCLC with EGFR Exon20ins mutation, who are newly diagnosed or have not received prior systemic therapy in advanced… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Non-small Cell Lung Cancer
What is being tested?
sunvozertinib and Pemetrexed+carboplatin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
324 participants
Where
154 sitesin 15 countries
Study dates
13 Dec 2022to 31 Oct 2027
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

  • Aged at least 18 years old (or per local regulatory/IRB requirement).
  • Histologically or cytologically confirmed diagnosis of non-squamous NSCLC, locally advanced (Stage IIIB and IIIC according to the 8th edition of the AJCC TNM staging criteria) or metastatic (Stage IV), not suitable for curative therapy.
  • Adequate tumor tissue available, for central laboratory confirmation of EGFR exon 20 insertion mutation
  • At least 1 measurable lesion per RECIST Version 1.1
  • Life expectancy ≥ 12 weeks
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
  • Adequate organ and hematologic function

Who cannot join

  • Prior treatment with any systemic anti-cancer therapy for locally advanced or metastatic NSCLC.
  • Spinal cord compression or leptomeningeal metastasis.
  • Concurrent EGFR mutations: exon 19 deletion, L858R, T790M, G719X, S768I, or L861Q.
  • History of stroke or intracranial hemorrhage within 6 months before randomization.
  • As judged by the investigator, any evidence of severe or uncontrolled systemic diseases, including uncontrolled hypertension and active bleeding diatheses (i.e., hemophilia and Von Willebrand disease).

Trial locations and contacts

154 sites in 15 countries.

154 sites in 15 countries

China42 sites

  • Beijing Cancer Hospital

    Beijing

  • Beijing Chest Hospital, Capital Medical University

    Beijing

  • Cancer Hospital of the Chinese Academy of Medical Sciences

    Beijing

  • Peking Union Medical College Hospital

    Beijing

  • Peking University Third Hospital

    Beijing

  • Hunan Cancer Hospital

    Changsha

  • West China Hospital of Sichuan University

    Chengdu

  • Chongqing Cancer Hospital

    Chongqing

  • Fujian Cancer Hospital

    Fuzhou

  • Fujian Medical University Union Hospital

    Fuzhou

  • The First Affiliated Hospital of Guangzhou Medical University

    Guangzhou

  • The First Affiliated Hospital of Sun Yat-sen University

    Guangzhou

  • The First Affiliated Hospital Zhejiang University School of Medicine

    Hangzhou

  • Zhejiang Cancer Hospital

    Hangzhou

  • Harbin Medical University Cancer Hospital

    Harbin

  • Anhui Provincial Hospital

    Hefei

  • The First Affiliated Hospital of Anhui Medical University

    Hefei

  • The Affiliated Hospital of Inner Mongolia Medical University

    Hohhot

  • Jilin Cancer Hospital

    Jilin City

  • Central Hospital Affiliated to Shandong First Medical University

    Jinan

  • Shandong Cancer Hospital & Institution

    Jinan

  • Yunnan Cancer Hospital

    Kunming

  • The Second Affiliated Hospital of Nanchang University

    Nanchang

  • Jiangsu Cancer Hospital

    Nanjing

  • Jiangsu Provincial Hospital

    Nanjing

  • Guangxi Medical University Cancer Hospital

    Nanning

  • Shanghai Chest Hospital

    Shanghai

  • Shanghai Pulmonary Hospital

    Shanghai

  • ZhongShan Hospital Fudan University

    Shanghai

  • The First Hospital of China Medical University

    Shenyang

  • Cancer Hospital Chinese Academy of Medical Sciences, ShenZhen center

    Shenzhen

  • The Fourth Hospital of Hebei Medical University

    Shijiazhuang

  • Shanxi Provincial Cancer Hospital

    Taiyuan

  • Taizhou Hospital of Zhejiang Province

    Taizhou

  • Tianjin Medical University Cancer Institute & Hospital

    Tianjin

  • The Affiliated Cancer Hospital of Xinjiang Medical University

    Ürümqi

  • Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science & Technology

    Wuhan

  • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

    Wuhan

  • The First Affiliated Hospital of Xi 'an Jiaotong University

    Xi'an

  • Yantai Yuhuangding Hospital

    Yantai

  • Henan Cancer Hospital

    Zhengzhou

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou

Other trials in China

Spain19 sites

  • Complejo Hospitalario Universitario A Coruña

    A Coruña

  • Institut Catala d'Oncologia Badalona (ICO Badalona) - Hospital Universitari Germans Trias i Pujol

    Barcelona, Barcelona

  • Hospital de la Santa Creu I Sant Pau

    Barcelona

  • Hospital Universitari Dexeus

    Barcelona

  • Hospital Universitari Vall d'Hebron

    Barcelona

  • UOMI Cancer Center - Clinica Mi Tres Torres

    Barcelona

  • Institut Catala d'Oncologia de Girona -Hospital Universitari Dr Josep Trueta

    Girona

  • Hospital Universitario de Jerez

    Jerez de la Frontera

  • Clínica Universidad de Navarra

    Madrid

  • Hospital HM Sanchinarro

    Madrid

  • Hospital Universitario 12 de Octubre

    Madrid

  • Hospital Universitario Fundación Jiménez Diaz

    Madrid

  • Hospital Universitario La Paz

    Madrid

  • Hospital Regional Universitario de Málaga

    Málaga

  • Hospital Universitario Virgen de Valme

    Seville

  • Hospital Universitario Virgen del Rocio

    Seville

  • Hospital Universitario Virgen Macarena

    Seville

  • Hospital Clinico Universitario de Valencia

    Valencia

  • Hospital Universitari i Politècnic La Fe

    Valencia

Other trials in Spain

France16 sites

  • Centre Hospitalier Universitaire d'Angers

    Angers

  • HCL - Hôpital Louis Pradel

    Bron

  • Centre Hospitalier Intercommunal de Creteil (CHIC)

    Créteil

  • Centre Hospitalier Universitaire (CHU) Grenobles Alpes- Hôpital Albert Michallon

    Hellemmes-Lille

  • Centre Hospitalier Universitaire Grenoble Alpes (CHU Grenoble Alpes) - Hopital Albert Michallon

    La Tronche

  • Assistance Publique Hopitaux de Marseille (AP-HM) Hopital Nord

    Marseille

  • Centre de Cancérologie du Grand Montpellier

    Montpellier

  • AP-HP - Hopital Cochin

    Paris

  • Assistance Publique-Hopitaux de Paris (AP-HP)- Hopital Tenon

    Paris

  • Hopital Paris Saint Joseph

    Paris

  • Hôpital Bichat - Claude Bernard (AP-HP)

    Paris

  • Cetre Hospitalier Universitaire de Poitiers

    Poitiers

  • CHU de Nantes - Saint Herblain

    Saint-Herblain

  • Institut de Cancerologie de L'Ouest

    Saint-Herblain

  • Hopital d'Instruction Des Armees (HIA) Begin

    Saint-Mandé

  • Hopital Foch

    Suresnes

Other trials in France

United States15 sites

  • University of Colorado Hospital - Anschutz Cancer Pavilion

    Aurora, Colorado, 80045

  • Gabrail Cancer Center Research

    Canton, Ohio, 44718

  • University of Virginia Comprehensive Cancer Center

    Charlottesville, Virginia, 22908

  • OSU Brain & Spine Hospital

    Columbus, Ohio, 43210

  • Texas Oncology - Baylor Charles A. Sammons Cancer Center

    Dallas, Texas, 75246

  • OPN Healthcare, Inc.

    Glendale, California, 91203

  • The University of Texas MD Anderson cancer center

    Houston, Texas, 77030

  • D&H Cancer Research Center LLC

    Margate, Florida, 33054

  • NYU Langone Health

    New York, New York, 10016

  • NYU Laura & Issac Perlmutter Cancer Center at NYU Langone Health

    New York, New York, 10016

  • Columbia University Medical Center

    New York, New York, 10032

  • BRCR Medical Center Inc.

    Plantation, Florida, 33324

  • Providence Portland Institute Franz

    Portland, Oregon, 97213

  • Kaiser Permanente Medical Center

    Vallejo, California, 94589

  • exas Oncology--McAllen

    Weslaco, Texas, 78596

Other trials in United States

Italy14 sites

  • Centro di Riferimento Oncologico di Aviano (CRO)-IRCCS

    Aviano

  • IRCCS Azienda Ospedaliero-Universitaria di Bologna - Policlinico Sant'Orsola

    Bologna

  • Aou Policlinico G. Rodolico - S. Marcoa

    Catania

  • Azienda Ospedaliero-Universitaria Careggi (AOUC) - SC di Oncologia MedicaI

    Florence

  • Azienda USL Toscana Sud Est -Ospedale Misericordia - Grosseto

    Grosseto

  • Istituto Scientifico Romagnolo per lo Studio e La Cura dei Tumori Srl (IRST)

    Meldola

  • Azienda Ospedaliero-Universitaria di Modena

    Modena

  • Fondazione IRCCS San Gerardo dei Tintori

    Monza

  • Casa di Cura di Alta Specialita - Palermo

    Palermo

  • Azienda Ospedaliero-Universitaria di Parma

    Parma

  • Ausl Della Romagna-Po Ravenna Lugo Faenza

    Ravenna

  • AUSL-IRCCS di Reggio Emilia

    Reggio Emilia

  • IRCCS Istituti Fisioterapici Ospitalieri- Istituto Nazionale tumori Regina Elena

    Roma

  • Azienda Ospedaliera Universitaria Senese - Ospedale Senta Maria alle

    Siena

Other trials in Italy

Brazil10 sites

  • Fundacao PIO XII - Hospital do Cancer de Barretos

    Barretos

  • Hospital Evangelico de Cachoeiro de Itapemirim

    Cachoeiro de Itapemirim

  • Liga Norte Riograndense Contra o Câncer

    Natal

  • Irmandade da Santa Casa de Misericordia de Porto Alegre

    Porto Alegre

  • Uniao Brasileira de Educacao e Assistencia - Hospital São Lucas da PUCRS

    Porto Alegre

  • Instituto D'Or de Pesquisa e Ensino

    Recife

  • Instituto D'Or de Pesquisa e Ensino

    Rio de Janeiro

  • Instituto de Educacao, Pesquisa d Gestao em Saude

    Rio de Janeiro

  • Instituto Nacional de Cancer - INCA

    Rio de Janeiro

  • Instituto do Cancer do Estado de Sao Paulo - ICESP

    São Paulo

Other trials in Brazil

Turkey (Türkiye)8 sites

  • Ankara Bilkent City Hospital

    Ankara

  • Dr. Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital

    Ankara

  • Gazi University Faculty of Medicine Hospital

    Ankara

  • Liv Hospital Ankara - Medical Oncology Clinic

    Ankara

  • Trakya University Health Research and Application Center Hospital

    Edirne

  • Bezmialem Vakif University

    Istanbul

  • Goztepe Prof. Dr. Suleyman Yalcin City Hospital

    Kadıköy

  • Necmettin Erbakan University Meram Faculty of Medicine

    Konya

Other trials in Turkey (Türkiye)

Argentina6 sites

  • Centro Medico Austral

    Buenos Aires

  • Consultorios Medicos Dr. Doreski - Fundacion Respirar

    Buenos Aires

  • Fundacion Cenit Para El Estudio De Neurociencias

    Buenos Aires

  • Instituto Argentino de Diagnositco y Tratamiento S.A

    Buenos Aires

  • Fundación Estudios Clínicos

    Rosario

  • Fundación Ars Médica

    San Salvador

Other trials in Argentina

Germany6 sites

  • Evangelische Lungenklinik Berlin

    Berlin

  • Asklepios Klinik Gauting GmbH

    Gauting

  • MVZ Ⅱ der Niels Stensen Kliniken

    Georgsmarienhütte

  • Thoraxklinik Heidelberg gGmbH

    Heidelberg

  • Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz - III. Medizinische Klinik und Poliklinik

    Mainz

  • Universitatsklinik Innere Medizin-Onkologie

    Oldenburg

Other trials in Germany

Australia4 sites

  • Concord Repatriation General Hospital

    Concord

  • Peter MacCallum Cancer Centre

    Melbourne

  • Sir Charles Gairdner Hospital

    Nedlands

  • Prince of Wales Hospital

    Randwick

Other trials in Australia

Poland4 sites

  • Klinika Onkologii i Radioterapii Uniwersyteckie Centrum Kliniczne (UCK)

    Gdansk

  • MED-POLONIA Sp. z o.o.

    Poznan

  • Wojewódzki Szpital im. św. Ojca Pio

    Przemyśl

  • Narodowy Instytut Onkologii im. M. Sklodowskiej-Curie

    Warsaw

Other trials in Poland

Belgium3 sites

  • Grand Hopital de Charleroi

    Charleroi, Hainaut

  • Universitair Ziekenhuis Antwerpen

    Edegem, Antwerp

  • UZ Gent

    Ghent, Flanders

Other trials in Belgium

Canada3 sites

  • London Regional Cancer Program London Health Sciences Centre

    London

  • The Ottawa Hospital Cancer Center

    Ottawa

  • Princess Margaret Cancer Center- University Health Network

    Toronto

Other trials in Canada

Austria2 sites

  • Ordensklinikum Linz GmbH Elisabethinen

    Linz

  • Uniklinikum Salzburg Universitatsklinik fur Innere Medizin Ⅲ

    Salzburg

Other trials in Austria

Czechia2 sites

  • Fakultni Nemocnice Olomouc

    Olomouc

  • Nemocnice AGEL Ostrava-Vitkovice a.s

    Ostrava

Other trials in Czechia

About this study

Official title: A Phase 3, Open-Label, Randomized, Multi-Center Study of DZD9008 Versus Platinum-Based Doublet Chemotherapy as First-Line Treatment for Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer Harboring Epidermal Growth Factor Receptor Exon 20 Insertion Mutation

This is a phase 3, open-label, randomized, multi-center study assessing the efficacy and safety of DZD9008 versus platinum-based doublet chemotherapy in participants with locally advanced or metastatic NSCLC with EGFR Exon20ins mutation, who are newly diagnosed or have not received prior systemic therapy in advanced stage.

Primary objective of this study is to assess the efficacy of DZD9008 versus platinum-based doublet chemotherapy using by BICR-assessed PFS per RECIST 1.1 as primary endpoint. Approximately 320 participants are estimated to be randomized into the study. Participants enrolled will be randomized to DZD9008 or platinum-based doublet chemotherapy in a 1:1 manner, stratified by baseline brain metastasis (with/without).

Being tested
sunvozertinib, Pemetrexed+carboplatin
Medical subject headings
Carcinoma, Non-Small-Cell Lung

What participants receive

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

  • sunvozertinibDrug

    orally, 300 mg, once daily until a treatment discontinuation criterion is met.

  • Pemetrexed+carboplatinDrug

    Participants randomized into chemotherapy arm can receive up to 6 cycles of pemetrexed + carboplatin (pemetrexed 500 mg/m2 + carboplatin area under the plasma concentration-time curve 5 mg/ml per minute (AUC5), IV infusion, every 3 weeks) as the initial treatment. Participants whose disease has not progressed after 4 cycles of first-line platinum-based doublet chemotherapy may receive pemetrexed maintenance monotherapy until a treatment discontinuation criterion is met.

Study groups in NCT05668988
Study groupRoleWhat they receive
sunvozertinibExperimentalNot described
Receives: Drug: sunvozertinib
Platinum-based ChemotherapyActive comparatorNot described
Receives: Drug: Pemetrexed+carboplatin

What is being measured

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

  1. Progression Free Survival (PFS) as assessed by Blinded Independent Central Review (BICR) per RECIST 1.1

    Measured: Up to approximately 34 months after the first participant is randomized

Secondary outcomes (1)

  1. Overall Survival

    Measured: Up to approximately 34 months after the first participant is randomized

Timeline

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

  1. First posted30 Dec 2022
  2. Study start13 Dec 2022
  3. Primary completion16 Jan 2026
  4. Study completion31 Oct 2027 (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
324 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05668988
Sponsor's protocol ID
DZ2022E0005
Status last verified
May 2026
First submitted
20 Dec 2022
Last updated
29 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Zhou C, Greillier L, Liu G, John T, Xing L, Kowalski D, Memmott RM, Yazici O, Sun M, Shu C, Pons-Tostivint E, Fan Y, Fernandez-Hinojal G, Shum E, Wang M, Bertolini F, Camidge DR, Zhou C, Doucet L, Hong Q, Fang J, Huang D, Jin B, Yu Y, Antonuzzo L, Moro-Sibilot D, Bennouna J, de Castro G Jr, Zheng L, Heymach JV; WU-KONG28 Investigators. First-Line Sunvozertinib in NSCLC with EGFR Exon 20 Insertion Mutations. N Engl J Med. 2026 May 29. doi: 10.1056/NEJMoa2604461. Online ahead of print.

    PubMed 42212913

  • Wang M, Fan Y, Sun M, Wang Y, Zhao Y, Jin B, Hu Y, Han Z, Song X, Liu A, Tang K, Ding C, Liang L, Wu L, Gao J, Wang J, Cheng Y, Zhou J, He Y, Dong X, Yao Y, Yu Y, Wang H, Sun S, Huang J, Fang J, Li W, Wang L, Ren X, Zhou C, Hu Y, Zhao D, Yang R, Xu F, Huang Y, Pan Y, Cui J, Xu Y, Yang Z, Shi Y. Sunvozertinib for patients in China with platinum-pretreated locally advanced or metastatic non-small-cell lung cancer and EGFR exon 20 insertion mutation (WU-KONG6): single-arm, open-label, multicentre, phase 2 trial. Lancet Respir Med. 2024 Mar;12(3):217-224. doi: 10.1016/S2213-2600(23)00379-X. Epub 2023 Dec 12.

    PubMed 38101437

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing sunvozertinib and Pemetrexed+carboplatin in people with Non-small Cell Lung Cancer, run by Dizal Pharmaceuticals at 154 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 7 inclusion and 5 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: under way, not looking for participants, as of the sponsor's last update on 29 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 154 sites in China, Spain, France, United States, Italy 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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression Free Survival (PFS) as assessed by Blinded Independent Central Review (BICR) per RECIST 1.1 (time frame: Up to approximately 34 months after the first participant is randomized). 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 NCT05668988, which also lists 2 linked publications.

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 29 Oct 2026.

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