A Study of DZD9008 Versus Platinum-Based Doublet Chemotherapy in Local Advanced or Metastatic Non-small Cell Lung Cancer (WU-KONG28)
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
1 other identifier
interventional
324
15 countries
156
Brief 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 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3 nonsmall-cell-lung-cancer
Started Dec 2022
156 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 13, 2022
CompletedFirst Submitted
Initial submission to the registry
December 20, 2022
CompletedFirst Posted
Study publicly available on registry
December 30, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 16, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
October 31, 2027
ExpectedFebruary 17, 2026
February 1, 2026
3.1 years
December 20, 2022
February 12, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Progression Free Survival (PFS) as assessed by Blinded Independent Central Review (BICR) per RECIST 1.1
Up to approximately 34 months after the first participant is randomized
Secondary Outcomes (1)
Overall Survival
Up to approximately 34 months after the first participant is randomized
Study Arms (2)
sunvozertinib
EXPERIMENTALPlatinum-based Chemotherapy
ACTIVE COMPARATORInterventions
orally, 300 mg, once daily until a treatment discontinuation criterion is met.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (160)
OPN Healthcare, Inc.
Glendale, California, 91203, United States
Kaiser Permanente Medical Center
Vallejo, California, 94589, United States
University of Colorado Hospital - Anschutz Cancer Pavilion
Aurora, Colorado, 80045, United States
D&H Cancer Research Center LLC
Margate, Florida, 33054, United States
BRCR Medical Center Inc.
Plantation, Florida, 33324, United States
H. Lee Moffitt Cancer Center
Tampa, Florida, 33612, United States
NYU Laura & Issac Perlmutter Cancer Center at NYU Langone Health
New York, New York, 10016, United States
Columbia University Medical Center
New York, New York, 10032, United States
Gabrail Cancer Center Research
Canton, Ohio, 44718, United States
OSU Brain & Spine Hospital
Columbus, Ohio, 43210, United States
Providence Portland Institute Franz
Portland, Oregon, 97213, United States
Texas Oncology - Baylor Charles A. Sammons Cancer Center
Dallas, Texas, 75246, United States
The University of Texas MD Anderson cancer center
Houston, Texas, 77030, United States
exas Oncology--McAllen
Weslaco, Texas, 78596, United States
University of Virginia Comprehensive Cancer Center
Charlottesville, Virginia, 22908, United States
Centro de Educación Médica e Investigaciones Clínicas, CEMIC
Buenos Aires, Argentina
Centro Diabaid
Buenos Aires, Argentina
Centro Medico Austral
Buenos Aires, Argentina
Consultorios Medicos Dr. Doreski - Fundacion Respirar
Buenos Aires, Argentina
Fundacion Cenit Para El Estudio De Neurociencias
Buenos Aires, Argentina
Hospital Italiano de Buenos Aires (HIBA)
Buenos Aires, Argentina
Instituto Alexander Fleming
Buenos Aires, Argentina
Instituto Argentino de Diagnositco y Tratamiento S.A
Buenos Aires, Argentina
Fundación Estudios Clínicos
Rosario, Argentina
Fundación Ars Médica
San Salvador, Argentina
Centro de Investigación Clínicas. Clinica Viedma S.A
Viedma, Argentina
Concord Repatriation General Hospital
Concord, Australia
Peter MacCallum Cancer Centre
Melbourne, Australia
Sir Charles Gairdner Hospital
Nedlands, Australia
Prince of Wales Hospital
Randwick, Australia
Ordensklinikum Linz GmbH Elisabethinen
Linz, Austria
Uniklinikum Salzburg Universitatsklinik fur Innere Medizin Ⅲ
Salzburg, Austria
Universitair Ziekenhuis Antwerpen
Edegem, Antwerp, Belgium
UZ Gent
Ghent, Flanders, Belgium
Grand Hopital de Charleroi
Charleroi, Hainaut, Belgium
Fundacao PIO XII - Hospital do Cancer de Barretos
Barretos, Brazil
Hospital Evangelico de Cachoeiro de Itapemirim
Cachoeiro de Itapemirim, Brazil
Liga Norte Riograndense Contra o Câncer
Natal, Brazil
Irmandade da Santa Casa de Misericordia de Porto Alegre
Porto Alegre, Brazil
Uniao Brasileira de Educacao e Assistencia - Hospital São Lucas da PUCRS
Porto Alegre, Brazil
Instituto D'Or de Pesquisa e Ensino
Recife, Brazil
Instituto D'Or de Pesquisa e Ensino
Rio de Janeiro, Brazil
Instituto de Educacao, Pesquisa d Gestao em Saude
Rio de Janeiro, Brazil
Instituto Nacional de Cancer - INCA
Rio de Janeiro, Brazil
Instituto do Cancer do Estado de Sao Paulo - ICESP
São Paulo, Brazil
London Regional Cancer Program London Health Sciences Centre
London, Canada
The Ottawa Hospital Cancer Center
Ottawa, Canada
Princess Margaret Cancer Center- University Health Network
Toronto, Canada
Beijing Cancer Hospital
Beijing, China
Beijing Chest Hospital, Capital Medical University
Beijing, China
Cancer Hospital of the Chinese Academy of Medical Sciences
Beijing, China
Peking Union Medical College Hospital
Beijing, China
Peking University Third Hospital
Beijing, China
Hunan Cancer Hospital
Changsha, China
West China Hospital of Sichuan University
Chengdu, China
Army Medical Center of PLA
Chongqing, China
Chongqing Cancer Hospital
Chongqing, China
Fujian Cancer Hospital
Fuzhou, China
Fujian Medical University Union Hospital
Fuzhou, China
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, China
The First Affiliated Hospital of Sun Yat-sen University
Guangzhou, China
The First Affiliated Hospital Zhejiang University School of Medicine
Hangzhou, China
Zhejiang Cancer Hospital
Hangzhou, China
Harbin Medical University Cancer Hospital
Harbin, China
Anhui Provincial Hospital
Hefei, China
The First Affiliated Hospital of Anhui Medical University
Hefei, China
The Affiliated Hospital of Inner Mongolia Medical University
Hohhot, China
Jilin Cancer Hospital
Jilin, China
Central Hospital Affiliated to Shandong First Medical University
Jinan, China
Shandong Cancer Hospital & Institution
Jinan, China
Yunnan Cancer Hospital
Kunming, China
The Second Affiliated Hospital of Nanchang University
Nanchang, China
Jiangsu Cancer Hospital
Nanjing, China
Jiangsu Provincial Hospital
Nanjing, China
Guangxi Medical University Cancer Hospital
Nanning, China
Shanghai Chest Hospital
Shanghai, China
Shanghai Pulmonary Hospital
Shanghai, China
ZhongShan Hospital Fudan University
Shanghai, China
The First Hospital of China Medical University
Shenyang, China
Cancer Hospital Chinese Academy of Medical Sciences, ShenZhen center
Shenzhen, China
The Fourth Hospital of Hebei Medical University
Shijiazhuang, China
Shanxi Provincial Cancer Hospital
Taiyuan, China
Taizhou Hospital of Zhejiang Province
Taizhou, China
Tianjin Medical University Cancer Institute & Hospital
Tianjin, China
Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science & Technology
Wuhan, China
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, China
The First Affiliated Hospital of Xi 'an Jiaotong University
Xi'an, China
Yantai Yuhuangding Hospital
Yantai, China
Henan Cancer Hospital
Zhengzhou, China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, China
Fakultni Nemocnice Olomouc
Olomouc, Czechia
Nemocnice AGEL Ostrava-Vitkovice a.s
Ostrava, Czechia
Centre Hospitalier Universitaire d'Angers
Angers, France
HCL - Hôpital Louis Pradel
Bron, France
Centre Hospitalier Intercommunal de Creteil (CHIC)
Créteil, France
Centre Hospitalier Universitaire (CHU) Grenobles Alpes- Hôpital Albert Michallon
Hellemmes-Lille, France
Centre Hospitalier Universitaire Grenoble Alpes (CHU Grenoble Alpes) - Hopital Albert Michallon
La Tronche, France
Assistance Publique Hopitaux de Marseille (AP-HM) Hopital Nord
Marseille, France
Centre de Cancérologie du Grand Montpellier
Montpellier, France
AP-HP - Hopital Cochin
Paris, France
Assistance Publique-Hopitaux de Paris (AP-HP)- Hopital Tenon
Paris, France
Hopital Paris Saint Joseph
Paris, France
Hôpital Bichat - Claude Bernard (AP-HP)
Paris, France
Cetre Hospitalier Universitaire de Poitiers
Poitiers, France
CHU de Nantes - Saint Herblain
Saint-Herblain, France
Institut de Cancerologie de L'Ouest
Saint-Herblain, France
Hopital d'Instruction Des Armees (HIA) Begin
Saint-Mandé, France
Hopital Foch
Suresnes, France
Evangelische Lungenklinik Berlin
Berlin, Germany
Asklepios Klinik Gauting GmbH
Gauting, Germany
MVZ Ⅱ der Niels Stensen Kliniken
Georgsmarienhütte, Germany
Thoraxklinik Heidelberg gGmbH
Heidelberg, Germany
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz - III. Medizinische Klinik und Poliklinik
Mainz, Germany
Universitatsklinik Innere Medizin-Onkologie
Oldenburg, Germany
Centro di Riferimento Oncologico di Aviano (CRO)-IRCCS
Aviano, Italy
IRCCS Azienda Ospedaliero-Universitaria di Bologna - Policlinico Sant'Orsola
Bologna, Italy
Aou Policlinico G. Rodolico - S. Marcoa
Catania, Italy
Azienda Ospedaliero-Universitaria Careggi (AOUC) - SC di Oncologia MedicaI
Florence, Italy
Azienda USL Toscana Sud Est -Ospedale Misericordia - Grosseto
Grosseto, Italy
Istituto Scientifico Romagnolo per lo Studio e La Cura dei Tumori Srl (IRST)
Meldola, Italy
Azienda Ospedaliero-Universitaria di Modena
Modena, Italy
Fondazione IRCCS San Gerardo dei Tintori
Monza, Italy
Casa di Cura di Alta Specialita - Palermo
Palermo, Italy
Azienda Ospedaliero-Universitaria di Parma
Parma, Italy
Ausl Della Romagna-Po Ravenna Lugo Faenza
Ravenna, Italy
AUSL-IRCCS di Reggio Emilia
Reggio Emilia, Italy
IRCCS Istituti Fisioterapici Ospitalieri- Istituto Nazionale tumori Regina Elena
Roma, Italy
Azienda Ospedaliera Universitaria Senese - Ospedale Senta Maria alle
Siena, Italy
Universiteit Maastricht (UM) - Maastricht University Medical Centre (Maastricht UMC+)
Maastricht, Netherlands
Klinika Onkologii i Radioterapii Uniwersyteckie Centrum Kliniczne (UCK)
Gdansk, Poland
MED-POLONIA Sp. z o.o.
Poznan, Poland
Wojewódzki Szpital im. św. Ojca Pio
Przemyśl, Poland
Narodowy Instytut Onkologii im. M. Sklodowskiej-Curie
Warsaw, Poland
Institut Catala d'Oncologia Badalona (ICO Badalona) - Hospital Universitari Germans Trias i Pujol
Barcelona, Barcelona, Spain
Complejo Hospitalario Universitario A Coruña
A Coruña, Spain
Hospital de la Santa Creu I Sant Pau
Barcelona, Spain
Hospital Universitari Dexeus
Barcelona, Spain
Hospital Universitari Vall d'Hebron
Barcelona, Spain
UOMI Cancer Center - Clinica Mi Tres Torres
Barcelona, Spain
Institut Catala d'Oncologia de Girona -Hospital Universitari Dr Josep Trueta
Girona, Spain
Hospital Universitario de Jerez
Jerez de la Frontera, Spain
Clínica Universidad de Navarra
Madrid, Spain
Hospital HM Sanchinarro
Madrid, Spain
Hospital Universitario 12 de Octubre
Madrid, Spain
Hospital Universitario Fundación Jiménez Diaz
Madrid, Spain
Hospital Universitario La Paz
Madrid, Spain
Hospital Regional Universitario de Málaga
Málaga, Spain
Hospital Universitario Virgen de Valme
Seville, Spain
Hospital Universitario Virgen del Rocio
Seville, Spain
Hospital Universitario Virgen Macarena
Seville, Spain
Hospital Clinico Universitario de Valencia
Valencia, Spain
Hospital Universitari i Politècnic La Fe
Valencia, Spain
Ankara Bilkent City Hospital
Ankara, Turkey (Türkiye)
Dr. Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital
Ankara, Turkey (Türkiye)
Gazi University Faculty of Medicine Hospital
Ankara, Turkey (Türkiye)
Liv Hospital Ankara - Medical Oncology Clinic
Ankara, Turkey (Türkiye)
Trakya University Health Research and Application Center Hospital
Edirne, Turkey (Türkiye)
Bezmialem Vakif University
Istanbul, Turkey (Türkiye)
Goztepe Prof. Dr. Suleyman Yalcin City Hospital
Kadıköy, Turkey (Türkiye)
Necmettin Erbakan University Meram Faculty of Medicine
Konya, Turkey (Türkiye)
Related Publications (1)
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.
PMID: 38101437DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Caicun Zhou
Shanghai Pulmonary Hospital, Shanghai, China
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 20, 2022
First Posted
December 30, 2022
Study Start
December 13, 2022
Primary Completion
January 16, 2026
Study Completion (Estimated)
October 31, 2027
Last Updated
February 17, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will not share