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

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).

Study Overview

• Status: Active, not recruiting
• Conditions: Non-small Cell Lung Cancer
• Intervention / Treatment: Drug: Pemetrexed+carboplatin; Drug: sunvozertinib

• Study Type: Interventional
• Enrollment (Actual): 324
• Phase: Phase 3

Contacts and Locations

Study Locations

• Argentina
  • Buenos Aires, Argentina
    • Instituto Alexander Fleming
  • Buenos Aires, Argentina
    • 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 Argentino de Diagnositco y Tratamiento S.A
  • Rosario, Argentina
    • Fundacion Estudios Clinicos
  • San Salvador, Argentina
    • Fundacion Ars Medica
  • Viedma, Argentina
    • Centro de Investigación Clínicas. Clinica Viedma S.A
• Australia
  • Concord, Australia
    • Concord Repatriation General Hospital
  • Melbourne, Australia
    • Peter MacCallum Cancer Centre
  • Nedlands, Australia
    • Sir Charles Gairdner Hospital
  • Randwick, Australia
    • Prince of Wales Hospital
• Austria
  • Linz, Austria
    • Ordensklinikum Linz GmbH Elisabethinen
  • Salzburg, Austria
    • Uniklinikum Salzburg Universitatsklinik fur Innere Medizin Ⅲ
• Belgium
  • Antwerp
    • Edegem, Antwerp, Belgium
      • Universitair Ziekenhuis Antwerpen
  • Flanders
    • Ghent, Flanders, Belgium
      • UZ Gent
  • Hainaut
    • Charleroi, Hainaut, Belgium
      • Grand Hôpital de Charleroi
• Brazil
  • Barretos, Brazil
    • Fundacao PIO XII - Hospital do Cancer de Barretos
  • Cachoeiro de Itapemirim, Brazil
    • Hospital Evangelico de Cachoeiro de Itapemirim
  • Natal, Brazil
    • Liga Norte Riograndense Contra O Cancer
  • Porto Alegre, Brazil
    • Irmandade da Santa Casa de Misericordia de Porto Alegre
  • Porto Alegre, Brazil
    • Uniao Brasileira de Educacao e Assistencia - Hospital São Lucas da PUCRS
  • Recife, Brazil
    • Instituto D'Or de Pesquisa e Ensino
  • Rio de Janeiro, Brazil
    • Instituto Nacional de Cancer - INCa
  • Rio de Janeiro, Brazil
    • Instituto D'Or de Pesquisa e Ensino
  • Rio de Janeiro, Brazil
    • Instituto de Educacao, Pesquisa d Gestao em Saude
  • São Paulo, Brazil
    • Instituto do Cancer do Estado de Sao Paulo - ICESP
• Canada
  • London, Canada
    • London Regional Cancer Program London Health Sciences Centre
  • Ottawa, Canada
    • The Ottawa Hospital Cancer Center
  • Toronto, Canada
    • Princess Margaret Cancer Center- University Health Network
• China
  • Beijing, China
    • Peking University Third Hospital
  • Beijing, China
    • Beijing Cancer Hospital
  • Beijing, China
    • Peking Union Medical College Hospital
  • Beijing, China
    • Beijing Chest Hospital, Capital Medical University
  • Beijing, China
    • Cancer Hospital of the Chinese Academy of Medical Sciences
  • Changsha, China
    • Hunan Cancer Hospital
  • Chengdu, China
    • West China Hospital of Sichuan University
  • Chongqing, China
    • Chongqing Cancer Hospital
  • Fuzhou, China
    • Fujian Medical University Union Hospital
  • Fuzhou, China
    • Fujian Cancer Hospital
  • Guangzhou, China
    • The First Affiliated Hospital of Sun Yat-Sen University
  • Guangzhou, China
    • The First Affiliated Hospital of Guangzhou Medical University
  • Hangzhou, China
    • Zhejiang Cancer Hospital
  • Hangzhou, China
    • The First Affiliated Hospital Zhejiang University School of Medicine
  • Harbin, China
    • Harbin medical university cancer hospital
  • Hefei, China
    • The First Affiliated Hospital of Anhui Medical University
  • Hefei, China
    • Anhui Provincial Hospital
  • Hohhot, China
    • The Affiliated Hospital of Inner Mongolia Medical University
  • Jilin, China
    • Jilin Cancer Hospital
  • Jinan, China
    • Central Hospital Affiliated to Shandong First Medical University
  • Jinan, China
    • Shandong Cancer Hospital & Institution
  • Kunming, China
    • Yunnan Cancer Hospital
  • Nanchang, China
    • The Second Affiliated Hospital of Nanchang University
  • Nanjing, China
    • Jiangsu Cancer Hospital
  • Nanjing, China
    • Jiangsu Provincial Hospital
  • Nanning, China
    • Guangxi Medical University Cancer Hospital
  • Shanghai, China
    • Shanghai Pulmonary Hospital
  • Shanghai, China
    • Shanghai Chest Hospital
  • Shanghai, China
    • Zhongshan Hospital Fudan University
  • Shenyang, China
    • The First Hospital of China Medical University
  • Shenzhen, China
    • Cancer Hospital Chinese Academy of Medical Sciences, ShenZhen center
  • Shijiazhuang, China
    • The Fourth Hospital of Hebei Medical University
  • Taiyuan, China
    • Shanxi Provincial Cancer hospital
  • Taizhou, China
    • Taizhou Hospital of Zhejiang Province
  • Tianjin, China
    • Tianjin Medical University Cancer Institute & Hospital
  • Wuhan, China
    • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
  • Wuhan, China
    • Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science & Technology
  • Xi'an, China
    • The First Affiliated Hospital of Xi 'an Jiaotong University
  • Yantai, China
    • Yantai Yuhuangding Hospital
  • Zhengzhou, China
    • Henan Cancer Hospital
  • Zhengzhou, China
    • The first affiliated hospital of Zhengzhou university
  • Xinjiang
    • Ürümqi, Xinjiang, China
      • The Affiliated Cancer Hospital of Xinjiang Medical University
• Czechia
  • Olomouc, Czechia
    • Fakultni nemocnice Olomouc
  • Ostrava, Czechia
    • Nemocnice AGEL Ostrava-Vitkovice a.s
• France
  • Angers, France
    • Centre Hospitalier Universitaire d'Angers
  • Bron, France
    • HCL - Hôpital Louis Pradel
  • Créteil, France
    • Centre Hospitalier Intercommunal de Creteil (CHIC)
  • Hellemmes-Lille, France
    • Centre Hospitalier Universitaire (CHU) Grenobles Alpes- Hôpital Albert Michallon
  • La Tronche, France
    • Centre Hospitalier Universitaire Grenoble Alpes (CHU Grenoble Alpes) - Hopital Albert Michallon
  • Marseille, France
    • Assistance Publique Hopitaux de Marseille (AP-HM) Hopital Nord
  • Montpellier, France
    • Centre de Cancerologie du Grand Montpellier
  • Paris, France
    • Hôpital Paris Saint Joseph
  • Paris, France
    • AP-HP - Hopital Cochin
  • Paris, France
    • Assistance Publique-Hopitaux de Paris (AP-HP)- Hopital Tenon
  • Paris, France
    • Hôpital Bichat - Claude Bernard (AP-HP)
  • Poitiers, France
    • Cetre Hospitalier Universitaire de Poitiers
  • Saint-Herblain, France
    • Institut de cancerologie de l'ouest
  • Saint-Herblain, France
    • CHU de Nantes - Saint Herblain
  • Saint-Mandé, France
    • Hopital d'Instruction Des Armees (HIA) Begin
  • Suresnes, France
    • Hopital Foch
• Germany
  • Berlin, Germany
    • Evangelische Lungenklinik Berlin
  • Gauting, Germany
    • Asklepios Klinik Gauting GmbH
  • Georgsmarienhütte, Germany
    • MVZ Ⅱ der Niels Stensen Kliniken
  • Heidelberg, Germany
    • Thoraxklinik Heidelberg gGmbH
  • Mainz, Germany
    • Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz - III. Medizinische Klinik und Poliklinik
  • Oldenburg, Germany
    • Universitatsklinik Innere Medizin-Onkologie
• Italy
  • Aviano, Italy
    • Centro di Riferimento Oncologico di Aviano (CRO)-IRCCS
  • Bologna, Italy
    • IRCCS Azienda Ospedaliero-Universitaria di Bologna - Policlinico Sant'Orsola
  • Catania, Italy
    • Aou Policlinico G. Rodolico - S. Marcoa
  • Florence, Italy
    • Azienda Ospedaliero-Universitaria Careggi (AOUC) - SC di Oncologia MedicaI
  • Grosseto, Italy
    • Azienda USL Toscana Sud Est -Ospedale Misericordia - Grosseto
  • Meldola, Italy
    • Istituto Scientifico Romagnolo per lo Studio e La Cura dei Tumori Srl (IRST)
  • Modena, Italy
    • Azienda Ospedaliero-Universitaria di Modena
  • Monza, Italy
    • Fondazione IRCCS San Gerardo dei Tintori
  • Palermo, Italy
    • Casa di Cura di Alta Specialita - Palermo
  • Parma, Italy
    • Azienda Ospedaliero-Universitaria Di Parma
  • Ravenna, Italy
    • Ausl Della Romagna-Po Ravenna Lugo Faenza
  • Reggio Emilia, Italy
    • AUSL-IRCCS di Reggio Emilia
  • Roma, Italy
    • IRCCS Istituti Fisioterapici Ospitalieri- Istituto Nazionale tumori Regina Elena
  • Siena, Italy
    • Azienda Ospedaliera Universitaria Senese - Ospedale Senta Maria alle
• Poland
  • Gdansk, Poland
    • Klinika Onkologii i Radioterapii Uniwersyteckie Centrum Kliniczne (UCK)
  • Poznan, Poland
    • Med-Polonia Sp. z o.o.
  • Przemyśl, Poland
    • Wojewódzki Szpital im. św. Ojca Pio
  • Warsaw, Poland
    • Narodowy Instytut Onkologii im. M. Sklodowskiej-Curie
• Spain
  • A Coruña, Spain
    • Complejo Hospitalario Universitario A Coruña
  • Barcelona, Spain
    • Hospital Universitari Vall d'Hebron
  • Barcelona, Spain
    • Hospital de la Santa Creu i Sant Pau
  • Barcelona, Spain
    • Hospital Universitari Dexeus
  • Barcelona, Spain
    • UOMI Cancer Center - Clinica Mi Tres Torres
  • Girona, Spain
    • Institut Catala d'Oncologia de Girona -Hospital Universitari Dr Josep Trueta
  • Jerez de la Frontera, Spain
    • Hospital Universitario de Jerez
  • Madrid, Spain
    • Hospital Universitario 12 de Octubre
  • Madrid, Spain
    • Clinica Universidad de Navarra
  • Madrid, Spain
    • Hospital Universitario La Paz
  • Madrid, Spain
    • Hospital Universitario Fundacion Jimenez Diaz
  • Madrid, Spain
    • Hospital HM Sanchinarro
  • Málaga, Spain
    • Hospital Regional Universitario de Malaga
  • Seville, Spain
    • Hospital Universitario Virgen Macarena
  • Seville, Spain
    • Hospital Universitario Virgen del Rocio
  • Seville, Spain
    • Hospital Universitario Virgen de Valme
  • Valencia, Spain
    • Hospital Clínico Universitario de Valencia
  • Valencia, Spain
    • Hospital Universitari i Politecnic La Fe
  • Barcelona
    • Barcelona, Barcelona, Spain
      • Institut Catala d'Oncologia Badalona (ICO Badalona) - Hospital Universitari Germans Trias i Pujol
• Turkey (Türkiye)
  • Ankara, Turkey (Türkiye)
    • Liv Hospital Ankara - Medical Oncology Clinic
  • Ankara, Turkey (Türkiye)
    • 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
  • Edirne, Turkey (Türkiye)
    • Trakya University Health Research and Application Center Hospital
  • Istanbul, Turkey (Türkiye)
    • Bezmialem Vakif University
  • Kadıköy, Turkey (Türkiye)
    • Goztepe Prof. Dr. Suleyman Yalcin City Hospital
  • Konya, Turkey (Türkiye)
    • Necmettin Erbakan University Meram Faculty of Medicine
• United States
  • California
    • Glendale, California, United States, 91203
      • OPN Healthcare, Inc.
    • Vallejo, California, United States, 94589
      • Kaiser Permanente Medical Center
  • Colorado
    • Aurora, Colorado, United States, 80045
      • University of Colorado Hospital - Anschutz Cancer Pavilion
  • Florida
    • Margate, Florida, United States, 33054
      • D&H Cancer Research Center LLC
    • Plantation, Florida, United States, 33324
      • BRCR Medical Center Inc.
  • New York
    • New York, New York, United States, 10032
      • Columbia University Medical Center
    • New York, New York, United States, 10016
      • NYU Laura & Issac Perlmutter Cancer Center at NYU Langone Health
  • Ohio
    • Canton, Ohio, United States, 44718
      • Gabrail Cancer Center Research
    • Columbus, Ohio, United States, 43210
      • OSU Brain & Spine Hospital
  • Oregon
    • Portland, Oregon, United States, 97213
      • Providence Portland Institute Franz
  • Texas
    • Dallas, Texas, United States, 75246
      • Texas Oncology - Baylor Charles A. Sammons Cancer Center
    • Houston, Texas, United States, 77030
      • The University of Texas MD Anderson Cancer Center
    • Weslaco, Texas, United States, 78596
      • exas Oncology--McAllen
  • Virginia
    • Charlottesville, Virginia, United States, 22908
      • University of Virginia Comprehensive Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Aged at least 18 years old (or per local regulatory/IRB requirement).
2. 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.
3. Adequate tumor tissue available, for central laboratory confirmation of EGFR exon 20 insertion mutation
4. At least 1 measurable lesion per RECIST Version 1.1
5. Life expectancy ≥ 12 weeks
6. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
7. Adequate organ and hematologic function

Exclusion Criteria:

1. Prior treatment with any systemic anti-cancer therapy for locally advanced or metastatic NSCLC.
2. Spinal cord compression or leptomeningeal metastasis.
3. Concurrent EGFR mutations: exon 19 deletion, L858R, T790M, G719X, S768I, or L861Q.
4. History of stroke or intracranial hemorrhage within 6 months before randomization.
5. 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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Platinum-based Chemotherapy	Drug: Pemetrexed+carboplatin; 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.
Experimental: sunvozertinib	Drug: sunvozertinib; orally, 300 mg, once daily until a treatment discontinuation criterion is met.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
Overall Survival	Up to approximately 34 months after the first participant is randomized

Collaborators and Investigators

• Sponsor: Dizal Pharmaceuticals
• Investigators: Principal Investigator: Caicun Zhou, Shanghai Pulmonary Hospital, Shanghai, China

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): December 13, 2022
• Primary Completion (Actual): January 16, 2026
• Study Completion (Estimated): October 31, 2027

Study Registration Dates

• First Submitted: December 20, 2022
• First Submitted That Met QC Criteria: December 20, 2022
• First Posted (Actual): December 30, 2022

Study Record Updates

• Last Update Posted (Actual): May 26, 2026
• Last Update Submitted That Met QC Criteria: May 21, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Lung Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Carcinoma, Non-Small-Cell Lung; Antineoplastic Agents; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Folic Acid Antagonists; Nucleic Acid Synthesis Inhibitors; Pemetrexed; Carboplatin
• Other Study ID Numbers: DZ2022E0005

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No