NCT05668988Active, not recruitingPhase 3
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
Source: ClinicalTrials.gov · Last updated 29 Oct 2026
Brief summary (registry, in English)
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).
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 324 (actual)
- First submitted
- 20 Dec 2022
- Start date
- 13 Dec 2022
- Primary completion date
- 16 Jan 2026
- Lead sponsor
- Dizal Pharmaceuticals
- Diseases
- Lung cancer
- NCT number
- NCT05668988
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 324
- From 13 Dec 2022 to the primary completion date, 16 Jan 2026
- 154 sites in 15 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior treatment with any systemic anti-cancer therapy for locally advanced or metastatic NSCLC.
- History of stroke or intracranial hemorrhage within 6 months before randomization.
Other illness
- 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).
Lab values
- Concurrent EGFR mutations: exon 19 deletion, L858R, T790M, G719X, S768I, or L861Q.
Other
- Spinal cord compression or leptomeningeal metastasis.
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (154)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Centro Medico Austral Coordinator of this site? Confirm its status | Buenos Aires | Argentina | Unknown status |
| Fundacion Cenit Para El Estudio De Neurociencias Coordinator of this site? Confirm its status | Buenos Aires | Argentina | Unknown status |
| Consultorios Medicos Dr. Doreski - Fundacion Respirar Coordinator of this site? Confirm its status | Buenos Aires | Argentina | Unknown status |
| Instituto Argentino de Diagnositco y Tratamiento S.A Coordinator of this site? Confirm its status | Buenos Aires | Argentina | Unknown status |
| Fundacion Estudios Clinicos Coordinator of this site? Confirm its status | Rosario | Argentina | Unknown status |
| Fundación Ars Médica Coordinator of this site? Confirm its status | San Salvador | Argentina | Unknown status |
| Ordensklinikum Linz GmbH Elisabethinen Coordinator of this site? Confirm its status | Linz | Austria | Unknown status |
| Uniklinikum Salzburg Universitatsklinik fur Innere Medizin Ⅲ Coordinator of this site? Confirm its status | Salzburg | Austria | Unknown status |
| Concord Repatriation General Hospital Coordinator of this site? Confirm its status | Concord | Australia | Unknown status |
| Peter MacCallum Cancer Centre Coordinator of this site? Confirm its status | Melbourne | Australia | Unknown status |
| Sir Charles Gairdner Hospital Coordinator of this site? Confirm its status | Nedlands | Australia | Unknown status |
| Prince of Wales Hospital Coordinator of this site? Confirm its status | Randwick | Australia | Unknown status |
| Grand Hopital de Charleroi Coordinator of this site? Confirm its status | Charleroi | Belgium | Unknown status |
| Universitair Ziekenhuis Antwerpen Coordinator of this site? Confirm its status | Edegem | Belgium | Unknown status |
| UZ Gent Coordinator of this site? Confirm its status | Ghent | Belgium | Unknown status |
| Fundacao PIO XII - Hospital do Cancer de Barretos Coordinator of this site? Confirm its status | Barretos | Brazil | Unknown status |
| Hospital Evangelico de Cachoeiro de Itapemirim Coordinator of this site? Confirm its status | Cachoeiro de Itapemirim | Brazil | Unknown status |
| Liga Norte Riograndense Contra o Cancer Coordinator of this site? Confirm its status | Natal | Brazil | Unknown status |
| Uniao Brasileira de Educacao e Assistencia Hospital Sao Lucas da PUCRS Coordinator of this site? Confirm its status | Porto Alegre | Brazil | Unknown status |
| Irmandade Da Santa Casa de Misericordia de Porto Alegre Coordinator of this site? Confirm its status | Porto Alegre | Brazil | Unknown status |
| Instituto D'Or de Pesquisa e Ensino Coordinator of this site? Confirm its status | Recife | Brazil | Unknown status |
| Instituto D'Or de Pesquisa e Ensino Coordinator of this site? Confirm its status | Rio de Janeiro | Brazil | Unknown status |
| Instituto de Educacao, Pesquisa d Gestao em Saude Coordinator of this site? Confirm its status | Rio de Janeiro | Brazil | Unknown status |
| Instituto Nacional de Câncer - INCA Coordinator of this site? Confirm its status | Rio de Janeiro | Brazil | Unknown status |
| Instituto do Cancer do Estado de Sao Paulo - ICESP Coordinator of this site? Confirm its status | São Paulo | Brazil | Unknown status |
| London Regional Cancer Program London Health Sciences Centre Coordinator of this site? Confirm its status | London | Canada | Unknown status |
| The Ottawa Hospital Cancer Center Coordinator of this site? Confirm its status | Ottawa | Canada | Unknown status |
| Princess Margaret Cancer Center, University Health Network Coordinator of this site? Confirm its status | Toronto | Canada | Unknown status |
| Peking University Third Hospital Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
| Beijing chest hospital, Capital Medical University Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
| Cancer Hospital of the Chinese Academy of Medical Sciences Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
| Peking Union Medical College Hospital Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
| Beijing Cancer Hospital Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
| Hunan Cancer Hospital Coordinator of this site? Confirm its status | Changsha | China | Unknown status |
| West China Hospital of Sichuan University Coordinator of this site? Confirm its status | Chengdu | China | Unknown status |
| Chongqing Cancer Hospital Coordinator of this site? Confirm its status | Chongqing | China | Unknown status |
| Fujian Medical University Union Hospital Coordinator of this site? Confirm its status | Fuzhou | China | Unknown status |
| Fujian Cancer Hospital Coordinator of this site? Confirm its status | Fuzhou | China | Unknown status |
| the First Affiliated Hospital of Sun Yat-sen University Coordinator of this site? Confirm its status | Guangzhou | China | Unknown status |
| The First Affiliated Hospital of Guangzhou Medical University Coordinator of this site? Confirm its status | Guangzhou | China | Unknown status |
| The First Affiliated Hospital Zhejiang University School of Medicine Coordinator of this site? Confirm its status | Hangzhou | China | Unknown status |
| Zhejiang Cancer Hospital Coordinator of this site? Confirm its status | Hangzhou | China | Unknown status |
| Harbin Medical University Cancer Hospital Coordinator of this site? Confirm its status | Harbin | China | Unknown status |
| The First Affiliated Hospital of Anhui Medical University Coordinator of this site? Confirm its status | Hefei | China | Unknown status |
| Anhui Provincial Hospital Coordinator of this site? Confirm its status | Hefei | China | Unknown status |
| The Affiliated Hospital of Inner Mongolia Medical University Coordinator of this site? Confirm its status | Hohhot | China | Unknown status |
| Jilin Cancer Hospital Coordinator of this site? Confirm its status | Jilin City | China | Unknown status |
| Shandong Cancer Hospital & Institution Coordinator of this site? Confirm its status | Jinan | China | Unknown status |
| Central Hospital Affiliated to Shandong First Medical University Coordinator of this site? Confirm its status | Jinan | China | Unknown status |
| Yunnan Cancer Hospital Coordinator of this site? Confirm its status | Kunming | China | Unknown status |
| The Second Affiliated Hospital of Nanchang University Coordinator of this site? Confirm its status | Nanchang | China | Unknown status |
| Jiangsu Cancer Hospital Coordinator of this site? Confirm its status | Nanjing | China | Unknown status |
| Jiangsu Provincial Hospital Coordinator of this site? Confirm its status | Nanjing | China | Unknown status |
| Guangxi Medical University Cancer Hospital Coordinator of this site? Confirm its status | Nanning | China | Unknown status |
| Zhongshan Hospital,Fudan University Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
| Shanghai Pulmonary Hospital Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
| Shanghai Chest Hospital Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
| The First Hospital of China Medical University Coordinator of this site? Confirm its status | Shenyang | China | Unknown status |
| Cancer Hospital Chinese Academy Of Medical Sciences, Shenzhen Center Coordinator of this site? Confirm its status | Shenzhen | China | Unknown status |
| The Fourth Hospital of Hebei Medical University Coordinator of this site? Confirm its status | Shijiazhuang | China | Unknown status |
| Shanxi Provincial Cancer Hospital Coordinator of this site? Confirm its status | Taiyuan | China | Unknown status |
| Taizhou Hospital of Zhejiang Province Coordinator of this site? Confirm its status | Taizhou | China | Unknown status |
| Tianjin Medical University Cancer Institute & Hospital Coordinator of this site? Confirm its status | Tianjin | China | Unknown status |
| The Affiliated Cancer Hospital of Xinjiang Medical University Coordinator of this site? Confirm its status | Ürümqi | China | Unknown status |
| Union Hospital, Tongji Medical College, Huazhong University of Science and Technology Coordinator of this site? Confirm its status | Wuhan | China | Unknown status |
| Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science & Technology Coordinator of this site? Confirm its status | Wuhan | China | Unknown status |
| The First Affiliated Hospital of Xi'an Jiaotong University Coordinator of this site? Confirm its status | Xi’an | China | Unknown status |
| Yantai Yuhuangding Hospital Coordinator of this site? Confirm its status | Yantai | China | Unknown status |
| The First Affiliated Hospital of Zhengzhou University Coordinator of this site? Confirm its status | Zhengzhou | China | Unknown status |
| Henan Cancer Hospital Coordinator of this site? Confirm its status | Zhengzhou | China | Unknown status |
| Fakultni nemocnice Olomouc Coordinator of this site? Confirm its status | Olomouc | Czechia | Unknown status |
| Nemocnice AGEL Ostrava - Vitkovice a.s. Coordinator of this site? Confirm its status | Ostrava | Czechia | Unknown status |
| Evangelische Lungenklinik Berlin Coordinator of this site? Confirm its status | Berlin | Germany | Unknown status |
| Asklepios Klinik Gauting GmbH Coordinator of this site? Confirm its status | Gauting | Germany | Unknown status |
| MVZ Ⅱ der Niels Stensen Kliniken Coordinator of this site? Confirm its status | Georgsmarienhütte | Germany | Unknown status |
| Thoraxklinik Heidelberg gGmbH Coordinator of this site? Confirm its status | Heidelberg | Germany | Unknown status |
| Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz - III. Medizinische Klinik und Poliklinik Coordinator of this site? Confirm its status | Mainz | Germany | Unknown status |
| Universitatsklinik Innere Medizin-Onkologie Coordinator of this site? Confirm its status | Oldenburg | Germany | Unknown status |
| Complejo Hospitalario Universitario A Coruña Coordinator of this site? Confirm its status | A Coruña | Spain | Unknown status |
| Institut Catala d'Oncologia Badalona (ICO Badalona) - Hospital Universitari Germans Trias i Pujol Coordinator of this site? Confirm its status | Barcelona | Spain | Unknown status |
| UOMI Cancer Center - Clinica Mi Tres Torres Coordinator of this site? Confirm its status | Barcelona | Spain | Unknown status |
| Hospital Universitari Vall d'Hebron Coordinator of this site? Confirm its status | Barcelona | Spain | Unknown status |
| Hospital de la Santa Creu i Sant Pau Coordinator of this site? Confirm its status | Barcelona | Spain | Unknown status |
| Hospital Universitari Dexeus Coordinator of this site? Confirm its status | Barcelona | Spain | Unknown status |
| Institut Catala d'Oncologia de Girona -Hospital Universitari Dr Josep Trueta Coordinator of this site? Confirm its status | Girona | Spain | Unknown status |
| Hospital Universitario De Jerez Coordinator of this site? Confirm its status | Jerez de la Frontera | Spain | Unknown status |
| Hospital Universitario La Paz Coordinator of this site? Confirm its status | Madrid | Spain | Unknown status |
| Hospital HM Sanchinarro Coordinator of this site? Confirm its status | Madrid | Spain | Unknown status |
| Clinica Universidad de Navarra Coordinator of this site? Confirm its status | Madrid | Spain | Unknown status |
| Hospital Universitario Fundación Jiménez Díaz Coordinator of this site? Confirm its status | Madrid | Spain | Unknown status |
| Hospital Universitario 12 de Octubre Coordinator of this site? Confirm its status | Madrid | Spain | Unknown status |
| Hospital Regional Universitario de Malaga Coordinator of this site? Confirm its status | Málaga | Spain | Unknown status |
| Hospital Universitario Virgen de Valme Coordinator of this site? Confirm its status | Seville | Spain | Unknown status |
| Hospital Universitario Virgen del Rocio Coordinator of this site? Confirm its status | Seville | Spain | Unknown status |
| Hospital Universitario Virgen Macarena Coordinator of this site? Confirm its status | Seville | Spain | Unknown status |
| Hospital Clinico Universitario de Valencia Coordinator of this site? Confirm its status | Valencia | Spain | Unknown status |
| Hospital Universitari i Politécnic La Fe Coordinator of this site? Confirm its status | Valencia | Spain | Unknown status |
| Centre Hospitalier Universitaire D'Angers Coordinator of this site? Confirm its status | Angers | France | Unknown status |
| HCL - Hôpital Louis Pradel Coordinator of this site? Confirm its status | Bron | France | Unknown status |
| Centre Hospitalier Intercommunal de Creteil (CHIC Coordinator of this site? Confirm its status | Créteil | France | Unknown status |
| Centre Hospitalier Universitaire (CHU) Grenobles Alpes- Hôpital Albert Michallon Coordinator of this site? Confirm its status | Hellemmes-Lille | France | Unknown status |
| Centre Hospitalier Universitaire Grenoble Alpes (CHU Grenoble Alpes) - Hopital Albert Michallon Coordinator of this site? Confirm its status | La Tronche | France | Unknown status |
| Assistance Publique Hopitaux de Marseille (AP-HM) Hopital Nord Coordinator of this site? Confirm its status | Marseille | France | Unknown status |
| Centre de Cancérologie du Grand Montpellier Coordinator of this site? Confirm its status | Montpellier | France | Unknown status |
| AP-HP Hôpital Cochin Coordinator of this site? Confirm its status | Paris | France | Unknown status |
| Hopital Bichat - Claude Bernard - AP-HP Coordinator of this site? Confirm its status | Paris | France | Unknown status |
| Hôpital Paris Saint Joseph Coordinator of this site? Confirm its status | Paris | France | Unknown status |
| Assistance Publique-Hopitaux de Paris (AP-HP)- Hopital Tenon Coordinator of this site? Confirm its status | Paris | France | Unknown status |
| Cetre Hospitalier Universitaire de Poitiers Coordinator of this site? Confirm its status | Poitiers | France | Unknown status |
| Institut de Cancérologie de l'Ouest Coordinator of this site? Confirm its status | Saint-Herblain | France | Unknown status |
| CHU de Nantes - Saint Herblain Coordinator of this site? Confirm its status | Saint-Herblain | France | Unknown status |
| Hopital d'Instruction des Armees (HIA) Begin Coordinator of this site? Confirm its status | Saint-Mandé | France | Unknown status |
| Hopital Foch Coordinator of this site? Confirm its status | Suresnes | France | Unknown status |
| Centro di Riferimento Oncologico di Aviano (CRO)-IRCCS Coordinator of this site? Confirm its status | Aviano | Italy | Unknown status |
| IRCCS Azienda Ospedaliero-Universitaria di Bologna - Policlinico Sant'Orsola Coordinator of this site? Confirm its status | Bologna | Italy | Unknown status |
| Aou Policlinico G. Rodolico - S. Marcoa Coordinator of this site? Confirm its status | Catania | Italy | Unknown status |
| Azienda Ospedaliero-Universitaria Careggi (AOUC) - SC di Oncologia MedicaI Coordinator of this site? Confirm its status | Florence | Italy | Unknown status |
| Azienda USL Toscana Sud Est -Ospedale Misericordia - Grosseto Coordinator of this site? Confirm its status | Grosseto | Italy | Unknown status |
| Istituto Scientifico Romagnolo per lo Studio e La Cura dei Tumori Srl (IRST) Coordinator of this site? Confirm its status | Meldola | Italy | Unknown status |
| Azienda Ospedaliero - Universitaria di Modena Coordinator of this site? Confirm its status | Modena | Italy | Unknown status |
| Fondazione IRCCS San Gerardo dei Tintori Coordinator of this site? Confirm its status | Monza | Italy | Unknown status |
| Casa di Cura di Alta Specialita - Palermo Coordinator of this site? Confirm its status | Palermo | Italy | Unknown status |
| Azienda Ospedaliero Universitaria di Parma Coordinator of this site? Confirm its status | Parma | Italy | Unknown status |
| Ausl Della Romagna-Po Ravenna Lugo Faenza Coordinator of this site? Confirm its status | Ravenna | Italy | Unknown status |
| AUSL IRCCS di Reggio Emilia Coordinator of this site? Confirm its status | Reggio Emilia | Italy | Unknown status |
| IRCCS Istituti Fisioterapici Ospitalieri- Istituto Nazionale tumori Regina Elena Coordinator of this site? Confirm its status | Roma | Italy | Unknown status |
| Azienda Ospedaliera Universitaria Senese - Ospedale Senta Maria alle Coordinator of this site? Confirm its status | Siena | Italy | Unknown status |
| Klinika Onkologii i Radioterapii Uniwersyteckie Centrum Kliniczne (UCK) Coordinator of this site? Confirm its status | Gdansk | Poland | Unknown status |
| Med Polonia Sp z o.o. Coordinator of this site? Confirm its status | Poznan | Poland | Unknown status |
| Wojewódzki Szpital im. św. Ojca Pio Coordinator of this site? Confirm its status | Przemyśl | Poland | Unknown status |
| Narodowy Instytut Onkologii im. M. Sklodowskiej-Curie Coordinator of this site? Confirm its status | Warsaw | Poland | Unknown status |
| University of Colorado Hospital Anschutz Cancer Pavilion Coordinator of this site? Confirm its status | Aurora | United States | Unknown status |
| Gabrail Cancer Center Research Coordinator of this site? Confirm its status | Canton | United States | Unknown status |
| University of Virginia Comprehensive Cancer Center Coordinator of this site? Confirm its status | Charlottesville | United States | Unknown status |
| OSU Brain & Spine Hospital Coordinator of this site? Confirm its status | Columbus | United States | Unknown status |
| Texas Oncology - Baylor Charles A. Sammons Cancer Center Coordinator of this site? Confirm its status | Dallas | United States | Unknown status |
| OPN Healthcare, Inc Coordinator of this site? Confirm its status | Glendale | United States | Unknown status |
| The University of Texas MD Anderson Cancer Center Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
| D&H Cancer Research Center LLC Coordinator of this site? Confirm its status | Margate | United States | Unknown status |
| NYU Laura & Issac Perlmutter Cancer Center at NYU Langone Health Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| Columbia University Medical Center Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| NYU Langone Health Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| BRCR Medical Center Inc Coordinator of this site? Confirm its status | Plantation | United States | Unknown status |
| Providence Portland Institute Franz Coordinator of this site? Confirm its status | Portland | United States | Unknown status |
| Kaiser Permanente Medical Center Coordinator of this site? Confirm its status | Vallejo | United States | Unknown status |
| exas Oncology--McAllen Coordinator of this site? Confirm its status | Weslaco | United States | Unknown status |
| Ankara Bilkent City Hospital Coordinator of this site? Confirm its status | Ankara | Turkey (Türkiye) | Unknown status |
| Liv Hospital Ankara - Medical Oncology Clinic Coordinator of this site? Confirm its status | Ankara | Turkey (Türkiye) | Unknown status |
| Dr. Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital Coordinator of this site? Confirm its status | Ankara | Turkey (Türkiye) | Unknown status |
| Gazi University Faculty of Medicine Hospital Coordinator of this site? Confirm its status | Ankara | Turkey (Türkiye) | Unknown status |
| Trakya University Health Research and Application Center Hospital Coordinator of this site? Confirm its status | Edirne | Turkey (Türkiye) | Unknown status |
| Bezmialem Vakif University Coordinator of this site? Confirm its status | Istanbul | Turkey (Türkiye) | Unknown status |
| Goztepe Prof. Dr. Suleyman Yalcin City Hospital Coordinator of this site? Confirm its status | Kadıköy | Turkey (Türkiye) | Unknown status |
| Necmettin Erbakan University Meram Faculty of Medicine Coordinator of this site? Confirm its status | Konya | Turkey (Türkiye) | Unknown status |
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This page is information, not medical advice. Discuss any trial with your doctor.