A Study of DZD9008 Versus Platinum-Based Doublet Chemotherapy in Local Advanced or Metastatic Non-small Cell Lung Cancer (WU-KONG28)
- Conditions
- Non-small Cell Lung Cancer
- Interventions
- Drug: Pemetrexed+carboplatin
- Registration Number
- NCT05668988
- Lead Sponsor
- Dizal Pharmaceuticals
- 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 320
- 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
- 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).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description sunvozertinib sunvozertinib - Platinum-based Chemotherapy Pemetrexed+carboplatin -
- Primary Outcome Measures
Name Time Method 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
Name Time Method Overall Survival Up to approximately 34 months after the first participant is randomized
Trial Locations
- Locations (160)
OPN Healthcare, Inc.
🇺🇸Glendale, California, United States
Kaiser Permanente Medical Center
🇺🇸Vallejo, California, United States
University of Colorado Hospital - Anschutz Cancer Pavilion
🇺🇸Aurora, Colorado, United States
D&H Cancer Research Center
🇺🇸Margate, Florida, United States
Brcr Global
🇺🇸Plantation, Florida, United States
H. Lee Moffitt Cancer Center
🇺🇸Tampa, Florida, United States
NYU Laura & Issac Perlmutter Cancer Center
🇺🇸New York, New York, United States
Columbia University Medical Center
🇺🇸New York, New York, United States
Gabrail Cancer Center Research
🇺🇸Canton, Ohio, United States
The Ohio State University
🇺🇸Columbus, Ohio, United States
Providence Portland Medical Center
🇺🇸Portland, Oregon, United States
USOR - Texas Oncology - Baylor Charles A. Sammons Cancer Center
🇺🇸Dallas, Texas, United States
USOR - Texas Oncology--Weslaco
🇺🇸Weslaco, Texas, United States
University of Virginia Comprehensive Cancer Center
🇺🇸Charlottesville, Virginia, 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 Cancer Centre Medical Oncology Clinical Trials Unit Concord Repatriation General Hospital
🇦🇺Concord, Australia
Peter MacCallum Cancer Centre
🇦🇺Melbourne, Australia
Sir Charles Gairdner Hospital, Heart Research Insititute
🇦🇺Nedlands, Australia
Prince of Wales Hospital
🇦🇺Randwick, Australia
Ordensklinikum Linz GmbH Elisabethinen
🇦🇹Linz, Austria
Uniklinikum Salzburg
🇦🇹Salzburg, Austria
Fundacao PIO XII - Hospital do Cancer de Barretos
🇧🇷Barretos, Brazil
Centro de Pesquisas Clinicas em
🇧🇷Cachoeiro De Itapemirim, Brazil
Liga Norte Riograndense Contra o Câncer
🇧🇷Natal, Brazil
Hospital São Lucas da PUCRS
🇧🇷Porto Alegre, Brazil
Santa Casa de Misericordia- Porto Alegre - Hospital Santa Rita
🇧🇷Porto Alegre, Brazil
Instituto D'Or de Pesquisa e Ensino - Recife
🇧🇷Recife, Brazil
Instituto America(COI)
🇧🇷Rio De Janeiro, Brazil
Instituto D'Or de Pesquisa e Ensino
🇧🇷Rio De Janeiro, Brazil
Instituto Nacional de Cancer Jose Alencar Gomes da Silva
🇧🇷Rio De Janeiro, Brazil
Instituto do Cancer do Estado de Sao Paulo - ICES
🇧🇷São Paulo, Brazil
Regional Cancer Program London Health Sciences Centre
🇨🇦London, Canada
The Ottawa Hospital Cancer Center
🇨🇦Ottawa, Canada
Princess Margaret Cancer Center
🇨🇦Toronto, Canada
Cancer Hospital Chinese Academy of Medical Sciences, ShenZhen center
🇨🇳Shenzhen, China
Fakultni Nemocnice Olomouc (FNOL) - Onkologicka Klinika
🇨🇿Olomouc, Czechia
Vitkovicka Nemocnice a.s. - Plicni oddeleni
🇨🇿Ostrava, Czechia
Centre Hospitalier Universitaire d'Angers
🇫🇷Angers, France
Hôpital Louis Pradel
🇫🇷Bron, France
Centre Hospitalier Intercommunal de Creteil (CHIC)
🇫🇷Créteil, France
Centre Hospitalier Universitaire de Lille (CHU Lille) - Hopital Albert Calmette - Clinique des Maladies Respiratoires
🇫🇷Hellemmes-Lille, France
Centre Hospitalier Universitaire Grenoble Alpes (CHU Grenoble Alpes) - Hopital Albert Michallon
🇫🇷La Tronche, France
APHM-Hôpital NORD
🇫🇷Marseille, France
Centre de Cancérologie Montpellier
🇫🇷Montpellier, France
APHP Hôpital Tenon
🇫🇷Paris, France
Cochin Hospital
🇫🇷Paris, France
Hopital Saint Joseph
🇫🇷Paris, France
Hôpital Bichat - Claude Bernard
🇫🇷Paris, France
CHU Poitiers
🇫🇷Poitiers, France
Centre Hospitalier Universitaire de Nantes (CHU de Nantes)
🇫🇷Saint Herblain, France
Institut de Cancerologie de L'Ouest
🇫🇷Saint Herblain, France
Hopital d'Instruction Des Armees Begin
🇫🇷Saint-Mande, France
Hopital Foch
🇫🇷Suresnes, France
Evangelische Lungenklinik Berlin - Klinik fuer Pneumologie
🇩🇪Berlin, Germany
Asklepios Klinik Gauting GmbH - Klinik fuer Thorakale Onkologie
🇩🇪Gauting, Germany
Niels-Stensen-Kliniken - Franziskus-Hospital Harderberg
🇩🇪Georgsmarienhütte, Germany
Universitaetsklinikum Heidelberg (UKHD) - Thoraxklinik-Heidelberg gGmbH
🇩🇪Heidelberg, Germany
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz - III. Medizinische Klinik und Poliklinik
🇩🇪Mainz, Germany
Pius-Hospital Oldenburg - Klinik fuer Haematologie und Onkologie
🇩🇪Oldenburg, Germany
Centro di Riferimento Oncologico (CRO Aviano)
🇮🇹Aviano, Italy
Azienda Ospedaliero Universitaria di Bologna - Policlinico S. Orsola-Malpighi
🇮🇹Bologna, Italy
Azienda Ospedaliero - Universitaria "Policlinico-Vittorio Emanuele" Catania
🇮🇹Catania, Italy
Università degli Studi di Firenze - Azienda Ospedaliero-Universitaria Careggi (AOUC) - SC di Oncologia MedicaI
🇮🇹Florence, Italy
Azienda USL Toscana Sud Est -Ospedale Misericordia - Grosseto
🇮🇹Grosseto, Italy
Servizio Sanitario Regionale Emilia-Romagna - Istituto Scientifico Romagnolo per lo Studio e La Cura dei Tumori Srl (IRST)
🇮🇹Meldola, Italy
Azienda Ospedaliero-Universitaria di Modena (AOU Modena) - Policlinico di Modena
🇮🇹Modena, Italy
Azienda Ospedaliera San Gerardo - Monza
🇮🇹Monza, Italy
La Maddalena Casa di Cura di Alta Specialita - Palermo
🇮🇹Palermo, Italy
Azienda Ospedaliero-Universitaria di Parma
🇮🇹Parma, Italy
Azienda Unità Sanitaria Locale Romagna
🇮🇹Ravenna, Italy
Azienda Ospedaliera di Reggio Emilia - Arcispedale S. Maria Nuova (ASMN)
🇮🇹Reggio Emilia, Italy
IRCCS Istituti Fisioterapici Ospitalieri- Istituto Nazionale tumori Regina Elena
🇮🇹Roma, Italy
Azienda Ospedaliera Universitaria Senese - Istituto Toscano Tumori (ITT) - Center for Immuno-Oncology (CIO)
🇮🇹Siena, Italy
Universiteit Maastricht (UM) - Maastricht University Medical Centre (Maastricht UMC+)
🇳🇱Maastricht, Netherlands
Uniwersyteckie Centrum Kliniczne, Klinika Onkologii i Radioterapii
🇵🇱Gdańsk, Poland
MED-POLONIA Sp. z o.o.
🇵🇱Poznań, Poland
Wojewódzki Szpital im. św. Ojca Pio
🇵🇱Przemyśl, Poland
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie Panstwowy
🇵🇱Warsaw, Poland
Complejo Hospitalario Universitario A Coruña
🇪🇸A Coruña, Spain
Hospital de la Santa Creu i Sant Pau
🇪🇸Barcelona, Spain
Hospital Universitari Vall d'Hebron
🇪🇸Barcelona, Spain
Institut Catala d'Oncologia Badalona (ICO Badalona) - Hospital Germans Trias i Pujol
🇪🇸Barcelona, Spain
Instituto Oncológico Dr Rosell Hospital Quiron Dexeus
🇪🇸Barcelona, Spain
UOMI Cancer Center - Clinica 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
🇪🇸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
🇪🇸Sevilla, Spain
Hospital Universitario Virgen del Rocio
🇪🇸Sevilla, Spain
Hospital Universitario Virgen Macarena
🇪🇸Sevilla, Spain
Hospital Clinico Universitario de Valencia
🇪🇸Valencia, Spain
Hospital Universitari i Politècnic La Fe
🇪🇸Valencia, Spain
Ankara Bilkent City Hospital Universiteler Mahallesi
🇹🇷Ankara, Turkey
Dr. Abdurrahman Yurtaslan Ankara Oncology Training
🇹🇷Ankara, Turkey
Gazi Universitesi Tip Fakultesi (Gazi University Faculty of Medicine) - Gazi Hastanesi (Gazi Hospital)
🇹🇷Ankara, Turkey
Liv Hospital Ankara - Medical Oncology Clinic
🇹🇷Ankara, Turkey
Trakya Universitesi Saglik Arastirma ve Uygulama Merkezi Hastane
🇹🇷Edirne, Turkey
Bezmialem University Hospital
🇹🇷Istanbul, Turkey
Prof. Dr. Süleyman Yalçın Şehir Hastanesi - Tibbi Onkoloji Klinigi
🇹🇷Kadıköy, Turkey
Necmettin Erbakan University
🇹🇷Konya, Turkey
MD Anderson cancer center
🇺🇸Houston, Texas, United States
Antwerpen University Hospital (UZA)
🇧🇪Edegem, Antwerp, Belgium
University Hospital Gent- Drug Research Unit Ghent (D.R.U.G.)
🇧🇪Ghent, Flanders, Belgium
Grand Hopital de Charleroi (GHdC) - Hopital Notre Dame
🇧🇪Charleroi, Hainaut, Belgium
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
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