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A Study of DZD9008 Versus Platinum-Based Doublet Chemotherapy in Local Advanced or Metastatic Non-small Cell Lung Cancer (WU-KONG28)
Sponsor: Dizal Pharmaceuticals
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).
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
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
324
Start Date
2022-12-13
Completion Date
2027-10-31
Last Updated
2026-10-29
Healthy Volunteers
No
Conditions
Interventions
sunvozertinib
orally, 300 mg, once daily until a treatment discontinuation criterion is met.
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.
Locations (154)
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 LLC
Margate, Florida, United States
BRCR Medical Center Inc.
Plantation, Florida, United States
NYU Langone Health
New York, New York, United States
NYU Laura & Issac Perlmutter Cancer Center at NYU Langone Health
New York, New York, United States
Columbia University Medical Center
New York, New York, United States
Gabrail Cancer Center Research
Canton, Ohio, United States
OSU Brain & Spine Hospital
Columbus, Ohio, United States
Providence Portland Institute Franz
Portland, Oregon, United States
Texas Oncology - Baylor Charles A. Sammons Cancer Center
Dallas, Texas, United States
The University of Texas MD Anderson cancer center
Houston, Texas, United States
exas Oncology--McAllen
Weslaco, Texas, United States
University of Virginia Comprehensive Cancer Center
Charlottesville, Virginia, United States
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
Instituto Argentino de Diagnositco y Tratamiento S.A
Buenos Aires, Argentina
Fundación Estudios Clínicos
Rosario, Argentina
Fundación Ars Médica
San Salvador, 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
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 City, 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
The Affiliated Cancer Hospital of Xinjiang Medical University
Ürümqi, 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