Clinical trial NCT05668988: A Study of DZD9008 Versus Platinum-Based Doublet Chemotherapy in Local Advanced or Metastatic Non-small Cell Lung Cancer (WU-KONG28)
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Non-small Cell Lung Cancer
Lead sponsor: Dizal Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2022-12-30
Enrollment: 320
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


Eligibility criteria: 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).

Primary outcomes:
measure: Progression Free Survival (PFS) as assessed by Blinded Independent Central Review (BICR) per RECIST 1.1
timeFrame: Up to approximately 34 months after the first participant is randomized
Secondary outcomes:
measure: Overall Survival
timeFrame: Up to approximately 34 months after the first participant is randomized
Other outcomes:
Locations:
city: Glendale
country: United States
facility: OPN Healthcare, Inc.
state: California
city: Vallejo
country: United States
facility: Kaiser Permanente Medical Center
state: California
city: Aurora
country: United States
facility: University of Colorado Hospital - Anschutz Cancer Pavilion
state: Colorado
city: Margate
country: United States
facility: D&H Cancer Research Center
state: Florida
city: Plantation
country: United States
facility: Brcr Global
state: Florida
city: Tampa
country: United States
facility: H. Lee Moffitt Cancer Center
state: Florida
city: New York
country: United States
facility: NYU Laura & Issac Perlmutter Cancer Center
state: New York
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
city: Canton
country: United States
facility: Gabrail Cancer Center Research
state: Ohio
city: Columbus
country: United States
facility: The Ohio State University
state: Ohio
city: Portland
country: United States
facility: Providence Portland Medical Center
state: Oregon
city: Dallas
country: United States
facility: USOR - Texas Oncology - Baylor Charles A. Sammons Cancer Center
state: Texas
city: Houston
country: United States
facility: MD Anderson cancer center
state: Texas
city: Weslaco
country: United States
facility: USOR - Texas Oncology--Weslaco
state: Texas
city: Charlottesville
country: United States
facility: University of Virginia Comprehensive Cancer Center
state: Virginia
city: Buenos Aires
country: Argentina
facility: Centro de Educación Médica e Investigaciones Clínicas, CEMIC
city: Buenos Aires
country: Argentina
facility: Centro Diabaid
city: Buenos Aires
country: Argentina
facility: Centro Medico Austral
city: Buenos Aires
country: Argentina
facility: Consultorios Medicos Dr. Doreski - Fundacion Respirar
city: Buenos Aires
country: Argentina
facility: Fundacion Cenit Para El Estudio De Neurociencias
city: Buenos Aires
country: Argentina
facility: Hospital Italiano de Buenos Aires (HIBA)
city: Buenos Aires
country: Argentina
facility: Instituto Alexander Fleming
city: Buenos Aires
country: Argentina
facility: Instituto Argentino de Diagnositco y Tratamiento S.A
city: Rosario
country: Argentina
facility: Fundación Estudios Clínicos
city: San Salvador
country: Argentina
facility: Fundación Ars Médica
city: Viedma
country: Argentina
facility: Centro de Investigación Clínicas. Clinica Viedma S.A
city: Concord
country: Australia
facility: Concord Cancer Centre Medical Oncology Clinical Trials Unit Concord Repatriation General Hospital
city: Melbourne
country: Australia
facility: Peter MacCallum Cancer Centre
city: Nedlands
country: Australia
facility: Sir Charles Gairdner Hospital, Heart Research Insititute
city: Randwick
country: Australia
facility: Prince of Wales Hospital
city: Linz
country: Austria
facility: Ordensklinikum Linz GmbH Elisabethinen
city: Salzburg
country: Austria
facility: Uniklinikum Salzburg
city: Edegem
country: Belgium
facility: Antwerpen University Hospital (UZA)
state: Antwerp
city: Ghent
country: Belgium
facility: University Hospital Gent- Drug Research Unit Ghent (D.R.U.G.)
state: Flanders
city: Charleroi
country: Belgium
facility: Grand Hopital de Charleroi (GHdC) - Hopital Notre Dame
state: Hainaut
city: Barretos
country: Brazil
facility: Fundacao PIO XII - Hospital do Cancer de Barretos
city: Cachoeiro De Itapemirim
country: Brazil
facility: Centro de Pesquisas Clinicas em
city: Natal
country: Brazil
facility: Liga Norte Riograndense Contra o Câncer
city: Porto Alegre
country: Brazil
facility: Hospital São Lucas da PUCRS
city: Porto Alegre
country: Brazil
facility: Santa Casa de Misericordia- Porto Alegre - Hospital Santa Rita
city: Recife
country: Brazil
facility: Instituto D'Or de Pesquisa e Ensino - Recife
city: Rio De Janeiro
country: Brazil
facility: Instituto America(COI)
city: Rio De Janeiro
country: Brazil
facility: Instituto D'Or de Pesquisa e Ensino
city: Rio De Janeiro
country: Brazil
facility: Instituto Nacional de Cancer Jose Alencar Gomes da Silva
city: São Paulo
country: Brazil
facility: Instituto do Cancer do Estado de Sao Paulo - ICES
city: London
country: Canada
facility: Regional Cancer Program London Health Sciences Centre
city: Ottawa
country: Canada
facility: The Ottawa Hospital Cancer Center
city: Toronto
country: Canada
facility: Princess Margaret Cancer Center
city: Beijing
country: China
facility: Beijing Cancer Hospital
city: Beijing
country: China
facility: Beijing Chest Hospital, Capital Medical University
city: Beijing
country: China
facility: Cancer Hospital of the Chinese Academy of Medical Sciences
city: Beijing
country: China
facility: Peking Union Medical College Hospital
city: Beijing
country: China
facility: Peking University Third Hospital
city: Changsha
country: China
facility: Hunan Cancer Hospital
city: Chengdu
country: China
facility: West China Hospital of Sichuan University
city: Chongqing
country: China
facility: Army Medical Center of PLA
city: Chongqing
country: China
facility: Chongqing Cancer Hospital
city: Fuzhou
country: China
facility: Fujian Cancer Hospital
city: Fuzhou
country: China
facility: Fujian Medical University Union Hospital
city: Guangzhou
country: China
facility: The First Affiliated Hospital of Guangzhou Medical University
city: Guangzhou
country: China
facility: The First Affiliated Hospital of Sun Yat-sen University
city: Hangzhou
country: China
facility: The First Affiliated Hospital Zhejiang University School of Medicine
city: Hangzhou
country: China
facility: Zhejiang Cancer Hospital
city: Harbin
country: China
facility: Harbin Medical University Cancer Hospital
city: Hefei
country: China
facility: Anhui Provincial Hospital
city: Hefei
country: China
facility: The First Affiliated Hospital of Anhui Medical University
city: Hohhot
country: China
facility: The Affiliated Hospital of Inner Mongolia Medical University
city: Jilin
country: China
facility: Jilin Cancer Hospital
city: Jinan
country: China
facility: Central Hospital Affiliated to Shandong First Medical University
city: Jinan
country: China
facility: Shandong Cancer Hospital & Institution
city: Kunming
country: China
facility: Yunnan Cancer Hospital
city: Nanchang
country: China
facility: The Second Affiliated Hospital of Nanchang University
city: Nanjing
country: China
facility: Jiangsu Cancer Hospital
city: Nanjing
country: China
facility: Jiangsu Provincial Hospital
city: Nanning
country: China
facility: Guangxi Medical University Cancer Hospital
city: Shanghai
country: China
facility: Shanghai Chest Hospital
city: Shanghai
country: China
facility: Shanghai Pulmonary Hospital
city: Shanghai
country: China
facility: ZhongShan Hospital Fudan University
city: Shenyang
country: China
facility: The First Hospital of China Medical University
city: Shenzhen
country: China
facility: Cancer Hospital Chinese Academy of Medical Sciences, ShenZhen center
city: Shijiazhuang
country: China
facility: The Fourth Hospital of Hebei Medical University
city: Taiyuan
country: China
facility: Shanxi Provincial Cancer Hospital
city: Taizhou
country: China
facility: Taizhou Hospital of Zhejiang Province
city: Tianjin
country: China
facility: Tianjin Medical University Cancer Institute & Hospital
city: Wuhan
country: China
facility: Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science & Technology
city: Wuhan
country: China
facility: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
city: Xi'an
country: China
facility: The First Affiliated Hospital of Xi 'an Jiaotong University
city: Yantai
country: China
facility: Yantai Yuhuangding Hospital
city: Zhengzhou
country: China
facility: Henan Cancer Hospital
city: Zhengzhou
country: China
facility: The First Affiliated Hospital of Zhengzhou University
city: Olomouc
country: Czechia
facility: Fakultni Nemocnice Olomouc (FNOL) - Onkologicka Klinika
city: Ostrava
country: Czechia
facility: Vitkovicka Nemocnice a.s. - Plicni oddeleni
city: Angers
country: France
facility: Centre Hospitalier Universitaire d'Angers
city: Bron
country: France
facility: Hôpital Louis Pradel
city: Créteil
country: France
facility: Centre Hospitalier Intercommunal de Creteil (CHIC)
city: Hellemmes-Lille
country: France
facility: Centre Hospitalier Universitaire de Lille (CHU Lille) - Hopital Albert Calmette - Clinique des Maladies Respiratoires
city: La Tronche
country: France
facility: Centre Hospitalier Universitaire Grenoble Alpes (CHU Grenoble Alpes) - Hopital Albert Michallon
city: Marseille
country: France
facility: APHM-Hôpital NORD
city: Montpellier
country: France
facility: Centre de Cancérologie Montpellier
city: Paris
country: France
facility: APHP Hôpital Tenon
city: Paris
country: France
facility: Cochin Hospital
city: Paris
country: France
facility: Hopital Saint Joseph
city: Paris
country: France
facility: Hôpital Bichat - Claude Bernard
city: Poitiers
country: France
facility: CHU Poitiers
city: Saint Herblain
country: France
facility: Centre Hospitalier Universitaire de Nantes (CHU de Nantes)
city: Saint Herblain
country: France
facility: Institut de Cancerologie de L'Ouest
city: Saint-Mande
country: France
facility: Hopital d'Instruction Des Armees Begin
city: Suresnes
country: France
facility: Hopital Foch
city: Berlin
country: Germany
facility: Evangelische Lungenklinik Berlin - Klinik fuer Pneumologie
city: Gauting
country: Germany
facility: Asklepios Klinik Gauting GmbH - Klinik fuer Thorakale Onkologie
city: Georgsmarienhütte
country: Germany
facility: Niels-Stensen-Kliniken - Franziskus-Hospital Harderberg
city: Heidelberg
country: Germany
facility: Universitaetsklinikum Heidelberg (UKHD) - Thoraxklinik-Heidelberg gGmbH
city: Mainz
country: Germany
facility: Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz - III. Medizinische Klinik und Poliklinik
city: Oldenburg
country: Germany
facility: Pius-Hospital Oldenburg - Klinik fuer Haematologie und Onkologie
city: Aviano
country: Italy
facility: Centro di Riferimento Oncologico (CRO Aviano)
city: Bologna
country: Italy
facility: Azienda Ospedaliero Universitaria di Bologna - Policlinico S. Orsola-Malpighi
city: Catania
country: Italy
facility: Azienda Ospedaliero - Universitaria "Policlinico-Vittorio Emanuele" Catania
city: Florence
country: Italy
facility: Università degli Studi di Firenze - Azienda Ospedaliero-Universitaria Careggi (AOUC) - SC di Oncologia MedicaI
city: Grosseto
country: Italy
facility: Azienda USL Toscana Sud Est -Ospedale Misericordia - Grosseto
city: Meldola
country: Italy
facility: Servizio Sanitario Regionale Emilia-Romagna - Istituto Scientifico Romagnolo per lo Studio e La Cura dei Tumori Srl (IRST)
city: Modena
country: Italy
facility: Azienda Ospedaliero-Universitaria di Modena (AOU Modena) - Policlinico di Modena
city: Monza
country: Italy
facility: Azienda Ospedaliera San Gerardo - Monza
city: Palermo
country: Italy
facility: La Maddalena Casa di Cura di Alta Specialita - Palermo
city: Parma
country: Italy
facility: Azienda Ospedaliero-Universitaria di Parma
city: Ravenna
country: Italy
facility: Azienda Unità Sanitaria Locale Romagna
city: Reggio Emilia
country: Italy
facility: Azienda Ospedaliera di Reggio Emilia - Arcispedale S. Maria Nuova (ASMN)
city: Roma
country: Italy
facility: IRCCS Istituti Fisioterapici Ospitalieri- Istituto Nazionale tumori Regina Elena
city: Siena
country: Italy
facility: Azienda Ospedaliera Universitaria Senese - Istituto Toscano Tumori (ITT) - Center for Immuno-Oncology (CIO)
city: Maastricht
country: Netherlands
facility: Universiteit Maastricht (UM) - Maastricht University Medical Centre (Maastricht UMC+)
city: Gdańsk
country: Poland
facility: Uniwersyteckie Centrum Kliniczne, Klinika Onkologii i Radioterapii
city: Poznań
country: Poland
facility: MED-POLONIA Sp. z o.o.
city: Przemyśl
country: Poland
facility: Wojewódzki Szpital im. św. Ojca Pio
city: Warsaw
country: Poland
facility: Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie Panstwowy
city: A Coruña
country: Spain
facility: Complejo Hospitalario Universitario A Coruña
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu i Sant Pau
city: Barcelona
country: Spain
facility: Hospital Universitari Vall d'Hebron
city: Barcelona
country: Spain
facility: Institut Catala d'Oncologia Badalona (ICO Badalona) - Hospital Germans Trias i Pujol
city: Barcelona
country: Spain
facility: Instituto Oncológico Dr Rosell Hospital Quiron Dexeus
city: Barcelona
country: Spain
facility: UOMI Cancer Center - Clinica Tres Torres
city: Girona
country: Spain
facility: Institut Catala d'Oncologia de Girona -Hospital Universitari Dr Josep Trueta
city: Jerez De La Frontera
country: Spain
facility: Hospital Universitario de Jerez
city: Madrid
country: Spain
facility: Clínica Universidad de Navarra - Madrid
city: Madrid
country: Spain
facility: Hospital HM Sanchinarro
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre
city: Madrid
country: Spain
facility: Hospital Universitario Fundación Jiménez Diaz
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
city: Málaga
country: Spain
facility: Hospital Regional Universitario de Málaga
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen de Valme
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen del Rocio
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen Macarena
city: Valencia
country: Spain
facility: Hospital Clinico Universitario de Valencia
city: Valencia
country: Spain
facility: Hospital Universitari i Politècnic La Fe
city: Ankara
country: Turkey
facility: Ankara Bilkent City Hospital Universiteler Mahallesi
city: Ankara
country: Turkey
facility: Dr. Abdurrahman Yurtaslan Ankara Oncology Training
city: Ankara
country: Turkey
facility: Gazi Universitesi Tip Fakultesi (Gazi University Faculty of Medicine) - Gazi Hastanesi (Gazi Hospital)
city: Ankara
country: Turkey
facility: Liv Hospital Ankara - Medical Oncology Clinic
city: Edirne
country: Turkey
facility: Trakya Universitesi Saglik Arastirma ve Uygulama Merkezi Hastane
city: Istanbul
country: Turkey
facility: Bezmialem University Hospital
city: Kadıköy
country: Turkey
facility: Prof. Dr. Süleyman Yalçın Şehir Hastanesi - Tibbi Onkoloji Klinigi
city: Konya
country: Turkey
facility: Necmettin Erbakan University
Study officials:
affiliation: Shanghai Pulmonary Hospital, Shanghai, China
name: Caicun Zhou
role: PRINCIPAL_INVESTIGATOR
References: