Phase
Condition
Non-small Cell Lung Cancer
Treatment
DZD9008
Sunvozertinib
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Aged at least 18 years old, be able to provide a signed and dated, written informedconsent.
With documented histological or cytological confirmed locally advanced or metastaticNSCLC with EGFR or HER2 mutations.
(ECOG) performance status 0-1.
Predicted life expectancy ≥ 12 weeks
Patient must have measurable disease according to RECIST 1.1.
Patients with brain metastasis (BM) can be enrolled under the condition that BM ispreviously treated and stable, neurologically asymptomatic and does not requirecorticosteroid treatment.
Adequate organ system function.
Part A Dose expansion: Dose expansion cohort 5: NSCLC patients with EGFR Exon20ins,who have not received prior systemic therapy (treatment naïve). Part B Dose extension:
Patients must have histologically or cytologically confirmed locally advanced ormetastatic NSCLC with documented EGFR Exon20ins mutation in tumor tissue from alocal CLIA-certified laboratory (or equivalent) or Sponsor designated centrallaboratory prior to the study entry.
Patients should have received at least 1 line, but no more than 3 lines of systemictherapy for metastatic/locally advanced disease.
Exclusion
Exclusion Criteria:
For part B: Patients who have received prior treatment with Poziotinib or TAK788 orother EGFR/HER2 exon20 insertion inhibitors should be excluded. Prior treatment withcurrently approved EGFR TKIs for sensitizing or T790M resistance mutations, such asgefitinib, erlotinib, osimertinib, afatinib and dacomitinb, are allowed unless thepatient had an objective response and subsequent progression assessed by theinvestigator.
Treatment with EGFR or HER2 antibodies, major surgery (excluding placement ofvascular access), or onco-immunotherapy (e.g. immune checkpoint inhibitors PD-1,PD-L1, CTLA-4) within 4 weeks before the first administration of Sunvozertinib.
Any cytotoxic chemotherapy, investigational agents or other anticancer drugs from aprevious treatment regimen or clinical study within 14 days before the firstadministration.
Radiotherapy with a limited field of radiation for palliation within 1 week of thefirst dose or with a wide field of radiation which must be completed within 4 weeksbefore the first administration.
Receiving (or unable to stop using) medications or herbal supplements known to bepotent inhibitors or inducers of CYP3A within 1-2 weeks before the firstadministration.
Any unresolved toxicities from prior therapy greater than CTCAE grade 1 at the timeof starting Sunvozertinib with the exception of alopecia and grade 2 priorplatinum-therapy related neuropathy.
Spinal cord compression or leptomeningeal metastasis.
As judged by the investigator, any evidence of severe or uncontrolled systemicdiseases, which would jeopardize compliance with the protocol, or active infectionincluding hepatitis B, hepatitis C, human immunodeficiency virus (HIV) and COVID-19 (per local practice).
Any of the following cardiac criteria: (1) Mean resting corrected QT interval (QTc) > 470 msec obtained from 3 electrocardiograms (ECGs); (2) Any clinically significantabnormalities in rhythm, conduction or morphology of resting ECG, e.g., completeleft bundle branch block, third degree heart block, and second-degree heart block,PR interval > 250 msec. (3) Any factors that increase the risk of QTF prolongation,such as heart failure, hypokalemia, congenital long QT syndrome, family history oflong QT syndrome or unexplained sudden death under 40 years of age in first degreerelatives or any concomitant medication known to prolong the QT interval; (4) Priorhistory of atrial fibrillation within 6 months of first administration ofSunvozertinib, except prior drug treatment related and recovered.
Past medical history of interstitial lung disease, drug-induced interstitial lungdisease, radiation pneumonitis which required steroid treatment, or any evidence ofclinically active interstitial lung disease.
Refractory nausea and vomiting, chronic gastrointestinal diseases, inability toswallow the formulated product or previous significant bowel resection that wouldpreclude adequate absorption of Sunvozertinib.
History of hypersensitivity to active or inactive excipients of Sunvozertinib ordrugs with a similar chemical structure or class to Sunvozertinib.
Women who are pregnant or breast feeding.
Involvement in the planning and conduct of the study.
Judgment by the investigator that the patient should not participate in the study ifthe patient is unlikely to comply with study procedures, restrictions andrequirements.
Study Design
Study Description
Connect with a study center
Fundacion Respirar - Consultorios Medicos Dr. Doreski
Cabildo,
ArgentinaSite Not Available
CEMIC Centro de Educación Médica e Investigaciones Clínicas - Hospital Universitario sede Saavedra
Ciudad Autónoma Buenos Aires,
ArgentinaSite Not Available
Centro Medico Austral OMI
Ciudad Autónoma Buenos Aires,
ArgentinaSite Not Available
Diabaid
Ciudad Autónoma Buenos Aires,
ArgentinaSite Not Available
Fundacion CENIT Para La Investigacion en Neurociencias
Ciudad Autónoma Buenos Aires,
ArgentinaSite Not Available
Instituto Argentino de Diagnositco y Tratamiento S.A.
Ciudad Autónoma Buenos Aires,
ArgentinaSite Not Available
Instituto Medico de la Fundacion de Estudios Clínicos
Ciudad Autónoma Buenos Aires,
ArgentinaSite Not Available
Centro de Investigación Pergamino SA
Pergamino,
ArgentinaSite Not Available
Clinica Viedma S.A
Viedma,
ArgentinaSite Not Available
Blacktown Hospital
Blacktown,
AustraliaSite Not Available
Chris O'Brien Lifehouse
Camperdown,
AustraliaSite Not Available
Austin Hospital
Heidelberg,
AustraliaSite Not Available
St George Hospital
Kogarah,
AustraliaSite Not Available
Peter MacCallum Cancer Centre - East Melbourne
North Melbourne,
AustraliaSite Not Available
Linear Cancer trials
Perth,
AustraliaSite Not Available
Southern Medical Day Care Centre
Wollongong,
AustraliaSite Not Available
Princess Margaret Cancer Centre
Toronto,
CanadaSite Not Available
Fundación Arturo López Pérez
Providencia,
ChileSite Not Available
Orlandi Oncología - Centro Médico Health & Care
Santiago,
ChileSite Not Available
SAGA
Santiago,
ChileSite Not Available
James Lind Centro De Investigacion Del Cancer
Temuco,
ChileSite Not Available
Beijing Cancer Hospital
Beijing,
ChinaSite Not Available
Beijing Chest Hospital,Capital Medical University
Beijing,
ChinaSite Not Available
Peking Union Medical College Hospital
Beijing,
ChinaSite Not Available
Jilin Cancer Hospital
Changchun,
ChinaSite Not Available
Hunan Cancer Hospital
Changsha,
ChinaSite Not Available
West China Hospital of Sichuan University
Chengdu,
ChinaSite Not Available
Chongqing Cancer Hospital
Chongqing,
ChinaSite Not Available
Fujian Cancer Hospital
Fuzhou,
ChinaSite Not Available
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou,
ChinaSite Not Available
The First Affiliated Hospital, Sun Yat-sen University
Guangzhou,
ChinaSite Not Available
Hainan General Hospital
Haikou,
ChinaSite Not Available
The First Affilated Hospital of Zhejiang University
Hangzhou,
ChinaSite Not Available
Zhejiang Cancer Hospital
Hangzhou,
ChinaSite Not Available
Harbin Medical University Cancer Hospital
Harbin,
ChinaSite Not Available
The Second Hospital of Anhui Medical University
Hefei,
ChinaSite Not Available
The first Affiliated Hospital of USTC Anhui Provincial Hospital
Hefei,
ChinaSite Not Available
Henan Cancer Hospital
Henan,
ChinaSite Not Available
The Affiliated Hospital of Inner Mongolia Medical University
Hohhot,
ChinaSite Not Available
The Affiliated Huaian No.1 Peoples Hospital of Nanjing Medical University
Huai'an,
ChinaSite Not Available
Jinan Central Hospital
Jinan,
ChinaSite Not Available
Linyi Cancer Hospital
Linyi,
ChinaSite Not Available
The First Affiliated Hospital of Nanchang University
Nanchang,
ChinaSite Not Available
The Second Affiliated Hospital of Nanchang University
Nanchang,
ChinaSite Not Available
Guangxi Medical University Cancer Hospital
Nanning,
ChinaSite Not Available
Zhongshan Hospital, Fudan University
Shanghai,
ChinaSite Not Available
The First Hospital of China Medical University
Shenyang,
ChinaSite Not Available
Shanxi Cancer Hospital
Taiyuan,
ChinaSite Not Available
Taizhou Hospital of Zhejiang Province
Taizhou,
ChinaSite Not Available
Tianjin Medical University Cancer Institute & Hospital
Tianjin,
ChinaSite Not Available
Hubei Cancer Hospital
Wuhan,
ChinaSite Not Available
Union Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology
Wuhan,
ChinaSite Not Available
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an,
ChinaSite Not Available
The First Affiliated Hospital of Zhengzhou University
Zhengzhou,
ChinaSite Not Available
Centre Hospitalier Universitaire d'Angers
Angers,
FranceSite Not Available
Hospices Civils de Lyon - Hôpital Louis Pradel
Bron,
FranceSite Not Available
Centre Georges François Leclerc
Dijon,
FranceSite Not Available
CHU de Lille - Institut Coeur Poumons
Hellemmes Lille,
FranceSite Not Available
Hôpital de La Timone AP-Hm
Marseille,
FranceSite Not Available
CHU de Montpellier Hôpital Arnaud de Villeneuve
Montpellier,
FranceSite Not Available
APHP-Hôpital Bichat - Claude Bernard
Paris,
FranceSite Not Available
CHU de Poitiers
Poitiers,
FranceSite Not Available
Institut de Cancérologie de l'Ouest
Saint-Herblain,
FranceSite Not Available
HIA Begin
Saint-Mandé,
FranceSite Not Available
CHU de Toulouse - Hôpital Larrey
Toulouse,
FranceSite Not Available
Institut Gustave ROUSSY
Villejuif,
FranceSite Not Available
Centro di Riferimento Oncologico (CRO)
Aviano,
ItalySite Not Available
Azienda Ospedaliero - Universitaria "Policlinico - Vittorio Emanuele"
Catania,
ItalySite Not Available
Azienda Ospedaliero-Universitaria Careggi
Firenze,
ItalySite Not Available
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori - IRST IRCCS
Meldola,
ItalySite Not Available
Istituto Europeo di Oncologia
Milano,
ItalySite Not Available
Azienda Ospedaliero-Universitaria di Parma
Parma,
ItalySite Not Available
AUSL Romagna - Ospedale S.M delle Croci
Ravenna,
ItalySite Not Available
Arcispedale Santa Maria Nuova
Reggio Emilia,
ItalySite Not Available
Istituti Fisioterapici Ospitalieri
Roma,
ItalySite Not Available
National Hospital Organization Shikoku Cancer Center
Matsuyama-shi,
JapanSite Not Available
Aichi Cancer Center Hospital
Nagoya-Shi,
JapanSite Not Available
Niigata University Medical & Dental Hospital
Niigata-Shi,
JapanSite Not Available
Okayama University Hospital
Okayama-Shi,
JapanSite Not Available
Tokushima University Hospital
Tokushima-Shi,
JapanSite Not Available
Tokyo Shinagawa Hospital
Tokyo,
JapanSite Not Available
Chungbuk National University Hospital
Cheonju,
Korea, Republic ofSite Not Available
National Cancer Center
Goyang,
Korea, Republic ofSite Not Available
Seoul National University Bundang Hospital
Seongnam,
Korea, Republic ofSite Not Available
Asan Medical Center
Seoul,
Korea, Republic ofSite Not Available
Seoul National University Hospital
Seoul,
Korea, Republic ofSite Not Available
The Catholic University of Korea, St. Vincent's Hospital
Suwon,
Korea, Republic ofSite Not Available
Hospital Sultan Ismail
Johor Bahru,
MalaysiaSite Not Available
Hospital Kuala Lumpur
Kuala Lumpur,
MalaysiaSite Not Available
University Malaya Medical Centre
Kuala Lumpur,
MalaysiaSite Not Available
Beacon Hospital
Petaling Jaya,
MalaysiaSite Not Available
Hospital Pulau Pinang
Pulau Pinang,
MalaysiaSite Not Available
Hospital Universitari Vall d'Hebrón
Barcelona,
SpainSite Not Available
Hospital de la Santa Creu i Sant Pau
Barcelona,
SpainSite Not Available
ICO (Institut Catala d'Oncologia) Badalona - Hospital Germans Trias i Pujol
Barcelona,
SpainSite Not Available
Institut Català d'Oncología de Girona - Hospital Universitari de Girona Dr. Josep Trueta
Girona,
SpainSite Not Available
Hospital de Jeréz
Jerez de la Frontera,
SpainSite Not Available
Centro Integral Oncológico Clara Campal (CIOCC)
Madrid,
SpainSite Not Available
Clínica Universidad de Navarra
Madrid,
SpainSite Not Available
Hospital Universitario 12 de Octubre
Madrid,
SpainSite Not Available
Hospital Universitario Fundacion Jimenez Diaz
Madrid,
SpainSite Not Available
Hospital Universitario La Paz
Madrid,
SpainSite Not Available
Hospital Universitario Ramón y Cajal
Madrid,
SpainSite Not Available
Hospital Regional Universitario de Malaga
Malaga,
SpainSite Not Available
Hospital Universitario Virgen Macarena
Sevilla,
SpainSite Not Available
Hospital Universitario Virgen de Valme
Sevilla,
SpainSite Not Available
Hospital La Fe
Valencia,
SpainSite Not Available
Chi Mei Hospital, Liouying
Liuying,
TaiwanSite Not Available
Taichung Veterans General Hospital
Taichung,
TaiwanSite Not Available
National Cheng Kung University Hospital
Tainan,
TaiwanSite Not Available
National Taiwan University Hospital
Taipei,
TaiwanSite Not Available
Taipei Veterans General Hospital
Taipei,
TaiwanSite Not Available
Wan Fang Hospital
Taipei,
TaiwanSite Not Available
Chang Gung Memorial Hospital
Taoyuan,
TaiwanSite Not Available
University of California, San Diego (UCSD) - Moores Cancer Center
La Jolla, California 92093
United StatesSite Not Available
University of California Irvine Medical Center (UCIMC) - Chao Family Comprehensive Cancer Center
Orange, California 92868
United StatesSite Not Available
Innovative Clinical Research Institute, LLC
Whittier, California 90603-2137
United StatesSite Not Available
University of Colorado Hospital - Anschutz Cancer Pavilion
Aurora, Colorado 80045
United StatesSite Not Available
H. Lee Moffitt Cancer Center & Research Institute
Tampa, Florida 33612
United StatesSite Not Available
Dana-Farber Cancer Institute
Boston, Massachusetts 02215
United StatesSite Not Available
Michigan Center of Medical Research
Farmington Hills, Michigan 48334
United StatesSite Not Available
Northwell Health - Centers for Advanced Medicine
New Hyde Park, New York 11042-1118
United StatesSite Not Available
Icahn School of Medicine at Mount Sinai
New York, New York 10029
United StatesSite Not Available
Laura and Isaac Perlmutter Cancer Center
New York, New York 10016
United StatesSite Not Available
The Ohio State University Comprehensive Cancer Center
Columbus, Ohio 43210-1240
United StatesSite Not Available
Virginia Cancer Specialists
Fairfax, Virginia 22031
United StatesSite Not Available
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