Spots Global Cancer Trial Database for Assessing an Oral EGFR Inhibitor, Sunvozertinib in Patients Who Have Advanced Non-small Cell Lung Cancer With EGFR or HER2 Mutation (WU-KONG1)
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Trial Identification
Brief Title: Assessing an Oral EGFR Inhibitor, Sunvozertinib in Patients Who Have Advanced Non-small Cell Lung Cancer With EGFR or HER2 Mutation (WU-KONG1)
Official Title: A Phase I/II, Open-Label, Multicenter Study to Assess the Safety, Tolerability, Pharmacokinetics and Anti-tumor Efficacy of DZD9008 in Patients With Advanced Non-Small Cell Lung Cancer (NSCLC) With EGFR or HER2 Mutation
Study ID: NCT03974022
Conditions
Interventions
Study Description
Brief Summary: This study will treat patients with advanced NSCLC with EGFR or HER2 mutation who have progressed following prior therapy. This is the first time this drug is tested in patients, and so it will help to understand what type of side effects may occur with the drug treatment. It will also measure the levels of drug in the body and preliminarily assess its anti-cancer activity as monotherapy.
Detailed Description: A Phase I/II, Open-Label, Multicenter Study to Assess the Safety, Tolerability, Pharmacokinetics and Anti-tumor Efficacy of Sunvozertinib in Patients with Advanced Non-Small Cell Lung Cancer (NSCLC) with EGFR or HER2 mutation. This study includes dose escalation, dose expansion, food effect (Part A) and dose extension (Part B).
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
University of California, San Diego (UCSD) - Moores Cancer Center, La Jolla, California, United States
University of California Irvine Medical Center (UCIMC) - Chao Family Comprehensive Cancer Center, Orange, California, United States
Innovative Clinical Research Institute, LLC, Whittier, California, United States
University of Colorado Hospital - Anschutz Cancer Pavilion, Aurora, Colorado, United States
H. Lee Moffitt Cancer Center & Research Institute, Tampa, Florida, United States
Dana-Farber Cancer Institute, Boston, Massachusetts, United States
Michigan Center of Medical Research, Farmington Hills, Michigan, United States
Northwell Health - Centers for Advanced Medicine, New Hyde Park, New York, United States
Laura and Isaac Perlmutter Cancer Center, New York, New York, United States
Icahn School of Medicine at Mount Sinai, New York, New York, United States
The Ohio State University Comprehensive Cancer Center, Columbus, Ohio, United States
Virginia Cancer Specialists, Fairfax, Virginia, United States
Fundacion Respirar - Consultorios Medicos Dr. Doreski, Cabildo, , Argentina
CEMIC Centro de Educación Médica e Investigaciones Clínicas - Hospital Universitario sede Saavedra, Ciudad Autónoma Buenos Aires, , Argentina
Centro Medico Austral OMI, Ciudad Autónoma Buenos Aires, , Argentina
Diabaid, Ciudad Autónoma Buenos Aires, , Argentina
Fundacion CENIT Para La Investigacion en Neurociencias, Ciudad Autónoma Buenos Aires, , Argentina
Instituto Argentino de Diagnositco y Tratamiento S.A., Ciudad Autónoma Buenos Aires, , Argentina
Instituto Medico de la Fundacion de Estudios Clínicos, Ciudad Autónoma Buenos Aires, , Argentina
Centro de Investigación Pergamino SA, Pergamino, , Argentina
Clinica Viedma S.A, Viedma, , Argentina
Blacktown Hospital, Blacktown, , Australia
Chris O'Brien Lifehouse, Camperdown, , Australia
Austin Hospital, Heidelberg, , Australia
St George Hospital, Kogarah, , Australia
Peter MacCallum Cancer Centre - East Melbourne, North Melbourne, , Australia
Linear Cancer trials, Perth, , Australia
Southern Medical Day Care Centre, Wollongong, , Australia
Princess Margaret Cancer Centre, Toronto, , Canada
Fundación Arturo López Pérez, Providencia, , Chile
Orlandi Oncología - Centro Médico Health & Care, Santiago, , Chile
SAGA, Santiago, , Chile
James Lind Centro De Investigacion Del Cancer, Temuco, , Chile
Beijing Cancer Hospital, Beijing, , China
Beijing Chest Hospital，Capital Medical University, Beijing, , China
Peking Union Medical College Hospital, Beijing, , China
Jilin Cancer Hospital, Changchun, , China
Hunan Cancer Hospital, Changsha, , China
West China Hospital of Sichuan University, Chengdu, , China
Chongqing Cancer Hospital, Chongqing, , China
Fujian Cancer Hospital, Fuzhou, , China
The First Affiliated Hospital of Guangzhou Medical University, Guangzhou, , China
The First Affiliated Hospital, Sun Yat-sen University, Guangzhou, , China
Hainan General Hospital, Haikou, , China
The First Affilated Hospital of Zhejiang University, Hangzhou, , China
Zhejiang Cancer Hospital, Hangzhou, , China
Harbin Medical University Cancer Hospital, Harbin, , China
The first Affiliated Hospital of USTC Anhui Provincial Hospital, Hefei, , China
The Second Hospital of Anhui Medical University, Hefei, , China
Henan Cancer Hospital, Henan, , China
The Affiliated Hospital of Inner Mongolia Medical University, Hohhot, , China
The Affiliated Huaian No.1 Peoples Hospital of Nanjing Medical University, Huai'an, , China
Jinan Central Hospital, Jinan, , China
Linyi Cancer Hospital, Linyi, , China
The First Affiliated Hospital of Nanchang University, Nanchang, , China
The Second Affiliated Hospital of Nanchang University, Nanchang, , China
Guangxi Medical University Cancer Hospital, Nanning, , China
Zhongshan Hospital, Fudan University, Shanghai, , China
The First Hospital of China Medical University, Shenyang, , China
Shanxi Cancer Hospital, Taiyuan, , China
Taizhou Hospital of Zhejiang Province, Taizhou, , China
Tianjin Medical University Cancer Institute & Hospital, Tianjin, , China
Hubei Cancer Hospital, Wuhan, , China
Union Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology, Wuhan, , China
The First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, , China
The First Affiliated Hospital of Zhengzhou University, Zhengzhou, , China
Centre Hospitalier Universitaire d'Angers, Angers, , France
Hospices Civils de Lyon - Hôpital Louis Pradel, Bron, , France
Centre Georges François Leclerc, Dijon, , France
CHU de Lille - Institut Coeur Poumons, Hellemmes Lille, , France
Hôpital de La Timone AP-Hm, Marseille, , France
CHU de Montpellier Hôpital Arnaud de Villeneuve, Montpellier, , France
APHP-Hôpital Bichat - Claude Bernard, Paris, , France
CHU de Poitiers, Poitiers, , France
Institut de Cancérologie de l'Ouest, Saint-Herblain, , France
HIA Begin, Saint-Mandé, , France
CHU de Toulouse - Hôpital Larrey, Toulouse, , France
Institut Gustave ROUSSY, Villejuif, , France
Centro di Riferimento Oncologico (CRO), Aviano, , Italy
Azienda Ospedaliero - Universitaria "Policlinico - Vittorio Emanuele", Catania, , Italy
Azienda Ospedaliero-Universitaria Careggi, Firenze, , Italy
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori - IRST IRCCS, Meldola, , Italy
Istituto Europeo di Oncologia, Milano, , Italy
Azienda Ospedaliero-Universitaria di Parma, Parma, , Italy
AUSL Romagna - Ospedale S.M delle Croci, Ravenna, , Italy
Arcispedale Santa Maria Nuova, Reggio Emilia, , Italy
Istituti Fisioterapici Ospitalieri, Roma, , Italy
National Hospital Organization Shikoku Cancer Center, Matsuyama-shi, , Japan
Aichi Cancer Center Hospital, Nagoya-Shi, , Japan
Niigata University Medical & Dental Hospital, Niigata-Shi, , Japan
Okayama University Hospital, Okayama-Shi, , Japan
Tokushima University Hospital, Tokushima-Shi, , Japan
Tokyo Shinagawa Hospital, Tokyo, , Japan
Chungbuk National University Hospital, Cheonju, , Korea, Republic of
National Cancer Center, Goyang, , Korea, Republic of
Seoul National University Bundang Hospital, Seongnam, , Korea, Republic of
Asan Medical Center, Seoul, , Korea, Republic of
Seoul National University Hospital, Seoul, , Korea, Republic of
The Catholic University of Korea, St. Vincent's Hospital, Suwon, , Korea, Republic of
Hospital Sultan Ismail, Johor Bahru, , Malaysia
Hospital Kuala Lumpur, Kuala Lumpur, , Malaysia
University Malaya Medical Centre, Kuala Lumpur, , Malaysia
Hospital de la Santa Creu i Sant Pau, Barcelona, , Spain
Hospital Universitari Vall d'Hebrón, Barcelona, , Spain
ICO (Institut Catala d'Oncologia) Badalona - Hospital Germans Trias i Pujol, Barcelona, , Spain
Institut Català d'Oncología de Girona - Hospital Universitari de Girona Dr. Josep Trueta, Girona, , Spain
Hospital de Jeréz, Jerez de la Frontera, , Spain
Centro Integral Oncológico Clara Campal (CIOCC), Madrid, , Spain
Clínica Universidad de Navarra, Madrid, , Spain
Hospital Universitario 12 de Octubre, Madrid, , Spain
Hospital Universitario Fundacion Jimenez Diaz, Madrid, , Spain
Hospital Universitario La Paz, Madrid, , Spain
Hospital Universitario Ramón y Cajal, Madrid, , Spain
Hospital Regional Universitario de Malaga, Malaga, , Spain
Hospital Universitario Virgen de Valme, Sevilla, , Spain
Hospital Universitario Virgen Macarena, Sevilla, , Spain
Hospital La Fe, Valencia, , Spain
Chi Mei Hospital, Liouying, Liuying, , Taiwan
Taichung Veterans General Hospital, Taichung, , Taiwan
National Cheng Kung University Hospital, Tainan, , Taiwan
National Taiwan University Hospital, Taipei, , Taiwan
Taipei Veterans General Hospital, Taipei, , Taiwan
Wan Fang Hospital, Taipei, , Taiwan
Chang Gung Memorial Hospital, Taoyuan, , Taiwan
Contact Details
Name: Pasi Antero Jänne, M.D & Ph. D
Affiliation: Dana-Farber Cancer Institute
Role: PRINCIPAL_INVESTIGATOR
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