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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

Interventions

Sunvozertinib

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

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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