Spots Global Cancer Trial Database for Study of DS-1062a in Advanced or Metastatic Non-small Cell Lung Cancer With Actionable Genomic Alterations (TROPION-Lung05)
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Trial Identification
Brief Title: Study of DS-1062a in Advanced or Metastatic Non-small Cell Lung Cancer With Actionable Genomic Alterations (TROPION-Lung05)
Official Title: Phase 2, Single-arm, Open-label Study of DS-1062a in Advanced or Metastatic Non-small Cell Lung Cancer With Actionable Genomic Alterations and Progressed On or After Applicable Targeted Therapy and Platinum Based Chemotherapy (TROPION-Lung05)
Study ID: NCT04484142
Conditions
Interventions
Study Description
Brief Summary: This is a study of the efficacy, pharmacokinetics, and safety of DS-1062a in participants with advanced or metastatic non-small cell lung cancer (NSCLC) with known actionable genomic alterations.
Detailed Description: This study will evaluate DS-1062a 6.0 mg/kg in participants with advanced or metastatic NSCLC with actionable genomic alterations and who have been previously been treated with 1 platinum-containing therapy and 1 or more lines of targeted therapy. The study will be divided into 3 periods: Screening Period, Treatment Period, and Follow-up Period. The primary analysis of Objective Response Rate (ORR) by blinded Independent Central Review (BICR) will be conducted after all participants either have been followed for at least 9 months after the start of study treatment or have discontinued from the study, whichever occurs first.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Mayo Clinic, Phoenix, Arizona, United States
University of California San Diego, La Jolla, California, United States
UCLA, Santa Monica, California, United States
Boca Raton Regional Hospital, Boca Raton, Florida, United States
Sarah Cannon Research Institute at Florida Cancer Center, North, Gainesville, Florida, United States
Mayo Clinic, Jacksonville, Florida, United States
AdventHealth Orlando, Orlando, Florida, United States
Sarah Cannon Research Institute at Florida Cancer Center, South, Port Charlotte, Florida, United States
Moffitt Cancer Center, Tampa, Florida, United States
The Office of Dr. Frederick P. Smith MD, Chevy Chase, Maryland, United States
Massachusetts General Hospital Cancer Center, Boston, Massachusetts, United States
Dana Farber Cancer Institute, Boston, Massachusetts, United States
University of Michigan, Detroit, Michigan, United States
Mayo Clinic, Rochester, Minnesota, United States
Washington University School of Medicine, Saint Louis, Missouri, United States
XCancer / Regional Cancer Care Associate (Astera), East Brunswick, New Jersey, United States
NYU Langone Medical Center, New York, New York, United States
Weill Cornell Medical College, New York, New York, United States
New York Cancer and Blood Specialists, Port Jefferson, New York, United States
University Hospitals Case Medical Center, Cleveland, Ohio, United States
Avera Cancer Institute Sioux Falls, Sioux Falls, South Dakota, United States
Sarah Cannon Research Institute at Tennessee Oncology - Chattanooga, Chattanooga, Tennessee, United States
Sarah Cannon Research Institute, Nashville, Tennessee, United States
Mary Crowley Cancer Research, Dallas, Texas, United States
University of Texas MD Anderson Cancer Center, Houston, Texas, United States
Virginia Cancer Specialists, Athens, Virginia, United States
Kadlec Clinic Hematology and Oncology, Kennewick, Washington, United States
Seattle Cancer Care Alliance, Seattle, Washington, United States
APHM - Hopital Nord, Marseille Cedex 20, Bouches-Du-Rhône, France
Gustav Roussy Cancer Campus Grand Paris, Villejuif, ile-de-France, France
University Hospital of Nantes, Nantes, Loire-Atlantique, France
CHU Toulouse Hopital Larrey, Toulouse, Occitanie, France
Centre Leon Berard, Lyon, Rhone, France
CHU Louis Pradel, Lyon, , France
Institut Curie, Paris, , France
Hopitaux Universitaire de Strasbourg- Nouvel Hopital Civil, Strasbourg, , France
Centre Hospitalier Intercommunal Toulon La Seyne sur mer Hopital Sainte-Musse, Toulon, , France
Thoraxklinik Heidelberg, Heidelberg, Baden-Württemberg, Germany
Asklepios Fachklinik Muenchen-Gauting, Gauting, Bayern, Germany
IKF Krankenhaus Nordwest, Frankfurt Am Main, Hessen, Germany
Universitaet zu Koeln - Uniklinik Koeln, Koeln, North Rhine-Westphal, Germany
Medizinische Hochschule Hannover, Hannover, , Germany
Thoraxklinik Heidelberg gGmbH, Heidelberg, , Germany
National Koranyi Institute for TB and Pulmonology, Budapest, , Hungary
Pulmonology Hospital Törökbálint, Torokbalint, , Hungary
Azienda Ospedaliera Universitaria Policlinico-OVE, Catania, CT, Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Rome, RM, Italy
University of Turin San Luigi Hospital, Orbassano, Torino, Italy
Azienda Ospedaliero-Universitaria S. Orsola Malpighi, Bologna, , Italy
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico, Milano, , Italy
Istituto Europeo di Oncologia, Milano, , Italy
Azienda Ospedaliero Universitaria di Parma, Parma, , Italy
Azienda Ospedaliera Arcispedale Santa Maria, Reggio Emilia, , Italy
Fujita Health University Hospital, Toyoake-shi, Aichi, Japan
National Cancer Center Hospital East, Kashiwa-shi, Chiba, Japan
Hokkaido Cancer Center, Sapporo-shi, Hokkaido, Japan
Kyoto University Hospital, Kyoto-shi, Kyoto, Japan
Niigata Cancer Center Hospital, Niigata-shi, Niigata, Japan
Kansai Medical University Hospital, Hirakata-shi, Osaka, Japan
Osaka City General Hospital, Osaka-shi, Osaka, Japan
Osaka International Cancer Institute, Osaka-shi, Osaka, Japan
Kindai University Hospital, Ōsaka-sayama, Osaka, Japan
Shizuoka Cancer Center, Nagaizumi-chō, Shizuoka, Japan
Tokushima University Hospital, Tokushima-shi, Tokushima, Japan
National Cancer Center Hospital, Chuo Ku, Tokyo, Japan
The Cancer Institute Hospital of JFCR, Koto-Ku, Tokyo, Japan
Aichi Cancer Center Hospital, Aichi, , Japan
Seoul National University Bundang Hospital, Seongnam, Gyeonggi-do, Korea, Republic of
Seoul National University Hospital, Seoul, , Korea, Republic of
Severance Hospital, Seoul, , Korea, Republic of
Asan Medical Center, Seoul, , Korea, Republic of
Samsung Medical Center, Seoul, , Korea, Republic of
The Netherlands Cancer Institute, Amsterdam, North Holland, Netherlands
Erasmus MC, Rotterdam, Zuid Holland, Netherlands
Hospital Universitario Puerta de Hierro de Majadahonda, Majadahonda, Madrid, Spain
Hospital Regional Universitario Malaga, Málaga, Malaga, Spain
Hospital General Universitario de Alicante, Alicante, , Spain
Hospital Universitario Vall dHebron, Barcelona, , Spain
Hospital Clinic i Provincial de Barcelona, Barcelona, , Spain
Hospital Universitario 12 de Octubre, Madrid, , Spain
National Cheng Kung University Hospital, Tainan, , Taiwan
Taipei Veterans General Hospital, Taipei City, , Taiwan
National Taiwan University Hospital NTUH, Taipei, , Taiwan
Koo Foundation Sun Yat-Sen Cancer Center, Taipei, , Taiwan
Contact Details
Name: Global Clinical Leader
Affiliation: Daiichi Sankyo
Role: STUDY_DIRECTOR
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