Spots Global Cancer Trial Database for Taletrectinib Phase 2 Global Study in ROS1 Positive NSCLC
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Trial Identification
Brief Title: Taletrectinib Phase 2 Global Study in ROS1 Positive NSCLC
Official Title: A Single-Arm, Open-Label, Multicenter Phase 2 Study to Evaluate the Efficacy and Safety of Taletrectinib in Patients With Advanced or Metastatic ROS1 Positive NSCLC and Other Solid Tumors
Study ID: NCT04919811
Conditions
Interventions
Study Description
Brief Summary: The main purpose of the study is to evaluate safety and efficacy of taletrectinib (also known as AB-106 or DS-6051b) monotherapy in the treatment of advanced NSCLC.
Detailed Description: This is a global Phase 2, multicenter, single-arm, open label study of taletrectinib in patients of NSCLC harboring with ROS1 fusion gene. About 224 patients will be enrolled and divided into 6 cohorts, depending on past history of ROS1 TKI treatment. In the cohorts open to enrollment, taletrectinib will be administered either 400mg or 600mg once daily in 21-day cycles. In one cohort, this will be in combination with carboplatin and pemetrexed both administered by IV infusion in 21-day cycles for 4 cycles. Patients will continue with the treatment on taletrectinib until progression of disease as determined by the investigator. The tumor response evaluation will be conducted on a regular basis until progression of disease. Long-term survival follow up will be conducted as well.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: Yes
Locations
Beverly Hills Cancer Center, Beverly Hills, California, United States
Moores Cancer Center at UC San Diego, La Jolla, California, United States
Keck Medicine of University of Southern California, Los Angeles, California, United States
UCI Medical Center, Orange, California, United States
PMK Medical Group Inc, Oxnard, California, United States
American Institute of Research, Whittier, California, United States
SCRI - Florida Cancer Specialists South, Fort Myers, Florida, United States
Memorial Healthcare System, Hollywood, Florida, United States
Cancer Specialists of North Florida, Jacksonville, Florida, United States
SCRI - Hematology Oncology Clinic, Baton Rouge, Louisiana, United States
Mayo Clinic, Rochester, Minnesota, United States
Center for Cancer Research, Brick, New Jersey, United States
Cleveland Clinic Foundation, Cleveland, Ohio, United States
SCRI - Tennessee Oncology, Nashville, Tennessee, United States
Renovatio Clinical, Dallas, Texas, United States
Texas Oncology, P.A., Dallas, Texas, United States
MD Anderson Cancer Center, Houston, Texas, United States
Renovatio Clinical - The Woodlands, Houston, Texas, United States
Princess Margaret Cancer Centre, Toronto, Ontario, Canada
McGill University Health Centre Research Institute, Montréal, Quebec, Canada
Hunan Cancer Hospital, Changsha, , China
West China Hospital, Chengdu, , China
Shandong Cancer Hospital, Jinan, , China
Wuhan Union Hospital, Wuhan, , China
Henan Cancer Hospital, Zhengzhou, , China
CHU Lyon - Hôpital Cardio-Vasculaire et Pneumologique Louis Pradel, Bron, , France
CHU de Grenoble - Hôpital Albert Michallon, Grenoble, , France
Centre Léon Bérard, Lyon, , France
Hôpital Nord - CHU Marseille, Marseille, , France
ICO - Site René Gauducheau, Nantes, , France
Hôpital Européen Georges Pompidou, Paris, , France
CHU Poitiers - Hopital la Miletrie, Poitiers, , France
Godinot Cancer Institute, Reims, , France
CHU Rennes - Hopital Pontchaillou, Rennes, , France
Institut Gustave Roussy, Villejuif, , France
Istituto Tumori Giovanni Paolo II IRCCS Ospedale Oncologico, Bari, , Italy
Humanitas Istituto Clinico Catanese, Misterbinanoco, Catania, , Italy
Fondazione IRCCS CA' Granda Ospedale Maggiore Policlinico, Milano, , Italy
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano, , Italy
IEO Istituto Europeo di Oncologia, Milano, , Italy
Ospedale San Raffaele, Milano, , Italy
AOU Cagliari- P.O. Policlinico Universitario Duilio Casula, Monserrato, , Italy
Azienda Ospedaliera Universitaria- Università degli Studi della Campania, Napoli, , Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Roma, , Italy
National Hospital Organization Kyushu Cancer Center, Fukuoka, , Japan
National Cancer Center Hospital East, Kashiwa, , Japan
Sendai Kousei Hospital, Miyagi, , Japan
Aichi Cancer Center Hospital, Nagoya, , Japan
Kindai University Hospital, Osaka, , Japan
Shizuoka Cancer Center, Shizuoka, , Japan
National Cancer Center Hospital, Tokyo, , Japan
The Cancer Institute Hospital of JFCR, Tokyo, , Japan
Pusan National University Hospital, Busan, , Korea, Republic of
Pusan National University Yangsan Hospital, Gyeongsang, , Korea, Republic of
Chonnam National University Hwasun Hospital, Hwasun, , Korea, Republic of
Asan Medical Center, Seoul, , Korea, Republic of
Korea University Guro Hospital, Seoul, , Korea, Republic of
Med-Polonia Sp. z o.o., Poznań, , Poland
MICS Centrum Medyczne Toruńa, Toruń, , Poland
Instytut Centrum Zdrowia Matki Polki, Łódź, , Poland
Clinica Mi Tres Torres, Barcelona, , Spain
Hospital General de Catalunya, Barcelona, , Spain
Hospital Quironsalud Barcelona, Barcelona, , Spain
Hospital Universitari Vall d'Hebron, Barcelona, , Spain
ICO l'Hospitalet - Hospital Duran i Reynals L'Hospitalet de Llobregat, Barcelona, , Spain
Hospital Universitario Clinico San Carlos, Madrid, , Spain
Hospital Universitario La Paz, Madrid, , Spain
Hospital Universitario Quironsalud Madrid, Madrid, , Spain
Hospital Universitario Ramon y Cajal, Madrid, , Spain
Hospital Regional Universitario de Malaga, Málaga, , Spain
Hospital Universitario Virgen Macarena, Sevilla, , Spain
Hospital Clinico Universitario de Valencia, Valencia, , Spain
Instituto Valenciano de Oncologia IVO, Valencia, , Spain
Contact Details
Name: Lian Li
Affiliation: AnHeart Therapeutics Inc.
Role: STUDY_DIRECTOR
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