Spots Global Cancer Trial Database for Phase III Study of AK112 for NSCLC Patients
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Trial Identification
Brief Title: Phase III Study of AK112 for NSCLC Patients
Official Title: A Randomized, Double-blind, Multi-center, Phase III Study of AK112 or Placebo Combined With Pemetrexed and Carboplatin in Patients With EGFR-mutant Locally Advanced or Metastatic Non-squamous NSCLC Who Have Failed to EGFR-TKI Treatment
Study ID: NCT06396065
Conditions
Study Description
Brief Summary: A Randomized, Double-blind, Multi-center, Phase III Clinical Study of AK112 or Placebo Combined With Pemetrexed and Carboplatin in Patients With EGFR-mutant Locally Advanced or Metastatic Non-squamous Non-small Cell Lung Cancer Who Have Progressed on or Following Growth Factor Receptor Tyrosine Kinase Inhibitor (EGFR-TKI) Treatment (HARMONi)
Detailed Description: The trial will be performed as a randomized, Double-Blind, Multicenter trial to compare Ivonescimab (SMT112 /AK112) Plus Pemetrexed and Carboplatin to Placebo Plus Pemetrexed and Carboplatin in Patients with Locally Advanced or Metastatic Non-Squamous Non-Small Cell Lung Cancer (NSCLC) Harboring. Approximately 420 subjects will be randomized to two treatment arms at the ratio of 1:1. Each enrolled subject will receive an intravenous infusion of the Ivonescimab (SMT112 /AK112)/Placebo Plus Pemetrexed and Carboplatin (Q3W,up to 4 cycles) in treatment periods per the randomization schedule. Afterward, Ivonescimab (SMT112 /AK112)/ Placebo Plus Pemetrexed will be used for maintenance treatment (administered on Day 1 of each cycle, Q3W) up to 2 years.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: Yes
Locations
CBCC Global Research, Bakersfield, California, United States
UC San Diego, La Jolla, California, United States
University of Southern California, Los Angeles, California, United States
Valkyrie Clinical Trials, Los Angeles, California, United States
UCLA Department of Medicine - Hematology/Oncology, Los Angeles, California, United States
Palo Alto Medical Foundation Research Institute, Mountain View, California, United States
Providence St. Joseph, Orange, California, United States
UC Irvine, Orange, California, United States
Sutter Cancer center, Sacramento, California, United States
UC DAVIS Comprehensive Cancer Center, Sacramento, California, United States
California Pacific Medical Center, San Francisco, California, United States
Providence Medical Foundation, Santa Rosa, California, United States
Presbyterian Intercommunity Hospital, Whittier, California, United States
Rocky Mountain Cancer Center, Lone Tree, Colorado, United States
University of Miami, Miami, Florida, United States
Florida Cancer Associates - Ocala Oncology, Ocala, Florida, United States
BRCR Global, Plantation, Florida, United States
Florida Cancer Specialists - North, Saint Petersburg, Florida, United States
BRCR Global, Tamarac, Florida, United States
Florida Cancer Specialists -East, West Palm Beach, Florida, United States
Hematology/Oncology Clinic - SCRI, Baton Rouge, Louisiana, United States
New England Cancer Specialists, Scarborough, Maine, United States
American Oncology Partners, Bethesda, Maryland, United States
Dana Farber Cancer Institute, Boston, Massachusetts, United States
HealthPartners Cancer Research Center, Saint Paul, Minnesota, United States
New York Oncology/Hematology, Albany, New York, United States
NYU Langone Laura and Isaac Perlmutter Cancer Center, New York, New York, United States
Sanford Roger Maris Cancer Center, Fargo, North Dakota, United States
Zangmeister Cancer Center, Columbus, Ohio, United States
Oncology Hematology Care, Fairfield, Ohio, United States
Williamette Valley Cancer Institute and Research, Eugene, Oregon, United States
Kaiser Permanente Northwest, Portland, Oregon, United States
Medical University South Carolina, Charleston, South Carolina, United States
Texas Oncology South Austin, Austin, Texas, United States
Texas Oncology Baylor Charles A. Sammons Cancer Center, Dallas, Texas, United States
MD Anderson University of Texas, Houston, Texas, United States
Texas Oncology Webster, Webster, Texas, United States
Virginia Cancer specialisits, Fairfax, Virginia, United States
Compass Oncology, Vancouver, Washington, United States
Cross cancer Institute, Edmonton, Alberta, Canada
BC Cancer, Vancouver, British Columbia, Canada
Lung Cancer Canada, Ottawa, Ontario, Canada
Princess Margaret Cancer Centre, Toronto, Ontario, Canada
Allan Blaire Cancer Centre, Regina, Saskatchewan, Canada
Universite Hospital Laval, Québec, , Canada
CHI Creteil, Creteil, , France
Hospital Bichat-Claude Bernard, Paris, , France
Institut Curie, Paris, , France
Campus Bio-Medico University, Roma, , Italy
Istituto Nazionale Tumori Regina Elena, Roma, , Italy
Vall d'Hebron Institute of Oncology, Barcelona, , Spain
Badalona-Hospital Germans Trias i Pujol, Barcelona, , Spain
Hospital Teresa Herrera, Coruña, , Spain
omplejo Hospitalario Universitario Insular-Materno Infantil de Gran Canaria, Las Palmas, , Spain
Lucus Augusti University Hospital, Lugo, , Spain
Hospital General Universitario Gregorio Maranon, Madrid, , Spain
Hospital Universitario Ramon y Cajal, Madrid, , Spain
Hospital Universitario Clinico San Carlos, Madrid, , Spain
Instituto de Investigacion Sanitaria-Fundacion Jimenez Diaz, Madrid, , Spain
Hospital Universitario La Paz, Madrid, , Spain
Puerta de Hierro University Hospital, Majadahonda, , Spain
Hospital Regional Universitario de Malaga, Malaga, , Spain
Hospital Universitario Nuestro Senora de Valme, Sevilla, , Spain
Contact Details
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