A Phase III, Randomised, Open-Label, Multicentre Study of Datopotamab Deruxtecan or Docetaxel in Previously Treated TROP2-positive Advanced or Metastatic Non-squamous Non-Small Cell Lung Cancer Without Actionable Genomic Alterations (TROPION-Lung17)
Summary
TROPION-Lung17 will measure the efficacy and safety of datopotamab deruxtecan (Dato-DXd) compared with docetaxel in patients with trophoblast cell surface protein 2 (TROP2) positive advanced or metastatic lung cancer without actionable genomic alterations (AGA).
Detailed description
TROPION-Lung17 is a phase III, 2-arm, randomised, open-label, multicentre study, assessing the efficacy and safety of Dato-DXd compared with docetaxel in participants with previously treated trophoblast cell surface protein 2 (TROP2) normalised membrane ratio (NMR) positive advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) without actionable genomic alterations (AGA), and to assess the clinical performance of the investigational in vitro diagnostic (IVD) device.
Arms & interventions
- DrugDatopotamab deruxtecan (Dato-DXd)
Dato-DXd administered intravenously (IV)
- DrugDocetaxel
Docetaxel administered intravenously (IV)
Outcome measures
Primary
Progression-free survival (PFS)
PFS is defined as the time from randomization until radiological progression per Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST 1.1) as assessed by Blinded Independent Central Review (BICR), or death due to any cause.
Time frame: Approximately 2.5 years
Overall survival (OS)
OS is defined as the time from randomization until the date of death due to any cause.
Time frame: Approximately 3.5 years
Secondary
Objective response rate (ORR)
Time frame: Approximately 2.5 years
Duration of response (DoR)
Time frame: Approximately 2.5 years
Time to second progression or death (PFS2)
Time frame: Approximately 2.5 years
Exposure-efficacy relationship
Time frame: Approximately 2.5 years
Exposure-safety relationship
Time frame: Approximately 2.5 years
Covariates effect on exposure
Time frame: Approximately 2.5 years
Immunogenicity of datopotamab deruxtecan (Dato-DXd)
Time frame: Approximately 2.5 years
Participant-reported lung cancer symptoms of non-small cell lung cancer (NSCLC)
Time frame: Approximately 2.5 years
Participant-reported physical functioning
Time frame: Approximately 2.5 years
Participant-reported global health status (GHS)/quality of life (QoL)
Time frame: Approximately 2.5 years
Correlation of TROP2 expression at various cut offs with clinical response
Time frame: Approximately 2.5 years
Diagnostic development and biomarker assay concordance analysis
Time frame: Approximately 2.5 years
Eligibility criteria
Study locations (50)
Research Site
Chandler, Arizona, 85224
Research Site
Gilbert, Arizona, 85234
Research Site
Goodyear, Arizona, 85338
Research Site
Duarte, California, 91010
Research Site
Irvine, California, 92618
Research Site
La Jolla, California, 92093
Research Site
Loma Linda, California, 92350
Research Site
Los Angeles, California, 90095
Research Site
San Diego, California, 92123
Research Site
Grand Junction, Colorado, 81501
Research Site
Wheat Ridge, Colorado, 80033
Research Site
Newark, Delaware, 19713
Research Site
Washington D.C., District of Columbia, 20037
Research Site
Fort Myers, Florida, 33901
Research Site
Jacksonville, Florida, 32224
Research Site
St. Petersburg, Florida, 33709
Research Site
Tampa, Florida, 33612
Research Site
West Palm Beach, Florida, 33401
Research Site
Marietta, Georgia, 30060
Research Site
Newnan, Georgia, 30265
Research Site
Chicago, Illinois, 60612
Research Site
Chicago, Illinois, 60637
Research Site
Niles, Illinois, 60714
Research Site
Zion, Illinois, 60099
Research Site
Louisville, Kentucky, 40207
Research Site
South Portland, Maine, 04106
Research Site
Baltimore, Maryland, 21201
Research Site
Brandywine, Maryland, 20613
Research Site
Boston, Massachusetts, 02215
Research Site
Detroit, Michigan, 48202
Research Site
Rochester, Minnesota, 55905
Research Site
Bridgeton, Missouri, 63044
Research Site
Columbia, Missouri, 65212
Research Site
Lincoln, Nebraska, 68516
Research Site
Albuquerque, New Mexico, 87109
Research Site
East Syracuse, New York, 13057
Research Site
Portland, Oregon, 97239
Research Site
Hershey, Pennsylvania, 17033
Research Site
Philadelphia, Pennsylvania, 19104
Research Site
Greenville, South Carolina, 29607
Research Site
Memphis, Tennessee, 38120
Research Site
Austin, Texas, 78745
Research Site
Denton, Texas, 76201
Research Site
Plano, Texas, 75075
Research Site
Charlottesville, Virginia, 22908
Research Site
Fairfax, Virginia, 22031
Research Site
Williamsburg, Virginia, 23188
Research Site
Tacoma, Washington, 98405
Research Site
Morgantown, West Virginia, 26506
Research Site
Eau Claire, Wisconsin, 54703