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).
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
400
Dato-DXd administered intravenously (IV)
Docetaxel administered intravenously (IV)
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
Objective response rate (ORR)
ORR is defined as the proportion of participants who have a confirmed complete response (CR) or confirmed partial response (PR), as determined by Blinded Independent Central Review (BICR) per Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST 1.1).
Time frame: Approximately 2.5 years
Duration of response (DoR)
DoR is defined as the time from the date of first documented response until the date of documented 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
Time to second progression or death (PFS2)
PFS2 is defined as the time from randomization until the earliest of the progression event (following the initial progression event), after first subsequent therapy, or death. The date of the second progression will be recorded by the Investigator in the electronic Case Report Form (eCRF) and defined according to local standard clinical practice based on radiological or clinical progression.
Time frame: Approximately 2.5 years
Participant-reported lung cancer symptoms of non-small cell lung cancer (NSCLC)
AstraZeneca Clinical Study Information Center
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Research Site
Chandler, Arizona, United States
RECRUITINGResearch Site
Gilbert, Arizona, United States
RECRUITINGResearch Site
Goodyear, Arizona, United States
RECRUITINGResearch Site
Duarte, California, United States
RECRUITINGResearch Site
Irvine, California, United States
RECRUITINGResearch Site
La Jolla, California, United States
RECRUITINGResearch Site
Loma Linda, California, United States
RECRUITINGResearch Site
Los Angeles, California, United States
RECRUITINGResearch Site
San Diego, California, United States
RECRUITINGResearch Site
Grand Junction, Colorado, United States
RECRUITING...and 196 more locations
Time to deterioration (TTD) in pulmonary symptoms (dyspnoea, cough, and chest pain). TTD is defined as time from randomization to the date of first deterioration. Deterioration is defined as change from baseline that reaches an meaningful change threshold (MCT).
Time frame: Approximately 2.5 years
Participant-reported physical functioning
Time to deterioration (TTD) in physical functioning. TTD is defined as time from randomization to the date of first deterioration. Deterioration is defined as change from baseline that reaches a meaningful change threshold (MCT).
Time frame: Approximately 2.5 years
Participant-reported global health status (GHS)/quality of life (QoL)
Time to deterioration (TTD) in GHS/QoL. TTD is defined as time from the date of randomisation to the date of first deterioration. Deterioration is defined as change from baseline that reaches a meaningful change threshold (MCT)
Time frame: Approximately 2.5 years
Diagnostic development and biomarker assay concordance analysis
Evaluate the relationship between TROP2 NMR status at a defined cutoff and efficacy endpoints, as determined by the diagnostic device.
Time frame: Approximately 2.5 years