Phase III Study of Datopotamab Deruxtecan Versus Docetaxel in Previously Treated TROP2-positive Advanced or Metastatic Non-squamous NSCLC Without Actionable Genomic Alterations
Lung Cancer
Unknown Primary
18 Years and older, Male and Female
D763QC00001 (primary)
NCI-2025-09447
2024-520101-39-00
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).
Objectives
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.
Eligibility
- Pathologically documented Stage IIIB, IIIC, or Stage IV non-squamous non-small cell lung cancer (NSCLC) without actionable genomic alterations (AGA) at the time of randomisation and meets the criteria for NSCLC:
- Participants must have documented negative test results for epidermal growth factor receptor (EGFR), anaplastic lymphoma kinase (ALK), and ROS proto-oncogene 1 (ROS1) genomic alterations.
- Has no known tumour genomic alterations in neurotrophic tyrosine receptor kinase (NTRK), proto-oncogene B-raf (BRAF), rearranged during transfection (RET), mesenchymal-epithelial transition (MET) exon 14 skipping, Kirsten rat sarcoma viral oncogene homolog (KRAS) G12C, human epidermal growth factor receptor 2 (HER2) or any other actionable driver oncogenes for which there are locally approved and available targeted first-line therapies.
- Prospectively assessed trophoblast cell surface protein 2 (TROP2) normalised membrane ratio (NMR) positive.
- Documentation of radiographic disease progression while on or after receiving the most recent treatment regimen for advanced or metastatic NSCLC.
- Participants must have received platinum based chemotherapy (PBC) in combination with anti-programmed death-protein 1 (anti-PD-1)/anti-programmed death-ligand 1 (anti-PD-L1) monoclonal antibody (mAb) as the only prior line of therapy or received PBC and anti-PD-1/anti-PD-L1 monoclonal antibody (in either order) sequentially as the only 2 prior lines of therapy.
- Provision of acceptable formalin fixed and paraffin embedded (FFPE) tumour sample for assessment of TROP2.
- At least one lesion not previously irradiated that qualifies as a Response Evaluation Criteria in Solid Tumours, Version 1.1 (RECIST 1.1) target lesion (TL) at baseline and can be accurately measured at baseline as = 10 mm in the longest diameter (except lymph nodes, which must have short axis = 15 mm) with computed tomography (CT) or magnetic resonance imaging (MRI) and is suitable for accurate repeated measurements.
- Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 or 1.
- Adequate bone marrow reserve and organ function within 7 days before randomisation.
Treatment Sites in Georgia
144 Bill Carruth Parkway
Suite 3100
Hiram, GA 30141
770-281-5131
www.ngoc.com
6002 Professional Parkway
Suite 140
Douglasville, GA 30134
770-281-5101
www.ngoc.com
157 Clinic Avenue
Suite 202
Carrollton, GA 30117
770-281-5101
www.ngoc.com
340 Kennestone Hospital Blvd.
Suite 100
Marietta, GA 30060
770-281-5101
**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts...
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