A Phase III Study of Datopotamab Deruxtecan or Docetaxel in Previously Treated Trop2-Positive Advanced or Metastatic Non-Squamous NSCLC Without Actionable Genomic Alterations

Clinical Trial Title A Phase III, Randomized, 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)

National Clinical Trial Number: NCT07291037

Clinical Trial Protocol 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.

Clinical Trial Eligibility Criteria:

In order to participate you must meet the following criteria:

Have 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.
Have documentation of radiographic disease progression while on or after receiving the most recent treatment regimen for advanced or metastatic NSCLC.
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.

You will be excluded from the study if any of the following criteria apply to you:

Have squamous, mixed NSCLC, or small cell lung cancer (SCLC) histology.
Have NSCLC disease that is eligible for definitive local therapy alone.
Have a history of another primary malignancy other than NSCLC, except for malignancy treated with curative intent with no known active disease within 3 years before randomization and of low potential risk for recurrence.
Have spinal cord compression or brain metastases, unless asymptomatic, stable, and not requiring treatment with corticosteroids or anticonvulsants for at least 7 days prior to randomization.

This is a partial list of eligibility requirements. To inquire about your eligibility, please call the contact number provided. If you wish to inquire via email, please include the title of the study in your message.