RecruitingPhase 3NCT07291037

Phase III Study of Datopotamab Deruxtecan Versus Docetaxel in Previously Treated TROP2-positive Advanced or Metastatic Non-squamous NSCLC Without Actionable Genomic Alterations

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).

Checked against the public recordLast updated Jul 1, 2026 · Source: ClinicalTrials.gov

StatusRecruiting
PhasePhase 3
U.S. locations205
SponsorAstraZeneca
01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 3
Sponsor
AstraZeneca
Interventions being studied
Drug: Datopotamab deruxtecan (Dato-DXd); Drug: Docetaxel
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

Who may be able to participate

Inclusion Criteria: * 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. Exclusion Criteria: * Squamous, mixed NSCLC, or small cell lung cancer (SCLC) histology. * NSCLC disease that is eligible for definitive local therapy alone. * History of another primary malignancy other than NSCLC, except for malignancy treated with curative intent with no known active disease within 3 years before randomisation and of low potential risk for recurrence. * Spinal cord compression or brain metastases, unless asymptomatic, stable, and not requiring treatment with corticosteroids or anticonvulsants for at least 7 days prior to randomisation. * Clinically significant corneal disease. * Has active or uncontrolled hepatitis B or C virus infection. * Known human immunodeficiency virus (HIV) infection that is not well controlled. * Uncontrolled infection requiring intravenous (IV) antibiotics, antivirals, or antifungals. * History of non-infectious interstitial lung disease (ILD)/pneumonitis including radiation pneumonitis that required steroids, has current ILD/pneumonitis, or has suspected ILD/pneumonitis that cannot be ruled out by imaging at screening. * Severe pulmonary function compromise per Investigator discretion.

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • Research SiteChandler, Arizona
  • Research SiteGilbert, Arizona
  • Research SiteGoodyear, Arizona
  • Research SiteDuarte, California
  • Research SiteIrvine, California
  • Research SiteLa Jolla, California
  • Research SiteLoma Linda, California
  • Research SiteLos Angeles, California
  • Research SiteSan Diego, California
  • Research SiteGrand Junction, Colorado
  • Research SiteWheat Ridge, Colorado
  • Research SiteNewark, Delaware

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Jul 1, 2026. Always confirm current availability with the study team.

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