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

Recruiting now · Phase 3

Conditions studied: Non-small Cell Lung Cancer (NSCLC)

In brief

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).

Key facts

Study ID

NCT07291037

Run by

AstraZeneca

People needed

400

Starts

2025-10-31

Expected to finish

2029-01-29

Last updated by the study team

2026-07-01

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Research Site — Chandler, Arizona, United States (enrolling)
• Research Site — South Portland, Maine, United States (enrolling)
• Research Site — Gilbert, Arizona, United States (enrolling)
• Research Site — Irvine, California, United States (enrolling)
• Research Site — Goodyear, Arizona, United States (enrolling)
• Research Site — Loma Linda, California, United States (enrolling)
• Research Site — Duarte, California, United States (enrolling)
• Research Site — San Diego, California, United States (enrolling)
• Research Site — Grand Junction, Colorado, United States (enrolling)
• Research Site — Wheat Ridge, Colorado, United States (enrolling)
• Research Site — Newark, Delaware, United States (enrolling)
• Research Site — La Jolla, California, United States (enrolling)
• Research Site — Fort Myers, Florida, United States (enrolling)
• Research Site — Jacksonville, Florida, United States (enrolling)
• Research Site — St. Petersburg, Florida, United States (enrolling)
• Research Site — Tampa, Florida, United States (enrolling)
• Research Site — West Palm Beach, Florida, United States (enrolling)
• Research Site — Marietta, Georgia, United States (enrolling)
• Research Site — Newnan, Georgia, United States (enrolling)
• Research Site — Chicago, Illinois, United States (enrolling)
• Research Site — Chicago, Illinois, United States (enrolling)
• Research Site — Niles, Illinois, United States (enrolling)
• Research Site — Zion, Illinois, United States (enrolling)
• Research Site — Louisville, Kentucky, United States (enrolling)
• Research Site — Baltimore, Maryland, United States (enrolling)

Full record on ClinicalTrials.gov

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