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Purpose

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).

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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.

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Arm A: Datopotamab deruxtecan monotherapy Arm B: Docetaxel monotherapy
Primary Purpose
Treatment
Masking
None (Open Label)
Masking Description
TROPION-Lung17 is an open-label study; however, the study will be conducted as 'Sponsor-blind'.

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Arm A: Datopotamab deruxtecan (Dato-DXd) monotherapy 		Participants in the Dato-DXd monotherapy group will receive Dato-DXd as intravenous (IV) infusion every 3 weeks (Q3W) on Day 1 of each 21-day cycle.
  • Drug: Datopotamab deruxtecan (Dato-DXd)
    Dato-DXd administered intravenously (IV)
    Other names:
    • DS-1062a
Active Comparator
Arm B: Docetaxel monotherapy 		Participants in the docetaxel monotherapy group will receive docetaxel as intravenous (IV) infusion every 3 weeks (Q3W) on Day 1 of each 21-day cycle.
  • Drug: Docetaxel
    Docetaxel administered intravenously (IV)

Recruiting Locations

Research Site
Chandler, Arizona 85224

Research Site
Gilbert, Arizona 85234

Research Site
Goodyear, Arizona 85338

Research Site
Duarte, California 91010

Research Site
Irvine, California 92618

Research Site
La Jolla, California 92093

Research Site
Loma Linda, California 92350

Research Site
San Diego, California 92123

Research Site
Grand Junction, Colorado 81501

Research Site
Wheat Ridge, Colorado 80033

Research Site
Newark, Delaware 19713

Research Site
Fort Myers, Florida 33901

Research Site
Jacksonville, Florida 32224

Research Site
St. Petersburg, Florida 33709

Research Site
Tampa, Florida 33612

Research Site
West Palm Beach, Florida 33401

Research Site
Marietta, Georgia 30060

Research Site
Newnan, Georgia 30265

Research Site
Chicago, Illinois 60612

Research Site
Chicago, Illinois 60637

Research Site
Niles, Illinois 60714

Research Site
Zion, Illinois 60099

Research Site
Louisville, Kentucky 40207

Research Site
South Portland, Maine 04106

Research Site
Baltimore, Maryland 21201

Research Site
Brandywine, Maryland 20613

Research Site
Boston, Massachusetts 02215

Research Site
Detroit, Michigan 48202

Research Site
Rochester, Minnesota 55905

Research Site
Bridgeton, Missouri 63044

Research Site
Lincoln, Nebraska 68516

Research Site
Albuquerque, New Mexico 87109

Research Site
East Syracuse, New York 13057

Research Site
Hershey, Pennsylvania 17033

Research Site
Lancaster, Pennsylvania 17601

Research Site
Greenville, South Carolina 29607

Research Site
Memphis, Tennessee 38120

Research Site
Austin, Texas 78745

Research Site
Denton, Texas 76201

Research Site
Plano, Texas 75075

Research Site
Charlottesville, Virginia 22908

Research Site
Fairfax, Virginia 22031

Research Site
Williamsburg, Virginia 23188

Research Site
Tacoma, Washington 98405

Research Site
Morgantown, West Virginia 26506

Research Site
Eau Claire, Wisconsin 54703

More Details

Status
Recruiting
Sponsor
AstraZeneca

Study Contact

AstraZeneca Clinical Study Information Center
1-877-240-9479
information.center@astrazeneca.com

Detailed 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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.