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
A Phase III, Randomised, 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)
2 other identifiers
interventional
400
20 countries
199
Brief 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Oct 2025
Typical duration for phase_3
199 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 28, 2025
CompletedStudy Start
First participant enrolled
October 31, 2025
CompletedFirst Posted
Study publicly available on registry
December 18, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 29, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
January 29, 2029
April 29, 2026
April 1, 2026
3.2 years
October 28, 2025
April 28, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Progression-free survival (PFS)
PFS is defined as the time from randomization until radiological progression per Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST 1.1) as assessed by Blinded Independent Central Review (BICR), or death due to any cause.
Approximately 2.5 years
Overall survival (OS)
OS is defined as the time from randomization until the date of death due to any cause.
Approximately 3.5 years
Secondary Outcomes (12)
Objective response rate (ORR)
Approximately 2.5 years
Duration of response (DoR)
Approximately 2.5 years
Time to second progression or death (PFS2)
Approximately 2.5 years
Exposure-efficacy relationship
Approximately 2.5 years
Exposure-safety relationship
Approximately 2.5 years
- +7 more secondary outcomes
Study Arms (2)
Arm A: Datopotamab deruxtecan (Dato-DXd) monotherapy
EXPERIMENTALParticipants 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.
Arm B: Docetaxel monotherapy
ACTIVE COMPARATORParticipants in the docetaxel monotherapy group will receive docetaxel as intravenous (IV) infusion every 3 weeks (Q3W) on Day 1 of each 21-day cycle.
Interventions
Dato-DXd administered intravenously (IV)
Eligibility Criteria
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
- Daiichi Sankyocollaborator
Study Sites (204)
Research Site
Chandler, Arizona, 85224, United States
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Gilbert, Arizona, 85234, United States
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Goodyear, Arizona, 85338, United States
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Duarte, California, 91010, United States
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Irvine, California, 92618, United States
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La Jolla, California, 92093, United States
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Loma Linda, California, 92350, United States
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Los Angeles, California, 90095, United States
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San Diego, California, 92123, United States
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Grand Junction, Colorado, 81501, United States
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Wheat Ridge, Colorado, 80033, United States
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Newark, Delaware, 19713, United States
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Washington D.C., District of Columbia, 20037, United States
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Fort Myers, Florida, 33901, United States
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Jacksonville, Florida, 32224, United States
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St. Petersburg, Florida, 33709, United States
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Tampa, Florida, 33612, United States
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West Palm Beach, Florida, 33401, United States
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Marietta, Georgia, 30060, United States
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Newnan, Georgia, 30265, United States
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Chicago, Illinois, 60612, United States
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Chicago, Illinois, 60637, United States
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Niles, Illinois, 60714, United States
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Zion, Illinois, 60099, United States
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Louisville, Kentucky, 40207, United States
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South Portland, Maine, 04106, United States
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Baltimore, Maryland, 21201, United States
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Brandywine, Maryland, 20613, United States
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Boston, Massachusetts, 02215, United States
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Detroit, Michigan, 48202, United States
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Rochester, Minnesota, 55905, United States
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Bridgeton, Missouri, 63044, United States
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Columbia, Missouri, 65212, United States
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Lincoln, Nebraska, 68516, United States
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Albuquerque, New Mexico, 87109, United States
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East Syracuse, New York, 13057, United States
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Portland, Oregon, 97239, United States
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Hershey, Pennsylvania, 17033, United States
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Philadelphia, Pennsylvania, 19104, United States
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Greenville, South Carolina, 29607, United States
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Memphis, Tennessee, 38120, United States
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Austin, Texas, 78745, United States
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Denton, Texas, 76201, United States
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Plano, Texas, 75075, United States
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Charlottesville, Virginia, 22908, United States
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Fairfax, Virginia, 22031, United States
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Williamsburg, Virginia, 23188, United States
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Tacoma, Washington, 98405, United States
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Morgantown, West Virginia, 26506, United States
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Eau Claire, Wisconsin, 54703, United States
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Gosford, 2250, Australia
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Kogarah, 2217, Australia
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South Brisbane, 4101, Australia
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St Albans, 3021, Australia
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Wollongong, 2500, Australia
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Graz, 8036, Austria
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Linz, 4021, Austria
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Rankweil, 6830, Austria
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Vienna, 1140, Austria
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Vienna, 1210, Austria
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Hasselt, 3500, Belgium
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La Louvière, 7100, Belgium
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Libramont-Chevigny, 6800, Belgium
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Namur, 5000, Belgium
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Sint-Niklaas, 9100, Belgium
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Porto Alegre, 90610-000, Brazil
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Porto Alegre, 91350-200, Brazil
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Salvador, 40170-110, Brazil
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São Paulo, 01246-000, Brazil
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São Paulo, 01327-001, Brazil
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São Paulo, 05652-900, Brazil
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Vancouver, British Columbia, VSZ 4E6, Canada
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Moncton, New Brunswick, E1C 6Z8, Canada
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Halifax, Nova Scotia, B3H 2Y9, Canada
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Brampton, Ontario, L6R 3J7, Canada
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Hamilton, Ontario, L8V 1C3, Canada
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Toronto, Ontario, M5G 1X6, Canada
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Beijing, 100034, China
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Beijing, 100142, China
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Beijing, 101149, China
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Changchun, 130000, China
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Changsha, 410013, China
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Chengdu, 610041, China
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Chengdu, 610072, China
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Chongqing, 400030, China
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Fuzhou, 350011, China
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Guangzhou, 510080, China
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Hangzhou, 310022, China
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Harbin, 150081, China
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Hefei, 230610, China
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Jiamusi, 154007, China
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Jinan, 250117, China
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Nanchang, 330006, China
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Nanjing, 2100008, China
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Shanghai, 200030, China
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Shanghai, 200032, China
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Shanghai, 200433, China
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Shantou, 515041, China
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Shenyang, 110004, China
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Tianjin, 300050, China
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Wuhan, 430030, China
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Wuhan, 430060, China
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Xuzhou, 221009, China
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Zhengzhou, 450008, China
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Zhengzhou, 450052, China
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Boulogne-Billancourt, 92104, France
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Lyon, 69008, France
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Marseille, 13915, France
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Saint-Herblain, 44800, France
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Toulouse, 31400, France
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Bad Saarow, 15526, Germany
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Bielefeld, 33611, Germany
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Bonn, 53127, Germany
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Cologne, 51109, Germany
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Essen, 45147, Germany
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Frankfurt, 60488, Germany
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Freiburg im Breisgau, 79106, Germany
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Gauting, 82131, Germany
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Hamburg, 20251, Germany
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Heidelberg, 69126, Germany
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Krefeld, 47805, Germany
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Minden, 32429, Germany
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Oldenburg, 26121, Germany
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Stuttgart, 70174, Germany
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Troisdorf, 53840, Germany
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Velbert, 42551, Germany
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Budapest, 1083, Hungary
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Budapest, 1121, Hungary
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Budapest, 1145, Hungary
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Debrecen, 4032, Hungary
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Gyöngyös - Mátraháza, 3200, Hungary
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Győr, 9024, Hungary
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Gyula, 5700, Hungary
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Kecskemét, 6000, Hungary
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Szolnok, 5000, Hungary
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Törökbálint, 2045, Hungary
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Bangalore, 560027, India
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Kolkata, 700016, India
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Mumbai, 400012, India
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Nashik, 422011, India
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New Delhi, 11029, India
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Milan, 20141, Italy
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Milan, 20162, Italy
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Monza, 20052, Italy
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Orbassano, 10043, Italy
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Padova, 35128, Italy
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Rozzano, 20089, Italy
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Chūōku, 104-0045, Japan
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Fukuoka, 812-8582, Japan
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Hiroshima, 734-8551, Japan
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Iwakuni-shi, 740-8510, Japan
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Kashiwa, 277-8577, Japan
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Kawasaki-shi, 216-8511, Japan
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Kyoto, 612-8555, Japan
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Matsuyama, 791-0280, Japan
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Nagoya, 464-8681, Japan
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Niigata, 951-8566, Japan
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Osaka, 541-8567, Japan
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Osakasayama-shi, 589-8511, Japan
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Sendai, 981-0914, Japan
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Sunto-gun, 411-8777, Japan
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Yokohama, 241-8515, Japan
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Lodz, 93-338, Poland
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Olsztyn, 10-357, Poland
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Poznan, 60-569, Poland
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Warsaw, 02-781, Poland
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Goyang-si, 10408, South Korea
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Incheon, 21565, South Korea
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Seoul, 03722, South Korea
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Seoul, 06351, South Korea
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Seoul, 5505, South Korea
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Suwon, 16247, South Korea
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A Coruña, 15009, Spain
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Barcelona, 8035, Spain
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L'Hospitalet de Llobregat, 08908, Spain
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Madrid, 28041, Spain
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Málaga, 29010, Spain
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Seville, 41009, Spain
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Zaragoza, 50009, Spain
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Kaohsiung City, 80756, Taiwan
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Taichung, 40705, Taiwan
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Tainan, 73657, Taiwan
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Taipei, 10002, Taiwan
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Taipei, 11217, Taiwan
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Taipei, 11490, Taiwan
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Taoyuan District, 333, Taiwan
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Bangkok, 10210, Thailand
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Bangkok, 10300, Thailand
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Bangkok, 10700, Thailand
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Hat Yai, 90110, Thailand
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Muang, 50200, Thailand
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Ankara, 06530, Turkey (Türkiye)
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Istanbul, 32098, Turkey (Türkiye)
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Huddersfield, HD3 3EA, United Kingdom
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London, SE1 9RT, United Kingdom
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London, SW10 9NH, United Kingdom
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London, SW170QT, United Kingdom
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Maidstone, ME16 9QQ, United Kingdom
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Norwich, NR4 7UY, United Kingdom
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Stoke-on-Trent, ST4 6QG, United Kingdom
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Hanoi, 100000, Vietnam
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Ho Chi Minh City, 700000, Vietnam
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Ho Chi Minh City, 70000, Vietnam
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Vinh, 460000, Vietnam
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
AstraZeneca Clinical Study Information Center
CONTACT
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Masking Details
- TROPION-Lung17 is an open-label study; however, the study will be conducted as 'Sponsor-blind'.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 28, 2025
First Posted
December 18, 2025
Study Start
October 31, 2025
Primary Completion (Estimated)
January 29, 2029
Study Completion (Estimated)
January 29, 2029
Last Updated
April 29, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- AstraZeneca will meet or exceed data availability as per the commitments made to the European Federation of Pharmaceutical Industries and Associations (EFPIA)/Pharmaceutical Research and Manufacturers of America (PhRMA) Data-Sharing Principles. For details of our timelines, please refer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure
- Access Criteria
- When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. A Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca (AZ) group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. "Yes", indicates that AZ are accepting requests for Important Protocol Deviation (IPD), but this does not mean all requests will be approved.