Non-small Cell Lung Cancer (NSCLC)Phase 3TROPION-Lung17NCT07291037
Phase III Study of Datopotamab Deruxtecan Versus Docetaxel in Previously Treated TROP2-positive Advanced or Metastatic Non-squamous NSCLC Without Actionable Genomic Alterations
A Phase 3 study testing Datopotamab deruxtecan (Dato-DXd) and Docetaxel in people with Non-small Cell Lung Cancer (NSCLC), run by AstraZeneca at 206 sites in 21 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-small Cell Lung Cancer (NSCLC)
- What is being tested?
- Datopotamab deruxtecan (Dato-DXd) and Docetaxel
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 206 sitesin 21 countries
- Study dates
- 31 Oct 2025to 29 Jan 2029
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 EGFR (eg, exon 19 deletion or exon 21 L858R, exon 21 L861Q, exon 18 G719X, or exon 20 S768I mutation), ALK, and ROS1 genomic alterations.
- Note: If test results for EGFR, ALK, and ROS1 are not available, participants are required to undergo prospective testing performed centrally for these genomic alterations in a Sponsor-designated central laboratory.
- Has no known tumour genomic alterations in NTRK, BRAF V600, RET, MET exon 14 skipping, KRAS G12C, or HER2. Additionally, participants must not have known tumour genomic alteration of any other actionable driver oncogenes for which there are locally approved targeted first-line therapies.
- Note: Participants whose tumours harbour BRAF (exception V600) or KRAS (exception G12C) mutations are eligible for the study.
- Prospectively assessed TROP2 NMR positive based on results from an appropriately validated investigational TROP2 RxDx device in a Sponsor- designated, regulatory compliant central laboratory.
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- 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.
Who cannot join
- 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.
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- Known human immunodeficiency virus (HIV) infection that is not well controlled.
- Uncontrolled infection requiring intravenous (IV) antibiotics, antivirals, or antifungals.
- History of ILD/pneumonitis, including radiation pneumonitis (apart from radiation pneumonitis that did not require steroids), or drug-induced ILD/pneumonitis, or has suspected ILD/pneumonitis that cannot be ruled out by imaging at screening. Examples of suspected ILD/pneumonitis by imaging include the presence of lung parenchymal fibrosis, such as combined pulmonary fibrosis and emphysema (CPFE), and any radiographic features consistent with interstitial lung abnormalities, including but not limited to, extensive ground glass opacities, reticular opacities, traction bronchiectasis, and honeycombing.
- Has severe pulmonary function compromise resulting from intercurrent pulmonary illnesses including, but not limited to, any underlying pulmonary disorder (eg, pulmonary emboli within 3 months of the study enrolment, severe asthma, severe COPD, restrictive lung disease, symptomatic pleural effusion, etc).
Trial locations and contacts
206 sites in 21 countries. Contact the study team or a site near you to ask about taking part.
AstraZeneca Clinical Study Information Center contact
206 sites in 21 countries
United States51 sites, 48 recruiting
- Recruiting
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Albuquerque, New Mexico, 87109
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Austin, Texas, 78745
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Baltimore, Maryland, 21201
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Boston, Massachusetts, 02215
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Brandywine, Maryland, 20613
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Bridgeton, Missouri, 63044
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Chandler, Arizona, 85224
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Charlottesville, Virginia, 22908
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Chicago, Illinois, 60612
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Chicago, Illinois, 60637
- Withdrawn
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Columbia, Missouri, 65212
- Recruiting
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Denton, Texas, 76201
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Detroit, Michigan, 48202
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Duarte, California, 91010
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East Syracuse, New York, 13057
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Eau Claire, Wisconsin, 54703
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Fairfax, Virginia, 22031
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Fort Myers, Florida, 33901
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Gilbert, Arizona, 85234
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Goodyear, Arizona, 85338
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Grand Junction, Colorado, 81501
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Greenville, South Carolina, 29607
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Hershey, Pennsylvania, 17033
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Hinsdale, Illinois, 60521
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Irvine, California, 92618
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Jacksonville, Florida, 32224
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La Jolla, California, 92093
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Lancaster, Pennsylvania, 17601
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Lincoln, Nebraska, 68516
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Loma Linda, California, 92350
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Los Angeles, California, 90095
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Louisville, Kentucky, 40207
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Marietta, Georgia, 30060
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Memphis, Tennessee, 38120
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Morgantown, West Virginia, 26506
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Newark, Delaware, 19713
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Newnan, Georgia, 30265
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Niles, Illinois, 60714
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Plano, Texas, 75075
- Withdrawn
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Portland, Oregon, 97239
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Rochester, Minnesota, 55905
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San Diego, California, 92123
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South Portland, Maine, 04106
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St. Petersburg, Florida, 33709
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Tacoma, Washington, 98405
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Tampa, Florida, 33612
- Withdrawn
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Washington D.C., District of Columbia, 20037
- Recruiting
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West Palm Beach, Florida, 33401
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Wheat Ridge, Colorado, 80033
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Williamsburg, Virginia, 23188
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Zion, Illinois, 60099
China28 sites, 25 recruiting
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Beijing, 100034
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Beijing, 100142
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Beijing, 101149
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Changchun, 130000
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Changsha, 410013
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Chengdu, 610041
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Chengdu, 610072
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Chongqing, 400030
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Fuzhou, 350011
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Guangzhou, 510080
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Hangzhou, 310022
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Harbin, 150081
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Hefei, 230610
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Jiamusi, 154007
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Jinan, 250117
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Nanchang, 330006
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Nanjing, 2100008
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Shanghai, 200030
- Withdrawn
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Shanghai, 200032
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Shanghai, 200433
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Shantou, 515041
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Shenyang, 110004
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Tianjin, 300050
- Withdrawn
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Wuhan, 430030
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Wuhan, 430060
- Withdrawn
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Xuzhou, 221009
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Zhengzhou, 450008
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Zhengzhou, 450052
Germany16 sites, 15 recruiting
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Bad Saarow, 15526
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Bielefeld, 33611
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Bonn, 53127
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Cologne, 51109
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Essen, 45147
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Frankfurt, 60488
- Withdrawn
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Freiburg im Breisgau, 79106
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Gauting, 82131
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Hamburg, 20251
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Heidelberg, 69126
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Krefeld, 47805
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Minden, 32429
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Oldenburg, 26121
- Not yet recruiting
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Stuttgart, 70174
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Troisdorf, 53840
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Velbert, 42551
Japan15 sites, 15 recruiting
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Chūōku, 104-0045
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Fukuoka, 812-8582
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Hiroshima, 734-8551
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Iwakuni-shi, 740-8510
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Kashiwa, 277-8577
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Kawasaki-shi, 216-8511
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Kyoto, 612-8555
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Matsuyama, 791-0280
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Nagoya, 464-8681
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Niigata, 951-8566
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Osaka, 541-8567
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Osakasayama-shi, 589-8511
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Sendai, 981-0914
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Sunto-gun, 411-8777
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Yokohama, 241-8515
Hungary11 sites, 9 recruiting
- Not yet recruiting
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Budapest, 1083
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Budapest, 1121
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Budapest, 1122
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Budapest, 1145
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Debrecen, 4032
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Gyöngyös - Mátraháza, 3200
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Győr, 9024
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Gyula, 5700
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Kecskemét, 6000
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Szolnok, 5000
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Törökbálint, 2045
Spain7 sites, 7 recruiting
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A Coruña, 15009
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Barcelona, 8035
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L'Hospitalet de Llobregat, 08908
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Madrid, 28041
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Málaga, 29010
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Seville, 41009
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Zaragoza, 50009
Taiwan7 sites, 7 recruiting
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Kaohsiung City, 80756
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Taichung, 40705
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Tainan, 73657
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Taipei, 10002
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Taipei, 11217
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Taipei, 11490
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Taoyuan, 333
United Kingdom7 sites, 6 recruiting
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Huddersfield, HD3 3EA
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London, SE1 9RT
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London, SW10 9NH
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London, SW170QT
- Withdrawn
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Maidstone, ME16 9QQ
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Norwich, NR4 7UY
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Stoke-on-Trent, ST4 6QG
Brazil6 sites, 5 recruiting
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Porto Alegre, 90610-000
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Porto Alegre, 91350-200
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Salvador, 40170-110
- Suspended
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São Paulo, 01246-000
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São Paulo, 01327-001
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São Paulo, 05652-900
Canada6 sites, 6 recruiting
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Brampton, Ontario, L6R 3J7
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Halifax, Nova Scotia, B3H 2Y9
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Hamilton, Ontario, L8V 1C3
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Moncton, New Brunswick, E1C 6Z8
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Toronto, Ontario, M5G 1X6
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Vancouver, British Columbia, VSZ 4E6
Italy6 sites, 6 recruiting
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Milan, 20141
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Milan, 20162
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Monza, 20052
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Orbassano, 10043
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Padova, 35128
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Rozzano, 20089
South Korea6 sites, 6 recruiting
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Goyang-si, 10408
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Incheon, 21565
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Seoul, 03722
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Seoul, 06351
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Seoul, 5505
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Suwon, 16247
Australia5 sites, 4 recruiting
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Gosford, 2250
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Kogarah, 2217
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South Brisbane, 4101
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St Albans, 3021
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Wollongong, 2500
Austria5 sites, 4 recruiting
- Withdrawn
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Graz, 8036
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Linz, 4021
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Rankweil, 6830
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Vienna, 1140
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Vienna, 1210
Belgium5 sites, 5 recruiting
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Hasselt, 3500
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La Louvière, 7100
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Libramont-Chevigny, 6800
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Sint-Niklaas, 9100
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Yvoir, 5530
France5 sites, 5 recruiting
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Boulogne-Billancourt, 92104
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Lyon, 69008
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Marseille, 13915
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Saint-Herblain, 44800
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Toulouse, 31400
India5 sites, 4 recruiting
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Bangalore, 560027
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Kolkata, 700016
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Mumbai, 400012
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Nashik, 422011
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New Delhi, 11029
Thailand5 sites, 5 recruiting
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Bangkok, 10210
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Bangkok, 10300
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Bangkok, 10700
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Hat Yai, 90110
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Muang, 50200
Poland4 sites, 4 recruiting
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Lodz, 93-338
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Olsztyn, 10-357
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Poznan, 60-569
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Warsaw, 02-781
Vietnam4 sites, 4 recruiting
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Hanoi, 100000
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Ho Chi Minh City, 70 449
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Ho Chi Minh City, 700000
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Vinh, 460000
Turkey (Türkiye)2 sites, 2 recruiting
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Ankara, 06530
- Recruiting
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Istanbul, 32098
About this study
Official title: 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)
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).
Read the 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.
- Conditions
- Non-small Cell Lung Cancer (NSCLC)
- Being tested
- Datopotamab deruxtecan (Dato-DXd), Docetaxel
- Keywords
- TROPION-Lung17, Non-small cell lung cancer (NSCLC), Advanced non-squamous NSCLC, Metastatic non-squamous NSCLC, Datopotamab deruxtecan (Dato-DXd; DS-1062a), Docetaxel, Trophoblast cell surface protein 2 (TROP2), Normalised membrane ratio (NMR)
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Datopotamab deruxtecan (Dato-DXd)Drug
Also called DS-1062a
Dato-DXd administered intravenously (IV)
DocetaxelDrug
Docetaxel administered intravenously (IV)
| Study group | Role | What they receive |
|---|---|---|
| Arm A: Datopotamab deruxtecan (Dato-DXd) monotherapy | Experimental | 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. Receives: Drug: Datopotamab deruxtecan (Dato-DXd) |
| Arm B: Docetaxel monotherapy | Active comparator | 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. Receives: Drug: Docetaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Approximately 2.5 years
Overall survival (OS)
OS is defined as the time from randomization until the date of death due to any cause.
Measured: Approximately 3.5 years
Secondary outcomes (7)
Objective response rate (ORR)
ORR is defined as the proportion of participants who have a confirmed complete response (CR) or confirmed partial response (PR), as determined by Blinded Independent Central Review (BICR) per Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST 1.1).
Measured: Approximately 2.5 years
Duration of response (DoR)
DoR is defined as the time from the date of first documented response until the date of documented 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.
Measured: Approximately 2.5 years
Time to second progression or death (PFS2)
PFS2 is defined as the time from randomization until the earliest of the progression event (following the initial progression event), after first subsequent therapy, or death. The date of the second progression will be recorded by the Investigator in the electronic Case Report Form (eCRF) and defined according to local standard clinical practice based on radiological or clinical progression.
Measured: Approximately 2.5 years
Participant-reported lung cancer symptoms of non-small cell lung cancer (NSCLC)
Time to deterioration (TTD) in pulmonary symptoms (dyspnoea, cough, and chest pain).
TTD is defined as time from randomization to the date of first deterioration.
Deterioration is defined as change from baseline that reaches an meaningful change threshold (MCT).
Measured: Approximately 2.5 years
Participant-reported physical functioning
Time to deterioration (TTD) in physical functioning.
TTD is defined as time from randomization to the date of first deterioration.
Deterioration is defined as change from baseline that reaches a meaningful change threshold (MCT).
Measured: Approximately 2.5 years
Participant-reported global health status (GHS)/quality of life (QoL)
Time to deterioration (TTD) in GHS/QoL.
TTD is defined as time from the date of randomisation to the date of first deterioration.
Deterioration is defined as change from baseline that reaches a meaningful change threshold (MCT)
Measured: Approximately 2.5 years
Diagnostic development and biomarker assay concordance analysis
Evaluate the relationship between TROP2 NMR status at a defined cutoff and efficacy endpoints, as determined by the diagnostic device.
Measured: Approximately 2.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2025
- Study start31 Oct 2025
- Primary completion29 Jan 2029 (estimated)
- Study completion29 Jan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-small Cell Lung Cancer (NSCLC)Studies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Arm A: Datopotamab deruxtecan monotherapy Arm B: Docetaxel monotherapy
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Daiichi Sankyo
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07291037
- Sponsor's protocol ID
- D763QC00001
- Other IDs
- 2024-520101-39-00
- Acronym
- TROPION-Lung17
- Status last verified
- Oct 2026
- First submitted
- 28 Oct 2025
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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 IPD, but this does not mean all requests will be shared.