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)

May 29, 2026 updated by: AstraZeneca

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).

Study Overview

Status

Recruiting

Conditions

Non-small Cell Lung Cancer (NSCLC)

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

400

Phase

Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: AstraZeneca Clinical Study Information Center
Phone Number: 1-877-240-9479
Email: information.center@astrazeneca.com

Study Locations

Australia
- - Gosford, Australia, 2250
    - Recruiting
    - Research Site
  - Kogarah, Australia, 2217
    - Recruiting
    - Research Site
  - South Brisbane, Australia, 4101
    - Recruiting
    - Research Site
  - St Albans, Australia, 3021
    - Recruiting
    - Research Site
  - Wollongong, Australia, 2500
    - Recruiting
    - Research Site
Austria
- - Graz, Austria, 8036
    - Not yet recruiting
    - Research Site
  - Linz, Austria, 4021
    - Not yet recruiting
    - Research Site
  - Rankweil, Austria, 6830
    - Recruiting
    - Research Site
  - Vienna, Austria, 1210
    - Recruiting
    - Research Site
  - Vienna, Austria, 1140
    - Recruiting
    - Research Site
Belgium
- - Hasselt, Belgium, 3500
    - Recruiting
    - Research Site
  - La Louvière, Belgium, 7100
    - Not yet recruiting
    - Research Site
  - Libramont-Chevigny, Belgium, 6800
    - Not yet recruiting
    - Research Site
  - Sint-Niklaas, Belgium, 9100
    - Recruiting
    - Research Site
  - Yvoir, Belgium, 5530
    - Recruiting
    - Research Site
Brazil
- - Porto Alegre, Brazil, 91350-200
    - Recruiting
    - Research Site
  - Porto Alegre, Brazil, 90610-000
    - Recruiting
    - Research Site
  - Salvador, Brazil, 40170-110
    - Recruiting
    - Research Site
  - São Paulo, Brazil, 01246-000
    - Recruiting
    - Research Site
  - São Paulo, Brazil, 05652-900
    - Recruiting
    - Research Site
  - São Paulo, Brazil, 01327-001
    - Recruiting
    - Research Site
Canada
- British Columbia
  - Vancouver, British Columbia, Canada, VSZ 4E6
    - Recruiting
    - Research Site
- New Brunswick
  - Moncton, New Brunswick, Canada, E1C 6Z8
    - Recruiting
    - Research Site
- Nova Scotia
  - Halifax, Nova Scotia, Canada, B3H 2Y9
    - Recruiting
    - Research Site
- Ontario
  - Brampton, Ontario, Canada, L6R 3J7
    - Recruiting
    - Research Site
  - Hamilton, Ontario, Canada, L8V 1C3
    - Recruiting
    - Research Site
  - Toronto, Ontario, Canada, M5G 1X6
    - Recruiting
    - Research Site
China
- - Beijing, China, 100034
    - Recruiting
    - Research Site
  - Beijing, China, 100142
    - Recruiting
    - Research Site
  - Beijing, China, 101149
    - Recruiting
    - Research Site
  - Changchun, China, 130000
    - Recruiting
    - Research Site
  - Changsha, China, 410013
    - Recruiting
    - Research Site
  - Chengdu, China, 610041
    - Recruiting
    - Research Site
  - Chengdu, China, 610072
    - Recruiting
    - Research Site
  - Chongqing, China, 400030
    - Recruiting
    - Research Site
  - Fuzhou, China, 350011
    - Recruiting
    - Research Site
  - Guangzhou, China, 510080
    - Recruiting
    - Research Site
  - Hangzhou, China, 310022
    - Recruiting
    - Research Site
  - Harbin, China, 150081
    - Recruiting
    - Research Site
  - Hefei, China, 230610
    - Recruiting
    - Research Site
  - Jiamusi, China, 154007
    - Recruiting
    - Research Site
  - Jinan, China, 250117
    - Recruiting
    - Research Site
  - Nanchang, China, 330006
    - Recruiting
    - Research Site
  - Nanjing, China, 2100008
    - Recruiting
    - Research Site
  - Shanghai, China, 200032
    - Not yet recruiting
    - Research Site
  - Shanghai, China, 200030
    - Recruiting
    - Research Site
  - Shanghai, China, 200433
    - Recruiting
    - Research Site
  - Shantou, China, 515041
    - Recruiting
    - Research Site
  - Shenyang, China, 110004
    - Recruiting
    - Research Site
  - Tianjin, China, 300050
    - Recruiting
    - Research Site
  - Wuhan, China, 430060
    - Recruiting
    - Research Site
  - Wuhan, China, 430030
    - Withdrawn
    - Research Site
  - Xuzhou, China, 221009
    - Withdrawn
    - Research Site
  - Zhengzhou, China, 450008
    - Recruiting
    - Research Site
  - Zhengzhou, China, 450052
    - Recruiting
    - Research Site
France
- - Boulogne-Billancourt, France, 92104
    - Not yet recruiting
    - Research Site
  - Lyon, France, 69008
    - Not yet recruiting
    - Research Site
  - Marseille, France, 13915
    - Recruiting
    - Research Site
  - Saint-Herblain, France, 44800
    - Recruiting
    - Research Site
  - Toulouse, France, 31400
    - Not yet recruiting
    - Research Site
Germany
- - Bad Saarow, Germany, 15526
    - Recruiting
    - Research Site
  - Bielefeld, Germany, 33611
    - Recruiting
    - Research Site
  - Bonn, Germany, 53127
    - Not yet recruiting
    - Research Site
  - Cologne, Germany, 51109
    - Recruiting
    - Research Site
  - Essen, Germany, 45147
    - Not yet recruiting
    - Research Site
  - Frankfurt, Germany, 60488
    - Not yet recruiting
    - Research Site
  - Freiburg im Breisgau, Germany, 79106
    - Withdrawn
    - Research Site
  - Gauting, Germany, 82131
    - Not yet recruiting
    - Research Site
  - Hamburg, Germany, 20251
    - Recruiting
    - Research Site
  - Heidelberg, Germany, 69126
    - Not yet recruiting
    - Research Site
  - Krefeld, Germany, 47805
    - Not yet recruiting
    - Research Site
  - Minden, Germany, 32429
    - Recruiting
    - Research Site
  - Oldenburg, Germany, 26121
    - Not yet recruiting
    - Research Site
  - Stuttgart, Germany, 70174
    - Not yet recruiting
    - Research Site
  - Troisdorf, Germany, 53840
    - Recruiting
    - Research Site
  - Velbert, Germany, 42551
    - Recruiting
    - Research Site
Hungary
- - Budapest, Hungary, 1083
    - Not yet recruiting
    - Research Site
  - Budapest, Hungary, 1145
    - Not yet recruiting
    - Research Site
  - Budapest, Hungary, 1121
    - Not yet recruiting
    - Research Site
  - Debrecen, Hungary, 4032
    - Not yet recruiting
    - Research Site
  - Gyula, Hungary, 5700
    - Not yet recruiting
    - Research Site
  - Gyöngyös - Mátraháza, Hungary, 3200
    - Not yet recruiting
    - Research Site
  - Győr, Hungary, 9024
    - Not yet recruiting
    - Research Site
  - Kecskemét, Hungary, 6000
    - Not yet recruiting
    - Research Site
  - Szolnok, Hungary, 5000
    - Not yet recruiting
    - Research Site
  - Törökbálint, Hungary, 2045
    - Recruiting
    - Research Site
India
- - Bangalore, India, 560027
    - Recruiting
    - Research Site
  - Kolkata, India, 700016
    - Recruiting
    - Research Site
  - Mumbai, India, 400012
    - Recruiting
    - Research Site
  - Nashik, India, 422011
    - Recruiting
    - Research Site
  - New Delhi, India, 11029
    - Recruiting
    - Research Site
Italy
- - Milan, Italy, 20141
    - Not yet recruiting
    - Research Site
  - Milan, Italy, 20162
    - Not yet recruiting
    - Research Site
  - Monza, Italy, 20052
    - Not yet recruiting
    - Research Site
  - Orbassano, Italy, 10043
    - Not yet recruiting
    - Research Site
  - Padova, Italy, 35128
    - Not yet recruiting
    - Research Site
  - Rozzano, Italy, 20089
    - Not yet recruiting
    - Research Site
Japan
- - Chūōku, Japan, 104-0045
    - Recruiting
    - Research Site
  - Fukuoka, Japan, 812-8582
    - Recruiting
    - Research Site
  - Hiroshima, Japan, 734-8551
    - Recruiting
    - Research Site
  - Iwakuni-shi, Japan, 740-8510
    - Recruiting
    - Research Site
  - Kashiwa, Japan, 277-8577
    - Not yet recruiting
    - Research Site
  - Kawasaki-shi, Japan, 216-8511
    - Recruiting
    - Research Site
  - Kyoto, Japan, 612-8555
    - Recruiting
    - Research Site
  - Matsuyama, Japan, 791-0280
    - Recruiting
    - Research Site
  - Nagoya, Japan, 464-8681
    - Recruiting
    - Research Site
  - Niigata, Japan, 951-8566
    - Recruiting
    - Research Site
  - Osaka, Japan, 541-8567
    - Recruiting
    - Research Site
  - Osakasayama-shi, Japan, 589-8511
    - Recruiting
    - Research Site
  - Sendai, Japan, 981-0914
    - Recruiting
    - Research Site
  - Sunto-gun, Japan, 411-8777
    - Recruiting
    - Research Site
  - Yokohama, Japan, 241-8515
    - Recruiting
    - Research Site
Poland
- - Lodz, Poland, 93-338
    - Not yet recruiting
    - Research Site
  - Olsztyn, Poland, 10-357
    - Not yet recruiting
    - Research Site
  - Poznan, Poland, 60-569
    - Recruiting
    - Research Site
  - Warsaw, Poland, 02-781
    - Not yet recruiting
    - Research Site
South Korea
- - Goyang-si, South Korea, 10408
    - Recruiting
    - Research Site
  - Incheon, South Korea, 21565
    - Recruiting
    - Research Site
  - Seoul, South Korea, 06351
    - Recruiting
    - Research Site
  - Seoul, South Korea, 5505
    - Recruiting
    - Research Site
  - Seoul, South Korea, 03722
    - Recruiting
    - Research Site
  - Suwon, South Korea, 16247
    - Recruiting
    - Research Site
Spain
- - A Coruña, Spain, 15009
    - Not yet recruiting
    - Research Site
  - Barcelona, Spain, 8035
    - Not yet recruiting
    - Research Site
  - L'Hospitalet de Llobregat, Spain, 08908
    - Not yet recruiting
    - Research Site
  - Madrid, Spain, 28041
    - Not yet recruiting
    - Research Site
  - Málaga, Spain, 29010
    - Not yet recruiting
    - Research Site
  - Seville, Spain, 41009
    - Not yet recruiting
    - Research Site
  - Zaragoza, Spain, 50009
    - Not yet recruiting
    - Research Site
Taiwan
- - Kaohsiung City, Taiwan, 80756
    - Recruiting
    - Research Site
  - Taichung, Taiwan, 40705
    - Recruiting
    - Research Site
  - Tainan, Taiwan, 73657
    - Recruiting
    - Research Site
  - Taipei, Taiwan, 10002
    - Recruiting
    - Research Site
  - Taipei, Taiwan, 11490
    - Recruiting
    - Research Site
  - Taipei, Taiwan, 11217
    - Recruiting
    - Research Site
  - Taoyuan, Taiwan, 333
    - Recruiting
    - Research Site
Thailand
- - Bangkok, Thailand, 10210
    - Recruiting
    - Research Site
  - Bangkok, Thailand, 10300
    - Recruiting
    - Research Site
  - Bangkok, Thailand, 10700
    - Recruiting
    - Research Site
  - Hat Yai, Thailand, 90110
    - Recruiting
    - Research Site
  - Muang, Thailand, 50200
    - Recruiting
    - Research Site
Turkey (Türkiye)
- - Ankara, Turkey (Türkiye), 06530
    - Recruiting
    - Research Site
  - Istanbul, Turkey (Türkiye), 32098
    - Recruiting
    - Research Site
United Kingdom
- - Huddersfield, United Kingdom, HD3 3EA
    - Recruiting
    - Research Site
  - London, United Kingdom, SE1 9RT
    - Not yet recruiting
    - Research Site
  - London, United Kingdom, SW170QT
    - Recruiting
    - Research Site
  - London, United Kingdom, SW10 9NH
    - Not yet recruiting
    - Research Site
  - Maidstone, United Kingdom, ME16 9QQ
    - Withdrawn
    - Research Site
  - Norwich, United Kingdom, NR4 7UY
    - Recruiting
    - Research Site
  - Stoke-on-Trent, United Kingdom, ST4 6QG
    - Not yet recruiting
    - Research Site
United States
- Arizona
  - Chandler, Arizona, United States, 85224
    - Recruiting
    - Research Site
  - Gilbert, Arizona, United States, 85234
    - Recruiting
    - Research Site
  - Goodyear, Arizona, United States, 85338
    - Recruiting
    - Research Site
- California
  - Duarte, California, United States, 91010
    - Recruiting
    - Research Site
  - Irvine, California, United States, 92618
    - Recruiting
    - Research Site
  - La Jolla, California, United States, 92093
    - Recruiting
    - Research Site
  - Loma Linda, California, United States, 92350
    - Recruiting
    - Research Site
  - Los Angeles, California, United States, 90095
    - Not yet recruiting
    - Research Site
  - San Diego, California, United States, 92123
    - Recruiting
    - Research Site
- Colorado
  - Grand Junction, Colorado, United States, 81501
    - Recruiting
    - Research Site
  - Wheat Ridge, Colorado, United States, 80033
    - Recruiting
    - Research Site
- Delaware
  - Newark, Delaware, United States, 19713
    - Recruiting
    - Research Site
- District of Columbia
  - Washington D.C., District of Columbia, United States, 20037
    - Not yet recruiting
    - Research Site
- Florida
  - Fort Myers, Florida, United States, 33901
    - Recruiting
    - Research Site
  - Jacksonville, Florida, United States, 32224
    - Recruiting
    - Research Site
  - St. Petersburg, Florida, United States, 33709
    - Recruiting
    - Research Site
  - Tampa, Florida, United States, 33612
    - Recruiting
    - Research Site
  - West Palm Beach, Florida, United States, 33401
    - Recruiting
    - Research Site
- Georgia
  - Marietta, Georgia, United States, 30060
    - Recruiting
    - Research Site
  - Newnan, Georgia, United States, 30265
    - Recruiting
    - Research Site
- Illinois
  - Chicago, Illinois, United States, 60637
    - Recruiting
    - Research Site
  - Chicago, Illinois, United States, 60612
    - Recruiting
    - Research Site
  - Niles, Illinois, United States, 60714
    - Recruiting
    - Research Site
  - Zion, Illinois, United States, 60099
    - Recruiting
    - Research Site
- Kentucky
  - Louisville, Kentucky, United States, 40207
    - Recruiting
    - Research Site
- Maine
  - South Portland, Maine, United States, 04106
    - Recruiting
    - Research Site
- Maryland
  - Baltimore, Maryland, United States, 21201
    - Recruiting
    - Research Site
  - Brandywine, Maryland, United States, 20613
    - Recruiting
    - Research Site
- Massachusetts
  - Boston, Massachusetts, United States, 02215
    - Recruiting
    - Research Site
- Michigan
  - Detroit, Michigan, United States, 48202
    - Recruiting
    - Research Site
- Minnesota
  - Rochester, Minnesota, United States, 55905
    - Recruiting
    - Research Site
- Missouri
  - Bridgeton, Missouri, United States, 63044
    - Recruiting
    - Research Site
  - Columbia, Missouri, United States, 65212
    - Withdrawn
    - Research Site
- Nebraska
  - Lincoln, Nebraska, United States, 68516
    - Recruiting
    - Research Site
- New Mexico
  - Albuquerque, New Mexico, United States, 87109
    - Recruiting
    - Research Site
- New York
  - East Syracuse, New York, United States, 13057
    - Recruiting
    - Research Site
- Oregon
  - Portland, Oregon, United States, 97239
    - Withdrawn
    - Research Site
- Pennsylvania
  - Hershey, Pennsylvania, United States, 17033
    - Recruiting
    - Research Site
  - Philadelphia, Pennsylvania, United States, 19104
    - Not yet recruiting
    - Research Site
- South Carolina
  - Greenville, South Carolina, United States, 29607
    - Recruiting
    - Research Site
- Tennessee
  - Memphis, Tennessee, United States, 38120
    - Recruiting
    - Research Site
- Texas
  - Austin, Texas, United States, 78745
    - Recruiting
    - Research Site
  - Denton, Texas, United States, 76201
    - Recruiting
    - Research Site
  - Plano, Texas, United States, 75075
    - Recruiting
    - Research Site
- Virginia
  - Charlottesville, Virginia, United States, 22908
    - Recruiting
    - Research Site
  - Fairfax, Virginia, United States, 22031
    - Recruiting
    - Research Site
  - Williamsburg, Virginia, United States, 23188
    - Recruiting
    - Research Site
- Washington
  - Tacoma, Washington, United States, 98405
    - Recruiting
    - Research Site
- West Virginia
  - Morgantown, West Virginia, United States, 26506
    - Recruiting
    - Research Site
- Wisconsin
  - Eau Claire, Wisconsin, United States, 54703
    - Recruiting
    - Research Site
Vietnam
- - Hanoi, Vietnam, 100000
    - Recruiting
    - Research Site
  - Ho Chi Minh City, Vietnam, 70000
    - Recruiting
    - Research Site
  - Ho Chi Minh City, Vietnam, 700000
    - Recruiting
    - Research Site
  - Vinh, Vietnam, 460000
    - Recruiting
    - Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

Adult
Older Adult

Accepts Healthy Volunteers

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: None (Open Label)

Number of Arms

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression-free survival (PFS) Time Frame: Approximately 2.5 years	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) Time Frame: Approximately 3.5 years	OS is defined as the time from randomization until the date of death due to any cause.	Approximately 3.5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Objective response rate (ORR) Time Frame: Approximately 2.5 years	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).	Approximately 2.5 years
Duration of response (DoR) Time Frame: Approximately 2.5 years	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.	Approximately 2.5 years
Time to second progression or death (PFS2) Time Frame: Approximately 2.5 years	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.	Approximately 2.5 years
Exposure-efficacy relationship Time Frame: Approximately 2.5 years	Evaluate the relationship between plasma concentrations of Dato-DXd (µg/mL) and efficacy endpoints (PFS, OS), as evaluated by cox-proportional hazard model.	Approximately 2.5 years
Exposure-safety relationship Time Frame: Approximately 2.5 years	Evaluate the correlation between concentrations of Dato-DXd (µg/mL) and safety endpoints (including Gr3+AE, AESIs), as evaluated by logistic regression	Approximately 2.5 years
Covariates effect on exposure Time Frame: Approximately 2.5 years	Evaluate the relationship between covariates (including but not limited to age, sex, body weight, race) and plasma concentrations of Dato-DXd (µg/mL) and/or DXd (ng/mL), as evaluated by population PK model	Approximately 2.5 years
Immunogenicity of datopotamab deruxtecan (Dato-DXd) Time Frame: Approximately 2.5 years	Presence of antidrug antibodies (ADAs) for Dato-DXd.	Approximately 2.5 years
Participant-reported lung cancer symptoms of non-small cell lung cancer (NSCLC) Time Frame: Approximately 2.5 years	Time to deterioration (TTD) in pulmonary symptoms (dyspnoea, cough, and chest pain) as measured by the Non-Small Cell Lung Cancer Symptom Assessment Questionnaire (NSCLC-SAQ). Scores range from a minimum of 0 to a maximum of 20, with higher scores indicating more symptom burden. 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).	Approximately 2.5 years
Participant-reported physical functioning Time Frame: Approximately 2.5 years	Time to deterioration (TTD) in physical functioning as measured by Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form - Physical Function 8c. 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).	Approximately 2.5 years
Participant-reported global health status (GHS)/quality of life (QoL) Time Frame: Approximately 2.5 years	Time to deterioration (TTD) in GHS/QoL as measured by the European Organization for Research and Treatment of Cancer Item Library 172 (EORTC IL172). Scores range from a minimum of 0 to a maximum of 100, with higher scores indicating a better outcome. 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).	Approximately 2.5 years
Correlation of TROP2 expression at various cut offs with clinical response Time Frame: Approximately 2.5 years	Evaluate the relationship between TROP2 NMR expression and efficacy endpoints.	Approximately 2.5 years
Diagnostic development and biomarker assay concordance analysis Time Frame: Approximately 2.5 years	Evaluate the relationship between TROP2 NMR status at a defined cutoff and efficacy endpoints, as determined by the diagnostic device.	Approximately 2.5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Collaborators

Daiichi Sankyo

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 31, 2025

Primary Completion (Estimated)

January 29, 2029

Study Completion (Estimated)

January 29, 2029

Study Registration Dates

First Submitted

October 28, 2025

First Submitted That Met QC Criteria

December 17, 2025

First Posted (Actual)

December 18, 2025

Study Record Updates

Last Update Posted (Actual)

June 1, 2026

Last Update Submitted That Met QC Criteria

May 29, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

D763QC00001
2024-520101-39-00 (Other Identifier: EU CT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing 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

IPD Sharing 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.

IPD Sharing Supporting Information Type

STUDY_PROTOCOL
SAP
CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Non-small Cell Lung Cancer (NSCLC)

Revolution Medicines, Inc.

Recruiting

Study of Daraxonrasib (RMC-6236) in Patients With RAS Mutated NSCLC (RASolve 301) (RASolve 301)

Non-Small Cell Lung Cancer | NSCLC | NSCLC (Non-small Cell Lung Cancer) | NSCLC (Advanced Non-small Cell Lung Cancer) | NSCLC (Non-small Cell Lung Carcinoma)

Japan, Netherlands, Hong Kong, United States, United Kingdom, Belgium, Australia, Spain, Germany, Switzerland, Italy, Taiwan, France, Singapore, Poland, South Korea, Puerto Rico, Ireland, New Zealand
H. Lee Moffitt Cancer Center and Research Institute
Nestle Health Science

Withdrawn

Immunonutrition to Reduce Toxicities in Non-Small Cell Lung Cancer

NSCLC | Non Small Cell Lung Cancer | Non-small Cell Lung Cancer | NSCLC Stage IIIB | Non-small Cell Lung Cancer Stage IIIB | NSCLC, Stage IIIA | Non-small Cell Lung Cancer Stage ⅢA

United States
Mythic Therapeutics

Terminated

Clinical Study of Antibody-Drug Conjugate MYTX-011 in Subjects With Non-Small Cell Lung Cancer

Non-Small Cell Lung Cancer | NSCLC | Advanced Non-Small Cell Lung Cancer | NSCLC Stage IV | NSCLC Stage IIIB | Advanced Non-Small Cell Squamous Lung Cancer | Advanced Non-Small Cell Non-Squamous Lung Cancer

United States, Spain, Taiwan, Australia, United Kingdom, France, South Korea
Massachusetts General Hospital
Summit Therapeutics

Not yet recruiting

Ivonescimab Alone And With Carboplatin/Pemetrexed For NSCLC

Lung Cancer Non Small Cell | Genomic Alterations | Lung Cancer (Non-Small Cell) | Lung Cancer (NSCLC) | Lung Cancer Non-Small Cell Cancer (NSCLC) | Lung Cancer - Non Small Cell

United States
Guangzhou University of Traditional Chinese Medicine
Guang'anmen Hospital of China Academy of Chinese Medical Sciences; Beijing... and other collaborators

Not yet recruiting

A Prospective Multicenter Study of the Association Between TCM Syndromes and EGFR-TKI Efficacy in Lung Cancer Patients

Non Small Cell Lung Cancer NSCLC

China
IRCCS Azienda Ospedaliero-Universitaria di Bologna

Recruiting

The Role of DNA and RNA in NGS Analyses for Advaced Stage NSCLC Patients

Non Small Cell Lung Cancer NSCLC

Italy
Ono Pharmaceutical Co., Ltd.
Bristol-Myers Squibb

Recruiting

A Retrospective Observational Study of Nivolumab in Combination With Chemotherapy as Neoadjuvant Therapy for Resectable NSCLC Patients: Real-World Experience in Taiwan (NEOREAL)

Non Small Cell Lung Cancer NSCLC

Taiwan
Multitude Therapeutics Inc.

Not yet recruiting

AMT-116 in Combination With Ivosidan in Patients With Lung Cancer

Advanced Non-small Cell Lung Cancer (NSCLC)

China
Pfizer

Not yet recruiting

Symbiotic-Lung-10: A Study to Learn About PF-08634404 Alone or in Combination in Early-stage or Locally Advanced NSCLC

Carcinoma | Lung Neoplasms | Non-Small Cell Lung Cancer | Lung Disease | Non-Small-Cell Lung | Carcinoma, Non-Small-Cell Lung (NSCLC) | Non-small Cell Lung Cancer, Squamous | Non-small Cell Lung Cancer, Non-squamous | Lung Cancer (NSCLC)
Technische Universität Dresden
Deutsche Krebshilfe e.V., Bonn (Germany); Universitätsklinikum Köln

Not yet recruiting

Immune-Marker Platform for Patients With Advanced Lung Cancer (IMPALUX)

NSCLC Stage IIIB~IV | NSCLC (Advanced Non-small Cell Lung Cancer) | NSCLC Non-small Cell Lung Cancer

Germany

Clinical Trials on Datopotamab deruxtecan (Dato-DXd)

AstraZeneca

Recruiting

A Study of AZD3470, a PRMT5 Inhibitor, Given as Monotherapy and in Combination in Patients With MTAP Deficient Advanced/Metastatic Solid Tumors (PRIMROSE)

Advanced Solid Tumors That Are MTAP Deficient

United States, China, Spain, Australia, Japan, Netherlands, France, South Korea
Daiichi Sankyo
AstraZeneca

Approved for marketing

Medical Access Program for Datopotamab Deruxtecan in EGFRm NSCLC Patients

EGFRm Advanced Non-Small Cell Lung Cancer | EGFRm Metastatic Non-Small Cell Lung Cancer

United States
AstraZeneca
Daiichi Sankyo

Not yet recruiting

An Open-label, Single-arm Study of Prophylaxis for Datopotamab Deruxtecan (Dato-DXd) -Related Stomatitis in Eligible Patients With Metastatic or Inoperable Locally Recurrent Breast Cancer or Locally Advanced or Metastatic Epidermal Growth Factor Receptor-Mutated Non-small Cell Lung Cancer. (TROPION-SWISH)

Stomatitis

United States
AstraZeneca
Daiichi Sankyo

Active, not recruiting

A Study of Dato-DXd in Chinese Patients With Advanced Non-Small Cell Lung Cancer, Triple-negative Breast Cancer and Other Solid Tumors (TROPION-PanTumor02)

Carcinoma, Non-Small-Cell Lung | Triple Negative Breast Cancer

China
UNC Lineberger Comprehensive Cancer Center
AstraZeneca; Translational Breast Cancer Research Consortium

Recruiting

PREDICT-RD: ctDNA Surveillance in TNBC With Residual Disease (PREDICT-RD)

Breast Cancer | Residual Disease | Triple Negative Breast Cancer (TNBC) | Stage II/III

United States
Sarah Sammons, MD
Daiichi Sankyo

Recruiting

DATO-BASE: DATOpotamab-deruxtecan for Breast Cancer Brain metAstaSEs

Breast Cancer | Breast Cancer Female | Metastatic Triple-Negative Breast Carcinoma | HER2-negative Breast Cancer | HER2 Negative Breast Carcinoma | ER-negative Breast Cancer | ER Positive Breast Cancer

United States
Queen Mary University of London
AstraZeneca

Recruiting

Investigating Datopotamab Deruxtecan Plus Durvalumab Versus Datopotamab Deruxtecan in Patients With PDL1-negative Metastatic Triple-negative Breast Cancer (DIAMOND)

Triple Negative Breast Cancer

United Kingdom
Daiichi Sankyo Co., Ltd.
AstraZeneca; Daiichi Sankyo

Active, not recruiting

First-in-human Study of DS-1062a for Advanced Solid Tumors (TROPION-PanTumor01)

Triple Negative Breast Cancer | Non-small Cell Lung Cancer | Hormone Receptor Positive Breast Cancer

United States, Japan
Ana C Garrido-Castro, MD
AstraZeneca; Translational Breast Cancer Research Consortium

Recruiting

TReatment of ADC-Refractory Breast CancEr With Dato-DXd or T-DXd: TRADE DXd (TRADE DXd)

Breast Cancer | Metastatic Breast Cancer | HER2-negative Breast Cancer | HER2-low Breast Cancer

United States
AstraZeneca

Recruiting

Study of AZD9574 as Monotherapy and in Combination With Anti-cancer Agents in Participants With Advanced Solid Malignancies (CERTIS1)

Advanced Solid Malignancies

United States, Spain, Australia, Sweden, United Kingdom, Germany, South Korea

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)

Study Overview

Status

Conditions

Intervention / Treatment

Detailed Description

Study Type

Enrollment (Estimated)

Phase

Contacts and Locations

Study Contact

Study Locations

Participation Criteria

Eligibility Criteria

Ages Eligible for Study

Accepts Healthy Volunteers

Description

Study Plan

How is the study designed?

Design Details

Number of Arms

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Secondary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Collaborators and Investigators

Sponsor

Collaborators

Study record dates

Study Major Dates

Study Start (Actual)

Primary Completion (Estimated)

Study Completion (Estimated)

Study Registration Dates

First Submitted

First Submitted That Met QC Criteria

First Posted (Actual)

Study Record Updates

Last Update Posted (Actual)

Last Update Submitted That Met QC Criteria

Last Verified

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

IPD Plan Description

IPD Sharing Time Frame

IPD Sharing Access Criteria

IPD Sharing Supporting Information Type

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Studies a U.S. FDA-regulated device product

Clinical Trials on Non-small Cell Lung Cancer (NSCLC)

Clinical Trials on Datopotamab deruxtecan (Dato-DXd)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Norway

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations