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)

September 2, 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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
400

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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
        • Recruiting
        • Research Site
      • Libramont-Chevigny, Belgium, 6800
        • 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
        • Suspended
        • Research Site
      • Salvador, Brazil, 40170-110
        • Recruiting
        • Research Site
      • São Paulo, Brazil, 01327-001
        • Recruiting
        • Research Site
      • São Paulo, Brazil, 05652-900
        • Suspended
        • Research Site
      • São Paulo, Brazil, 01246-000
        • Suspended
        • 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, 200030
        • Recruiting
        • Research Site
      • Shanghai, China, 200433
        • Recruiting
        • Research Site
      • Shanghai, China, 200032
        • Withdrawn
        • 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
        • Recruiting
        • Research Site
      • Lyon, France, 69008
        • Recruiting
        • Research Site
      • Marseille, France, 13915
        • Recruiting
        • Research Site
      • Saint-Herblain, France, 44800
        • Recruiting
        • Research Site
      • Toulouse, France, 31400
        • Recruiting
        • Research Site
  • Germany
      • Bad Saarow, Germany, 15526
        • Recruiting
        • Research Site
      • Bielefeld, Germany, 33611
        • Recruiting
        • Research Site
      • Bonn, Germany, 53127
        • Recruiting
        • Research Site
      • Cologne, Germany, 51109
        • Recruiting
        • Research Site
      • Essen, Germany, 45147
        • Recruiting
        • Research Site
      • Frankfurt, Germany, 60488
        • Recruiting
        • Research Site
      • Freiburg im Breisgau, Germany, 79106
        • Withdrawn
        • Research Site
      • Gauting, Germany, 82131
        • Recruiting
        • Research Site
      • Hamburg, Germany, 20251
        • Recruiting
        • Research Site
      • Heidelberg, Germany, 69126
        • Recruiting
        • Research Site
      • Krefeld, Germany, 47805
        • Recruiting
        • Research Site
      • Minden, Germany, 32429
        • Recruiting
        • Research Site
      • Oldenburg, Germany, 26121
        • 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
        • Recruiting
        • Research Site
      • Budapest, Hungary, 1121
        • Not yet recruiting
        • Research Site
      • Budapest, Hungary, 1122
        • Not yet recruiting
        • Research Site
      • Debrecen, Hungary, 4032
        • Recruiting
        • Research Site
      • Gyula, Hungary, 5700
        • Not yet recruiting
        • Research Site
      • Gyöngyös - Mátraháza, Hungary, 3200
        • 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
        • Withdrawn
        • 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
        • 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
        • Recruiting
        • Research Site
      • Olsztyn, Poland, 10-357
        • 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
        • Recruiting
        • Research Site
      • Madrid, Spain, 28041
        • 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
        • 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
        • Withdrawn
        • 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
      • Hinsdale, Illinois, United States, 60521
        • Not yet 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
      • Lancaster, Pennsylvania, United States, 17601
        • 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, 700000
        • Recruiting
        • Research Site
      • Ho Chi Minh City, Vietnam, 70 449
        • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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 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.

    • 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 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).

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)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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
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
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).

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.

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.

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

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
AstraZeneca

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 31, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 29, 2029

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 29, 2029

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 28, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 17, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 18, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 4, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 2, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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 IPD, but this does not mean all requests will be shared.

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

No

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.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings