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Looking for participantsPhase3

Phase III Study of Datopotamab Deruxtecan Versus Docetaxel in Previously Treated TROP2-positive Advanced or Metastatic Non-squamous NSCLC Without Actionable Genomic Alterations

Sponsor: AstraZeneca

NCT ID: NCT07291037

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
Datopotamab deruxtecan (Dato-DXd) (drug), Docetaxel (drug)
How long the study runs
Study runs about 39 months (dates as stated)
About the drug or intervention
Datopotamab deruxtecan (Dato-DXd) — drug: Dato-DXd administered intravenously (IV) · Docetaxel — drug: Docetaxel administered intravenously (IV)
Patient visit burden
Not specified by the sponsor

In plain English

This is a phase 3 study for people with a type of lung cancer called non-small cell lung cancer (NSCLC) that has spread or cannot be treated with surgery, and has not responded to earlier treatment. It tests a drug called datopotamab deruxtecan against an existing drug called docetaxel. The study is paid for by AstraZeneca.

Who can take part

  • Have stage IIIB, IIIC or stage IV non-squamous non-small cell lung cancer that has grown or spread despite the most recent treatment
  • Tested negative for certain gene changes (such as EGFR, ALK and ROS1) that have approved targeted treatments available
  • Have a tumour that tests positive for a protein called TROP2
  • Have already had platinum chemotherapy and immunotherapy (anti-PD-1 or anti-PD-L1 treatment), either together or one after the other
  • Can provide a stored tumour sample for TROP2 testing
  • Have at least one tumour that can be measured on a scan
  • Are well enough day-to-day (performance status 0 or 1)
  • Have healthy enough bone marrow and organs, checked by blood tests within 7 days of joining

Who may not be able to

  • Have squamous or mixed non-small cell lung cancer, or small cell lung cancer
  • Have cancer that could be treated with local treatment alone, such as radiotherapy or surgery
  • Have had another cancer in the last 3 years, unless it was treated with the aim of cure and is not active
  • Have spinal cord compression or cancer spread to the brain, unless it causes no symptoms, is stable and has not needed steroid or anti-seizure medicines for at least 7 days
  • Have a significant eye problem affecting the cornea
  • Have active or uncontrolled hepatitis B or C, or HIV that is not well controlled
  • Have an infection needing medicines through a drip
  • Have or may have a type of lung inflammation (interstitial lung disease or pneumonitis), including past radiation pneumonitis treated with steroids
  • Have severely reduced lung function, in the doctor's judgement

What taking part involves

  • • Being given either the study drug datopotamab deruxtecan or the comparison drug docetaxel
  • • Scans to measure the tumour before and during the study
  • • Providing a tumour sample for testing
  • • Blood tests to check bone marrow and organ function

Time commitment: Not stated — ask the trial team

Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.

Type of study
Testing a treatment
Ages
18 Years and over
Who
All
Number of participants
400
Started
2025-10-31
Last checked
2026-08

Plain English Summary

What is this study?

  • • Testing a new treatment for non-small cell lung cancer (nsclc)
  • • Phase3 - 400 participants
  • • 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)

Who can take part?

  • • Ages 18 Years and over
  • • Diagnosed with non-small cell lung cancer (nsclc)

Where?

  • • Huddersfield - Research Site
  • • London - Research Site
  • • London - Research Site
  • • London - Research Site
  • • +3 more UK sites

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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).

More detail

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.

Non-small Cell Lung Cancer (NSCLC)

How this trial compares with your answers

Answer 2 more questions to improve match

What we know so far

Condition· Matched your search
Age· Tell us your age for better matching
Gender· Tell us your sex for better matching

Still need:

  • • Tell us your age for better matching
  • • Tell us your sex for better matching

Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 18 Years and over
  • Who can join: All genders

Biomarkers mentioned

EGFRALKROS1documented negativeNTRKBRAFRETMET

Treatment history

Treatments you must have had:

  • ✓ of therapy

What the study is looking for

  • ✓Participants must have documented negative test results for EGFR (eg, exon 19 deletion or exon 21 L858R, exon 21...
  • ✓Note: Participants whose tumours harbour BRAF (exception V600) or KRAS (exception G12C) mutations are eligible for...
  • ✓Prospectively assessed TROP2 NMR positive based on results from an appropriately validated investigational TROP2...
  • ✓Documentation of radiographic disease progression while on or after receiving the most recent treatment regimen for...
  • ✓Provision of acceptable formalin fixed and paraffin embedded (FFPE) tumour sample for assessment of TROP2.

Who cannot take part

  • ✗Squamous, mixed NSCLC, or small cell lung cancer (SCLC) histology.
  • ✗NSCLC disease that is eligible for definitive local therapy alone.
  • ✗Spinal cord compression or brain metastases, unless not causing symptoms, stable, and not requiring treatment with...
  • ✗Clinically significant corneal disease.
  • ✗Has active or uncontrolled hepatitis B or C virus infection.
See the full criteria
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).

Where Is This Study? (7 UK sites)

Research Site

Huddersfield HD3 3EA, United Kingdom

Recruiting

Research Site

London SE1 9RT, United Kingdom

NOT_YET_RECRUITING

Research Site

London SW10 9NH, United Kingdom

NOT_YET_RECRUITING

Research Site

London SW170QT, United Kingdom

Recruiting

Research Site

Maidstone ME16 9QQ, United Kingdom

WITHDRAWN

Research Site

Norwich NR4 7UY, United Kingdom

Recruiting

Research Site

Stoke-on-Trent ST4 6QG, United Kingdom

NOT_YET_RECRUITING

How to Get in Touch

AstraZeneca Clinical Study Information Center

Sponsor contact

CONTACT

1-877-240-9479 information.center@astrazeneca.com
Data sourced from ClinicalTrials.gov · Last verified: 2026-08