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.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
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
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
Where Is This Study? (7 UK sites)
Research Site
Huddersfield HD3 3EA, United Kingdom
Research Site
London SE1 9RT, United Kingdom
Research Site
London SW10 9NH, United Kingdom
Research Site
London SW170QT, United Kingdom
Research Site
Maidstone ME16 9QQ, United Kingdom
Research Site
Norwich NR4 7UY, United Kingdom
Research Site
Stoke-on-Trent ST4 6QG, United Kingdom
How to Get in Touch
AstraZeneca Clinical Study Information Center
Sponsor contactCONTACT
