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Phase III Study for TROP2-positive Advanced Lung Cancer

This study is testing a drug called datopotamab deruxtecan (Dato-DXd) against a standard chemotherapy drug, docetaxel, for people with advanced or metastatic non-small cell lung cancer (NSCLC). This is for lung cancer that has already been treated and is TROP2-positive, meaning it has a specific protein on the cancer cells. You might be able to join if you have Stage IIIB, IIIC, or Stage IV non-squamous NSCLC without certain genetic changes (actionable genomic alterations like EGFR, ALK, ROS1). The study aims to see if Dato-DXd can help people live longer without their cancer getting worse (progression-free survival) and if it helps them live longer overall (overall survival). The study is planned to include about 400 participants, but its current status is unclear.

Study design
This is a Phase III, two-arm study where participants are randomly assigned to receive either datopotamab deruxtecan or docetaxel. It is an open-label study, meaning both you and your doctors will know which treatment you are receiving.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The study will follow participants for progression-free survival for approximately 2.5 years and overall survival for approximately 3.5 years.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07291037

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

Recruiting
PHASE3Ages 18+InterventionalTreatment
AstraZeneca
~400 participants
Updated 2026-07-01 on ClinicalTrials.gov
What's tested:Datopotamab deruxtecan (Dato-DXd)Docetaxel

At a glance

Recruiting sites
162 of 205 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Progression-free survival (PFS)
Measured over Approximately 2.5 years
+1 more outcome measured

Conditions

Non-small Cell Lung Cancer (NSCLC)

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Where it's being run

205 sites across 50 states
China28
Germany16
Japan15
Hungary11
Spain7
Taiwan7
United Kingdom7
California6

Who to contact

AstraZeneca Clinical Study Information Center
[email protected]
1-877-240-9479
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Progression-free survival (PFS)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.

  • Overall survival (OS)Approximately 3.5 years

    OS is defined as the time from randomization until the date of death due to any cause.