🇮🇪Ireland
16°C Partly Cloudy · Dublin
Live Updates
--:--:-- IST
Writer Login
Latest
Clinical Trials in the UK / NCT07291037
Recruiting Phase 3

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

NCT07291037 · tracked via the Priya Life Science UK tracker
Sponsor
AstraZeneca
Phase
Phase 3
Started
2025-10-31
Last updated
2026-09-04

Condition(s) studied

Non-small Cell Lung Cancer (NSCLC)

Investigational drug(s) / intervention(s)

Datopotamab deruxtecan (Dato-DXd)Docetaxel

Datopotamab deruxtecan (Dato-DXd): Dato-DXd administered intravenously (IV)

Docetaxel: Docetaxel administered intravenously (IV)

Study summary

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).

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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).

Primary outcome measure(s)

Trial sites (206)

FacilityCityRegionStatus
Research Site Chandler Arizona Recruiting
Research Site Gilbert Arizona Recruiting
Research Site Goodyear Arizona Recruiting
Research Site Duarte California Recruiting
Research Site Irvine California Recruiting
Research Site La Jolla California Recruiting
Research Site Loma Linda California Recruiting
Research Site Los Angeles California Recruiting
Research Site San Diego California Recruiting
Research Site Grand Junction Colorado Recruiting
Research Site Wheat Ridge Colorado Recruiting
Research Site Newark Delaware Recruiting
Research Site Washington D.C. District of Columbia Withdrawn
Research Site Fort Myers Florida Recruiting
Research Site Jacksonville Florida Recruiting
Research Site St. Petersburg Florida Recruiting
Research Site Tampa Florida Recruiting
Research Site West Palm Beach Florida Recruiting
Research Site Marietta Georgia Recruiting
Research Site Newnan Georgia Recruiting
Research Site Chicago Illinois Recruiting
Research Site Chicago Illinois Recruiting
Research Site Hinsdale Illinois Not Yet Recruiting
Research Site Niles Illinois Recruiting
Research Site Zion Illinois Recruiting
Research Site Louisville Kentucky Recruiting
Research Site South Portland Maine Recruiting
Research Site Baltimore Maryland Recruiting
Research Site Brandywine Maryland Recruiting
Research Site Boston Massachusetts Recruiting
Research Site Detroit Michigan Recruiting
Research Site Rochester Minnesota Recruiting
Research Site Bridgeton Missouri Recruiting
Research Site Columbia Missouri Withdrawn
Research Site Lincoln Nebraska Recruiting
Research Site Albuquerque New Mexico Recruiting
Research Site East Syracuse New York Recruiting
Research Site Portland Oregon Withdrawn
Research Site Hershey Pennsylvania Recruiting
Research Site Lancaster Pennsylvania Recruiting

+ 166 more sites — see the full list on the official registry below.

More AstraZeneca trials in the UK

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07291037 on ClinicalTrials.gov ↗ ← All trials in the UK