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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)

Status
Not yet recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-520101-39-00
Enrollment
13
Registered
2026-02-26
Start date
Unknown
Completion date
Unknown
Last updated
2026-02-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

TROP2 NMR-positive advanced or metastatic non-squamous non-small cell lung cancer without actionable genomic alterations.

Brief summary

To assess the superiority of Dato-DXd vs docetaxel by assessment of PFS by BICR according to RECIST v1.1 in participants with TROP2 QCS-NMR positive non-squamous NSCLC without AGA., To assess the superiority of Dato-DXd vs docetaxel by assessment of OS in participants with TROP2 QCS-NMR positive non-squamous NSCLC without AGA.

Detailed description

Objective response rate (ORR), Duration of response (DoR), Time to second progression or death (PFS2), Characterise population PK and its relationship with efficacy and safety endpoints, and evaluate the effects of covariates on PK, efficacy, and safety, Presence of antidrug antibody (ADAs) for Dato-DXd, Time to deterioration (TTD) in pulmonary symptoms, physical functioning, and in GHS/QoL, To assess TROP2 diagnostic test performance and relationship with other tumour-derived biomarkers or diagnostics tests, and support test development, To assess the safety and tolerability of Dato-DXd vs docetaxel in participants with TROP2 QCS-NMR positive non-squamous NSCLC without AGA

Interventions

DRUGDatopotamab deruxtecan
DRUGDOCETAXEL

Sponsors

AstraZeneca AB
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
To assess the superiority of Dato-DXd vs docetaxel by assessment of PFS by BICR according to RECIST v1.1 in participants with TROP2 QCS-NMR positive non-squamous NSCLC without AGA., To assess the superiority of Dato-DXd vs docetaxel by assessment of OS in participants with TROP2 QCS-NMR positive non-squamous NSCLC without AGA.

Secondary

MeasureTime frame
Objective response rate (ORR), Duration of response (DoR), Time to second progression or death (PFS2), Characterise population PK and its relationship with efficacy and safety endpoints, and evaluate the effects of covariates on PK, efficacy, and safety, Presence of antidrug antibody (ADAs) for Dato-DXd, Time to deterioration (TTD) in pulmonary symptoms, physical functioning, and in GHS/QoL, To assess TROP2 diagnostic test performance and relationship with other tumour-derived biomarkers or diagnostics tests, and support test development, To assess the safety and tolerability of Dato-DXd vs docetaxel in participants with TROP2 QCS-NMR positive non-squamous NSCLC without AGA

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 27, 2026