A Phase 3 interventional study of Datopotamab deruxtecan (Dato-DXd) and Docetaxel in Non-small Cell Lung Cancer (NSCLC), sponsored by AstraZeneca. Recruiting at 206 sites in 21 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-04.
Sponsored by AstraZeneca · Phase 3, Interventional, and Treatment
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).
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.
6,485 studies on the registry are indexed under Carcinoma, Non-Small-Cell Lung; 1,630 are open to participants now.
This study's planned enrollment of 400 is above the median of 62 across 5,211 interventional studies indexed under Carcinoma, Non-Small-Cell Lung.
Browse Carcinoma, Non-Small-Cell Lung studies →AstraZeneca is the lead sponsor of 3,429 studies on the registry; 270 are open to participants now.
Of its 357 completed or terminated interventional studies of FDA-regulated products, 173 (48%) have results posted.
Counted across the registry records on this site, refreshed daily.
- 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:
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.
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.
Exclusion Criteria:
Participants in the Dato-DXd monotherapy group will receive Dato-DXd as intravenous (IV) infusion every 3 weeks (Q3W) on Day 1 of each 21-day cycle.
Drug: Datopotamab deruxtecan (Dato-DXd)
Participants in the docetaxel monotherapy group will receive docetaxel as intravenous (IV) infusion every 3 weeks (Q3W) on Day 1 of each 21-day cycle.
Drug: Docetaxel
Dato-DXd administered intravenously (IV)
Also known as: DS-1062a
Docetaxel administered intravenously (IV)
Progression-free survival (PFS)
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.
Time frame: Approximately 2.5 years
Overall survival (OS)
OS is defined as the time from randomization until the date of death due to any cause.
Time frame: Approximately 3.5 years
Objective response rate (ORR)
ORR is defined as the proportion of participants who have a confirmed complete response (CR) or confirmed partial response (PR), as determined by Blinded Independent Central Review (BICR) per Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST 1.1).
Time frame: Approximately 2.5 years
Duration of response (DoR)
DoR is defined as the time from the date of first documented response until the date of documented 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.
Time frame: Approximately 2.5 years
Time to second progression or death (PFS2)
PFS2 is defined as the time from randomization until the earliest of the progression event (following the initial progression event), after first subsequent therapy, or death. The date of the second progression will be recorded by the Investigator in the electronic Case Report Form (eCRF) and defined according to local standard clinical practice based on radiological or clinical progression.
Time frame: Approximately 2.5 years
Participant-reported lung cancer symptoms of non-small cell lung cancer (NSCLC)
Time to deterioration (TTD) in pulmonary symptoms (dyspnoea, cough, and chest pain). TTD is defined as time from randomization to the date of first deterioration. Deterioration is defined as change from baseline that reaches an meaningful change threshold (MCT).
Time frame: Approximately 2.5 years
Participant-reported physical functioning
Time to deterioration (TTD) in physical functioning. TTD is defined as time from randomization to the date of first deterioration. Deterioration is defined as change from baseline that reaches a meaningful change threshold (MCT).
Time frame: Approximately 2.5 years
Participant-reported global health status (GHS)/quality of life (QoL)
Time to deterioration (TTD) in GHS/QoL. TTD is defined as time from the date of randomisation to the date of first deterioration. Deterioration is defined as change from baseline that reaches a meaningful change threshold (MCT)
Time frame: Approximately 2.5 years
Diagnostic development and biomarker assay concordance analysis
Evaluate the relationship between TROP2 NMR status at a defined cutoff and efficacy endpoints, as determined by the diagnostic device.
Time frame: Approximately 2.5 years
Showing the first 100 of 206 sites across 21 countries.
Plan to share: Yes — Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca (AZ) group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. "Yes", indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
Supporting information: Study protocol, Sap, Csr
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