OncoMatch/Clinical Trials/NCT07291037
Phase III Study of Datopotamab Deruxtecan Versus Docetaxel in Previously Treated TROP2-positive Advanced or Metastatic Non-squamous NSCLC Without Actionable Genomic Alterations
Is NCT07291037 recruiting? Yes, currently enrolling (Sep 2026). This Phase 3 trial studies multiple treatments including Datopotamab deruxtecan (Dato-DXd) and Docetaxel for non-small cell lung cancer (nsclc).
Treatment: Datopotamab deruxtecan (Dato-DXd) · Docetaxel — 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).
Check if I qualifyExtracted eligibility criteria
Treatments studied
Targeted therapy
Chemotherapy
Cancer type
Non-Small Cell Lung Carcinoma
Biomarker criteria
Required: EGFR wild-type
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)
Required: ALK wild-type
documented negative test results for ... ALK ... genomic alterations
Required: ROS1 wild-type
documented negative test results for ... ROS1 genomic alterations
Required: NTRK1 wild-type
Has no known tumour genomic alterations in NTRK
Required: NTRK2 wild-type
Has no known tumour genomic alterations in NTRK
Required: NTRK3 wild-type
Has no known tumour genomic alterations in NTRK
Required: BRAF wild-type
Has no known tumour genomic alterations in ... BRAF V600
Required: RET wild-type
Has no known tumour genomic alterations in ... RET
Required: MET exon 14 skipping
Has no known tumour genomic alterations in ... MET exon 14 skipping
Required: KRAS wild-type
Has no known tumour genomic alterations in ... KRAS G12C
Required: HER2 (ERBB2) wild-type
Has no known tumour genomic alterations in ... HER2
Required: TACSTD2 expression (positive)
Prospectively assessed TROP2 NMR positive based on results from an appropriately validated investigational TROP2 RxDx device
Disease stage
Required: Stage IIIB, IIIC, IV
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: platinum-based chemotherapy — 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. Documentation of radiographic disease progression while on or after receiving the most recent treatment regimen for advanced or metastatic NSCLC.
Must have received: anti-PD-1 therapy — 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. Documentation of radiographic disease progression while on or after receiving the most recent treatment regimen for advanced or metastatic NSCLC.
Must have received: anti-PD-L1 therapy — 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. Documentation of radiographic disease progression while on or after receiving the most recent treatment regimen for advanced or metastatic NSCLC.
Lab requirements
Blood counts
Adequate bone marrow reserve and organ function within 7 days before randomisation
Kidney function
Adequate bone marrow reserve and organ function within 7 days before randomisation
Liver function
Adequate bone marrow reserve and organ function within 7 days before randomisation
Adequate bone marrow reserve and organ function within 7 days before randomisation
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Research Site · Chandler, Arizona
- Research Site · Gilbert, Arizona
- Research Site · Goodyear, Arizona
- Research Site · Duarte, California
- Research Site · Irvine, California
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT07291037 currently recruiting?
Yes, this trial is currently recruiting patients.
Is prior treatment required for enrollment?
Yes. Patients must have previously received platinum-based chemotherapy and anti-PD-1 therapy.
Does this trial require EGFR?
Yes, EGFR wild-type is a required biomarker for enrollment.
Does this trial require ALK?
Yes, ALK wild-type is a required biomarker for enrollment.
Does this trial require ROS1?
Yes, ROS1 wild-type is a required biomarker for enrollment.
What disease stage is eligible?
Stage IIIB or IIIC or IV is required.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages