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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 (Jun 2026). This Phase 3 trial studies multiple treatments including Datopotamab deruxtecan (Dato-DXd) and Docetaxel for non-small cell lung cancer (nsclc).

Phase 3RecruitingAstraZenecaNCT07291037Data as of Jun 2026Location: International · 20 countries

Treatment: Datopotamab deruxtecan (Dato-DXd) · DocetaxelTROPION-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).

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Extracted eligibility criteria

Treatments studied

Targeted therapy

Datopotamab deruxtecan (Dato-DXd)

Chemotherapy

Docetaxel

Cancer type

Non-Small Cell Lung Carcinoma

Biomarker criteria

Required: ALK wild-type

Required: BRAF wild-type

Required: EGFR wild-type

Required: HER2 (ERBB2) wild-type

Required: KRAS wild-type

Required: MET wild-type

Required: NTRK1 wild-type

Required: NTRK2 wild-type

Required: NTRK3 wild-type

Required: RET wild-type

Required: ROS1 wild-type

Required: TACSTD2 positive (normalised membrane ratio (nmr) positive)

Disease stage

Required: Stage IIIB, IIIC, IV

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

Max 2 prior lines
Min 1 prior line

Must have received: platinum-based chemotherapy — advanced or metastatic

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.

Must have received: anti-PD-1 therapy — advanced or metastatic

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.

Must have received: anti-PD-L1 therapy — advanced or metastatic

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.

Lab requirements

Blood counts

adequate bone marrow reserve

Kidney function

Liver function

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 ALK?

Yes, ALK wild-type is a required biomarker for enrollment.

Does this trial require BRAF?

Yes, BRAF wild-type is a required biomarker for enrollment.

Does this trial require EGFR?

Yes, EGFR 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.

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