A Study to Investigate the Efficacy and Safety of Dato-DXd With or Without Osimertinib Compared With Platinum Based Doublet Chemotherapy in Participants With EGFR-Mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer

Recruiting now · Phase 3

Conditions studied: Metastatic Non-small Cell Lung Cancer

In brief

This study will assess the effect of Dato-DXd in combination with osimertinib or Dato-DXd monotherapy versus platinum-based doublet chemotherapy in terms of progression-free survival (PFS).

Key facts

Study ID

NCT06417814

Run by

AstraZeneca

People needed

744

Starts

2024-10-04

Expected to finish

2028-09-27

Last updated by the study team

2026-05-14

Who can join

Age: 18 and older, up to 130. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Histologically or cytologically confirmed non-squamous NSCLC.
• Must have evidence of documented pre-existing EGFRm information (EGFRm known to be associated with (epidermal growth factor receptor [EGFR] tyrosine kinase inhibitor [TKis] sensitivity [Ex19del, L858R, G719X, S768I, or L861Q], either alone or in combination with other EGFR mutations, which may include T790M).
• Documented extra-cranial radiologic progression on prior osimertinib monotherapy (as most recent line of treatment) in the adjuvant, locally advanced, or metastatic setting.
• Less than or equal to (<=2) prior lines of EGFR TKIs (osimertinib is the only permitted prior third generation EGFR TKI).
• At least one lesion, not previously irradiated, that qualifies as a RECIST v1.1 TL at baseline and can be accurately measured at baseline.
• World Health Organization (WHO)/Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
• Adequate bone marrow reserve and organ function within 7 days before randomization.

You may not qualify if…

• Use of chemotherapy, vascular endothelial growth factor inhibitor, immunotherapy or any anti-cancer therapy in the metastatic setting. Platinum-based chemotherapy in non-metastatic setting within 12 months prior to randomization.
• History of another primary malignancy except for malignancy treated with curative intent with no known active disease within 2 years before the first dose of study intervention.
• Any evidence of severe or uncontrolled systemic diseases, including, but not limited to active bleeding diseases, active infection, active ILD/pneumonitis, cardiac disease.
• Has significant third-space fluid retention (example [eg.], ascites or pleural effusion) as judged by the investigator and is not amenable for required repeated drainage.
• History of non-infectious ILD/pneumonitis including radiation pneumonitis that required steroids or drug-induced ILD, has current ILD/pneumonitis, or has suspected ILD/pneumonitis that cannot be ruled out by imaging at screening.
• Has severe pulmonary function compromise resulting from intercurrent pulmonary illnesses.
• Unstable spinal cord compression and/or unstable brain metastases.
• Participants with symptomatic brain metastases (including leptomeningeal involvement).
• Clinically significant corneal disease.
• Uncontrolled infection requiring systemic antibiotics, antivirals, or antifungals, suspected infections or inability to rule out infections. Use of systemic antibiotics within 14 days of randomization.
• Has known human immunodeficiency virus (HIV) infection that is not well controlled.

Where it is running

• Research Site — Pittsburgh, Pennsylvania, United States (enrolling)
• Research Site — Chattanooga, Tennessee, United States (enrolling)
• Research Site — The Bronx, New York, United States (enrolling)
• Research Site — Maumee, Ohio, United States (enrolling)
• Research Site — Fountain Valley, California, United States (enrolling)
• Research Site — Colorado Springs, Colorado, United States (enrolling)
• Research Site — Fort Collins, Colorado, United States (enrolling)
• Research Site — New York, New York, United States (enrolling)
• Research Site — Fayetteville, Arkansas, United States (enrolling)
• Research Site — Jacksonville, Florida, United States (enrolling)
• Research Site — San Diego, California, United States (enrolling)
• Research Site — Chicago, Illinois, United States (enrolling)
• Research Site — Evanston, Illinois, United States (enrolling)
• Research Site — Louisville, Kentucky, United States (enrolling)
• Research Site — Baltimore, Maryland, United States (enrolling)
• Research Site — Bethesda, Maryland, United States (enrolling)
• Research Site — La Jolla, California, United States (enrolling)
• Research Site — Boston, Massachusetts, United States (enrolling)
• Research Site — Detroit, Michigan, United States (enrolling)
• Research Site — Kansas City, Missouri, United States (enrolling)
• Research Site — Omaha, Nebraska, United States (enrolling)
• Research Site — Morristown, New Jersey, United States (enrolling)
• Research Site — Northfield, New Jersey, United States (enrolling)
• Research Site — Athens, Georgia, United States (enrolling)
• Research Site — Nashville, Tennessee, United States (enrolling)

Full record on ClinicalTrials.gov

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