Status:

RECRUITING

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

Lead Sponsor:

AstraZeneca

Collaborating Sponsors:

Daiichi Sankyo

Conditions:

Metastatic Non-small Cell Lung Cancer

Eligibility:

All Genders

18-130 years

Phase:

PHASE3

Brief Summary

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).

Detailed Description

This is a Phase III, open-label, 3-arm, multicenter study assessing the effects of Dato-DXd in combination with osimertinib or Dato-DXd monotherapy versus platinum-based doublet chemotherapy in partic...

Eligibility Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Key Trial Info

Start Date :

October 4 2024

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

September 27 2028

Estimated Enrollment :

744 Patients enrolled

Trial Details

Trial ID

NCT06417814

Start Date

October 4 2024

End Date

September 27 2028

Last Update

March 2 2026

Active Locations (302)

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Page 1 of 76 (302 locations)

1

Research Site

Fayetteville, Arkansas, United States, 72703

2

Research Site

Duarte, California, United States, 91010

3

Research Site

Fountain Valley, California, United States, 92708

4

Research Site

La Jolla, California, United States, 92093