A Phase III, Open-label, Sponsor-blind, Randomized Study of Dato-DXd With or Without Osimertinib Versus Platinum-based Doublet Chemotherapy for Participants With EGFR-mutated Locally Advanced or Metastatic Non-small Cell Lung Cancer Whose Disease Has Progressed on Prior Osimertinib Treatment (TROPION-Lung15)
AstraZeneca
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).
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 participants with epidermal growth factor receptor gene mutation (EGFRm) locally advanced or metastatic non-small cell lung cancer (NSCLC) whose disease has progressed on prior osimertinib treatment. Participants will be randomized in a 1:1:1 ratio to one of the following intervention groups: 1. Dato-DXd + osimertinib combination therapy 2. Dato-DXd monotherapy 3. Platinum-based doublet chemotherapy…
Eligibility
- Age range
- 18–130 years
- Sex
- All
- Healthy volunteers
- No
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…
Interventions
- DrugDato-DXd
Dato-DXd will be administered as IV infusion.
- DrugOsimertinib
Osimertinib will be administered orally.
- DrugPemetrexed
Pemetrexed will be administered as IV infusion.
- DrugCarboplatin
Carboplatin will be administered as IV infusion.
- DrugCisplatin
Cisplatin will be administered as IV infusion.
Locations (302)
- Research SiteFayetteville, Arkansas
- Research SiteDuarte, California
- Research SiteFountain Valley, California
- Research SiteLa Jolla, California
- Research SiteLos Angeles, California
- Research SiteSan Diego, California