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

Active:	Yes
Cancer Type:	Lung Cancer	NCT ID:	NCT06417814
Trial Phases:	Phase III	Protocol IDs:	D516KC00001 (primary) 2024-511362-37-00 ( Registry Identifier ) (REGISTR
Eligibility:	18 Years and older, Male and Female	Study Type:	Treatment
Study Sponsor:	AstraZeneca Pharmaceuticals LP
NCI Full Details:	http://clinicaltrials.gov/show/NCT06417814

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).

Objectives

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

Participants will receive study intervention until Response Evaluation Criteria in Solid
Tumors, Version 1.1 (RECIST v1.1) -defined radiological progression by the investigator,
unacceptable toxicity, or other discontinuation criterion is met.

After study intervention discontinuation, all participants will undergo an end of
treatment (EoT) visit within 35 days of discontinuation and will be followed up for
safety assessments 28 (+ 7) days after their last dose of study intervention.

Treatment Sites in Georgia

University Cancer and Blood Center, LLC - Athens Medical Oncology
3320 Old Jefferson Road
Building 800
Athens, GA 30607
www.universitycancer.com

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