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
18 Years and older, Male and Female
D516KC00001 (primary)
2024-511362-37-00 ( Registry Identifier ) (REGISTR
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.
Eligibility
- 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.
Treatment Sites in Georgia
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