OncoMatch/Clinical Trials/NCT06417814
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
Is NCT06417814 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies multiple treatments for metastatic non-small cell lung cancer.
Treatment: Dato-DXd · Osimertinib · Pemetrexed · Carboplatin · Cisplatin — 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).
Check if I qualifyExtracted eligibility criteria
Cancer type
Non-Small Cell Lung Carcinoma
Biomarker criteria
Required: EGFR exon 19 deletion
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)
Required: EGFR L858R
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)
Required: EGFR G719X
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)
Required: EGFR S768I
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)
Required: EGFR L861Q
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)
Disease stage
Metastatic disease required
At least one lesion, not previously irradiated, that qualifies as a RECIST v1.1 TL at baseline and can be accurately measured at baseline.
Performance status
WHO/ECOG 0–1
Prior therapy
Must have received: EGFR tyrosine kinase inhibitor (osimertinib) — adjuvant, locally advanced, or metastatic
Documented extra-cranial radiologic progression on prior osimertinib monotherapy (as most recent line of treatment) in the adjuvant, locally advanced, or metastatic setting.
Cannot have received: chemotherapy
Exception: Platinum-based chemotherapy in non-metastatic setting within 12 months prior to randomization
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.
Cannot have received: vascular endothelial growth factor inhibitor
Use of chemotherapy, vascular endothelial growth factor inhibitor, immunotherapy or any anti-cancer therapy in the metastatic setting.
Cannot have received: immunotherapy
Use of chemotherapy, vascular endothelial growth factor inhibitor, immunotherapy or any anti-cancer therapy in the metastatic setting.
Cannot have received: anti-cancer therapy
Use of chemotherapy, vascular endothelial growth factor inhibitor, immunotherapy or any anti-cancer therapy in the metastatic setting.
Lab requirements
Blood counts
Adequate bone marrow reserve and organ function within 7 days before randomization.
Kidney function
Adequate bone marrow reserve and organ function within 7 days before randomization.
Liver function
Adequate bone marrow reserve and organ function within 7 days before randomization.
Adequate bone marrow reserve and organ function within 7 days before randomization.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Research Site · Fayetteville, Arkansas
- Research Site · Duarte, California
- Research Site · Fountain Valley, California
- Research Site · La Jolla, California
- Research Site · Los Angeles, California
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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