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 (Jun 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
Treatments studied
Targeted therapy
Chemotherapy
Other
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
Demographics
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 →Frequently asked questions
Is NCT06417814 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior chemotherapy, vascular endothelial growth factor inhibitor, immunotherapy disqualifies patients from enrollment.
Does this trial require EGFR?
Yes, EGFR exon 19 deletion is a required biomarker for enrollment.
Does this trial require EGFR?
Yes, EGFR L858R is a required biomarker for enrollment.
Does this trial require EGFR?
Yes, EGFR G719X is a required biomarker for enrollment.
Is there an age limit?
Yes. Patients must be 130 years or younger.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify