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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.

Phase 3RecruitingAstraZenecaNCT06417814Data as of May 2026

Treatment: Dato-DXd · Osimertinib · Pemetrexed · Carboplatin · CisplatinThis 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).

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Extracted 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

Max 2 prior lines
Min 1 prior line

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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