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OncoMatch/Clinical Trials/NCT06357533

Phase III, Open-label, Study of First-line Dato-DXd in Combination With Rilvegostomig for Advanced Non-squamous NSCLC With High PD-L1 Expression (TC ≥ 50%) and Without Actionable Genomic Alterations

Is NCT06357533 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies multiple treatments including Datopotamab Deruxtecan and Rilvegostomig for non-small cell lung cancer.

Phase 3RecruitingAstraZenecaNCT06357533Data as of May 2026

Treatment: Datopotamab Deruxtecan · Rilvegostomig · Pembrolizumab — The purpose of this study is to evaluate efficacy and safety of Dato-DXd in combination with rilvegostomig or rilvegostomig monotherapy compared with pembrolizumab monotherapy as a first line therapy in participants with locally advanced or metastatic non-squamous NSCLC with high PD-L1 expression (TC ≥ 50%) and without actionable genomic alterations.

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Extracted eligibility criteria

Cancer type

Non-Small Cell Lung Carcinoma

Biomarker criteria

Required: EGFR sensitizing mutation (absence)

Absence of sensitising EGFR mutations

Required: ALK rearrangement (absence)

Absence of ... ALK ... rearrangements

Required: ROS1 rearrangement (absence)

Absence of ... ROS1 rearrangements

Required: PD-L1 (CD274) overexpression (TC ≥ 50%)

Known tumour PD-L1 expression status defined as TC ≥ 50%

Disease stage

Required: Stage IIIB, IIIC, IV

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

No prior treatment (treatment-naive required)
Max 0 prior lines

Cannot have received: systemic therapy

Lab requirements

Blood counts

adequate bone marrow reserve

Kidney function

Liver function

Adequate bone marrow reserve and organ function

Structured fields extracted by AI. May contain errors — verify against the official protocol.

US trial sites

  • Research Site · Anchorage, Alaska
  • Research Site · Tucson, Arizona
  • Research Site · Little Rock, Arkansas
  • Research Site · Springdale, Arkansas
  • Research Site · Anaheim, California

Showing up to 5 US sites. See all sites on ClinicalTrials.gov →

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