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 (Jun 2026). This Phase 3 trial studies multiple treatments including Datopotamab Deruxtecan and Rilvegostomig for non-small cell lung cancer.
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.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Immunotherapy
Targeted therapy
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
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 →Frequently asked questions
Is NCT06357533 currently recruiting?
Yes, this trial is currently recruiting patients.
Can patients have received prior systemic therapy?
No. This trial requires treatment-naive patients — prior systemic therapy is an exclusion criterion.
Does this trial require EGFR?
Yes, EGFR sensitizing mutation is a required biomarker for enrollment.
Does this trial require ALK?
Yes, ALK rearrangement is a required biomarker for enrollment.
Does this trial require ROS1?
Yes, ROS1 rearrangement is a required biomarker for enrollment.
What disease stage is eligible?
Stage IIIB or IIIC or IV is required.
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