ClinicaliQ Trial Snapshot
- 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 — Recruiting • Phase III • Oncology • NCT06357533.
- Treatment being tested: Dato-DXd (a HER2-directed antibody-drug conjugate) combined with rilvegostomig (an immunostimulatory agent), versus rilvegostomig alone or pembrolizumab monotherapy, as first-line therapy for advanced non-squamous NSCLC.
- Patient eligibility overview: Adults with locally advanced or metastatic non-squamous NSCLC expressing high PD-L1 (TC ≥50%), without actionable genomic alterations (EGFR, ALK, ROS1 mutations/translocations), treatment-Phase IIIïve for advanced disease.
Use This Page For
- Quick orientation before opening the registry record.
- Checking recruitment status, phase and sponsor at a glance.
- Connecting this trial to nearby guidelines, Drug Science and education.
What This Trial Is Studying
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.
Eligibility Snapshot
- : * Histologically or cytologically documented non-squamous NSCLC. * Stage IIIB or IIIC or Stage IV metastatic NSCLC (according to Edition 8 of the AJCC staging manual) not amenable to curative surgery or definitive chemoradiation. * Absence of sensitising EGFR mutations, and ALK and ROS1 rearrangements, and absence of documented local test result for any other known genomic alteration for which there are locally approved and available targeted first-line therapies. * Must provide tumor sample to determine PD-L1 status, TROP2 status and other biomarkers. * Known tumour PD-L1 expression status defined as TC ≥ 50% * At least one lesion, not previously irradiated that qualifies as a RECIST 1.1 target lesion at baseline * ECOG performance status of 0 or 1 * Adequate bone marrow reserve and organ function
Use the source registry for the full inclusion and exclusion criteria before discussing referral or enrolment.