Clinical Trial

Addition of Platinum-based Chemotherapy to Tislelizumab in PD-L1high Metastatic Non-small Cell Lung Cancer With a High Tumor Burden

Study acronym: High Five
Not Yet Recruiting Phase 3
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Summary
AIO-TRK/YMO-0425 (High Five) is a phase III, open-label randomized-controlled, multicenter study to evaluate the progression-free survival by the addition of platinum-based chemotherapy to immunotherapy (IO) compared to IO monotherapy in patients with PD-L1high mNSCLC featuring a high tumor burden.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2026-07-15.
Trial Details
NCT Number NCT07715396
Lead Sponsor AIO-Studien-gGmbH
Collaborators: BeOne Medicines
Conditions Non-small Cell Lung Cancer Metastatic
Enrollment 230 participants
Start Date 2026-10-30
Primary Completion 2031-10-30 (estimated)
Study Completion 2031-10-30 (estimated)
Updated on ClinicalTrials.gov 2026-07-22