drugset
drugset / Trial / NCT07715396

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

NCT07715396 ↗

Phase 3 Not yet recruiting 230 enrolled AIO-Studien-gGmbH BeOne Medicines · collab
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2026-10-30
Primary completion
2031-10-30
Completion
2031-10-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Carboplatin Small molecule 5 unknown Intravenous
Subject Carboplatin Small molecule 6 unknown Intravenous
Subject Cisplatin Other / unclassified 75 mg/m2 Intravenous
Subject Paclitaxel Small molecule 100 mg/m2 Intravenous
Subject Paclitaxel Small molecule 175 mg/m2 Intravenous
Subject Paclitaxel Small molecule 200 mg/m2 Intravenous
Comparator Pembrolizumab Monoclonal antibody 200 mg Intravenous
Subject Pemetrexed Small molecule 500 mg/m2 Intravenous
Comparator Tislelizumab Monoclonal antibody 200 mg Intravenous

Indications

non-small cell lung carcinoma