Phase 3Not yet recruiting
Addition of Platinum-based Chemotherapy to Tislelizumab in PD-L1high Metastatic Non-small Cell Lung Cancer With a High Tumor Burden (High Five)
- Sponsor
- AIO-Studien-gGmbH (Academic or other)
- Enrolment
- 230 planned
- Conditions
- Non-small Cell Lung Cancer Metastatic
- Interventions
- Tislelizumab; Tislelizumab Combined With Chemotherapy; Pembrolizumab
- Ages
- adults, older adults
- Registry
- NCT07715396, CTIS2026-525497-18-00
Full record on ClinicalTrials.gov
From the registry
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.
Primary outcomes
- Progression-free survival
History
Primary completion expected
Expected to start
Last registry update
Registered