drugset / Trial / NCT07234877
Phase II Study of Upfront SRT Plus Ivonescimab/Chemotherapy vs Ivonescimab/Chemotherapy in NSCLC Brain Mets
Phase 2
Not yet recruiting
158 enrolled
European Organisation for Research and Treatment of Cancer - EORTC
Summit Therapeutics · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
This is a randomized, two-arm, comparative Phase II clinical trial designed to evaluate the difference in intracranial progression-free survival (iPFS) between two treatment strategies, assessed locally. Approximately 158 patients will be randomized in a 1:1 ratio. Will be included patients with pathology proven metastatic NSCLC without an actionable genomic alteration for which there is first line targeted treatment available and active asymptomatic brain metastasis (newly diagnosed or progressive). The primary objective is to compare iPFS between the two arms.
Timeline
- Start
- 2026-11
- Primary completion
- 2032-01
- Completion
- 2032-04
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Background | Carboplatin | Small molecule | — | Intravenous |
| Background | Ivonescimab | Monoclonal antibody | 20 mg/kg | Intravenous |
| Background | Paclitaxel | Small molecule | 100 mg/m2 | — |
| Background | Paclitaxel | Small molecule | 175 mg/m2 | Intravenous |
| Background | Paclitaxel | Small molecule | 200 mg/m2 | Intravenous |
| Background | Pemetrexed | Small molecule | 500 mg/m2 | Intravenous |