NCT07234877

A Randomized Phase II Study Evaluating Upfront SRT to All Brain Metastases Followed by Ivonescimab Plus Chemotherapy Versus Upfront Ivonescimab Plus Chemotherapy in Patients With Asymptomatic Active Brain Metastases From NSCLC

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 158 (estimated)
• Sponsor: European Organisation for Research and Treatment of Cancer - EORTC · Network
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Non Small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	ivonescimab	ivonescimab iv at 20 mg/kg every 3 weeks

Timeline

• Start date: 2026-04-01
• Primary completion: 2031-01-01
• Completion: 2031-10-01
• First posted: 2025-11-19
• Last updated: 2025-11-19