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Phase II Study of Upfront SRT Plus Ivonescimab/Chemotherapy vs Ivonescimab/Chemotherapy in NSCLC Brain Mets

StatusNot Yet Recruiting
PhasePhase 2
Started
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Record History

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  1. Notable Primary completion date: Jan 2031 to Jan 2032v2 Show 6 more changesShow less
    • Start date: Apr 2026 to Nov 2026
    • Study sites: 0 to 26
    • Study completion date: Oct 2031 to Apr 2032
    • Interventions: ivonescimab (Drug) to Carboplatin (Drug), Ivonescimab (Drug), Paclitaxel (Drug), Paclitaxel-albumin (Drug), Pemetrexed (Drug), Stereotactic Radiosurgery (SRS) or…
    • Study description expanded, about 794 words
    • Study title shortened, about 17 words
  2. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07234877
Lead Sponsor European Organisation for Research and Treatment of Cancer - EORTC
Collaborators: Summit Therapeutics
Conditions
(from sponsor)
Non Small Cell Lung Cancer
Related terms Carcinoma, Non-Small-Cell Lung
Enrollment 158 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov