Ivonescimab With Dato-DXd or Osimertinib Phase 1
Summary
NIH ClinicalTrials.gov registered Phase 1 trial NCT07535437 evaluating ivonescimab in combination with Dato-DXd or osimertinib for treatment of EGFR-mutated non-small cell lung cancer. The dose-escalation study will assess safety and tolerability to determine optimal dosing. Participants with NSCLC harboring EGFR mutations will receive fixed-dose ivonescimab with escalating doses of either Dato-DXd or osimertinib.
What changed
NIH ClinicalTrials.gov registered a new Phase 1 clinical trial NCT07535437 for ivonescimab combined with Dato-DXd or osimertinib in EGFR-mutated non-small cell lung cancer. The trial uses a dose-escalation design with fixed-dose ivonescimab to identify optimal dosing combinations. Study interventions include ivonescimab, datopotamab deruxtecan (Dato-DXd), and osimertinib.
Pharmaceutical companies and clinical research organizations conducting oncology trials should note this registration for competitive intelligence and potential trial matching for eligible patients. This is a routine clinical trial registration with no immediate compliance obligations for external parties.
Archived snapshot
Apr 18, 2026GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.
A Study of Ivonescimab in Combination With Dato-DXd or Osimertinib in People With Non-Small Cell Lung Cancer
Phase 1 NCT07535437 Kind: PHASE1 Apr 17, 2026
Abstract
The researchers are doing this study to find out whether ivonescimab in combination with datopotamab deruxtecan- (Dato-DXd) or osimertinib are safe and effective treatments in people with non-small cell lung cancer (NSCLC) that has an EGFR mutation. We will test different doses of the Dato-DXd or osimertinib with an unchanging (fixed) dose of ivonescimab to find the best dose that causes few or mild side effects in participants. Once the dose is found the researchers will test ivonescimab with Dato-DXd or osimertinib in a new group of participants to see if it is effective in treating their NSCLC with an EGFR mutation.
Conditions: Non-Small Cell Lung Cancer
Interventions: Ivonescimab, Dato-DXd, Osimertinib
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