NCT07535437

A Study of Ivonescimab in Combination With Dato-DXd or Osimertinib in People With Non-Small Cell Lung Cancer

A Phase 1/2 Trial of Ivonescimab With Dato-DXd or Osimertinib in Patients With Metastatic EGFR-mutant Non-small Cell Lung Cancer That Progressed on EGFR TKI Therapy

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 66 (estimated)
• Sponsor: Memorial Sloan Kettering Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Type	Name	Description
DRUG	Ivonescimab	20 mg/kg
DRUG	Dato-DXd	dose escalation 4 mg/kg 6 mg/kg
DRUG	Osimertinib	dose escalation 40mg 80 mg

Timeline

• Start date: 2026-04-09
• Primary completion: 2028-04-01
• Completion: 2028-04-01
• First posted: 2026-04-17
• Last updated: 2026-04-17

Locations

7 sites across 1 country: United States

Regulatory

• FDA-regulated drug study