NCT07535463

A Study of Ivonescimab, Chemotherapy, and Stereotactic Radiosurgery for People With Non-Small Cell Lung Cancer

Safety and Efficacy of Ivonescimab and Chemotherapy Plus Stereotactic Radiosurgery (SRS) in the Treatment of Non-Small Cell Lung Cancer Brain Metastases

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 53 (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 test the safety of ivonescimab given in combination with standard chemotherapy and stereotactic radiosurgery (SRS) in people with non-small cell lung cancer (NSCLC) that has spread to the brain (brain metastases). The researchers will test different doses of the study drug to find the best dose that causes few or mild side effects in participants. Once the dose is found, the researchers will test it in a new group of participants to see if it is effective in treating their NSCLC brain metastases.

Conditions

• Non-Small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	Ivonescimab	Ivonescimab will be administered IV on Day 1 of the first cycle starting at 10 mg/kg with chemotherapy. Dose escalation will proceed to 15 mg/kg and 20 mg/kg as tolerated.
RADIATION	Stereotactic Radiosurgery	(9Gy x 3 fractions) starting on Days 7-10.

Timeline

• Start date: 2026-04-10
• 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