Safety and Efficacy of Ivonescimab and Chemotherapy Plus Stereotactic Radiosurgery (SRS) in the Treatment of Non-Small Cell Lung Cancer Brain Metastases
Memorial Sloan Kettering Cancer Center
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.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Histologically or cytologically confirmed non-small cell lung cancer, including squamous and non-squamous histologies. 2. At least one brain metastasis measuring ≥ 1.0 cm and ≤ 3.5 cm in diameter, deemed safe for treatment with SRS by an attending radiation oncologist 3. PD-L1 tumor proportion score available 4. ECOG performance status 0-1 (See Appendix II for performance status criteria) 5. Age ≥ 18 years 6. Expected life expectancy greater than 3 months 7. Participant or Legally Authorized Representative (LAR) able to provide written informed consent 8. Participant wi…
Interventions
- DrugIvonescimab
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.
- RadiationStereotactic Radiosurgery
(9Gy x 3 fractions) starting on Days 7-10.
Locations (7)
- Memorial Sloan Kettering Basking Ridge (All Protocol Activities)Basking Ridge, New Jersey
- Memorial Sloan Kettering Monmouth (All Protocol Activities)Middletown, New Jersey
- Memorial Sloan Kettering Bergen (All Protocol Activities)Montvale, New Jersey
- Memorial Sloan Kettering Suffolk - Commack (All Protocol Activities)Commack, New York
- Memorial Sloan Kettering Westchester (All Protocol Activities)Harrison, New York
- Memorial Sloan Kettering Cancer Center (All Protocol Activities)New York, New York