Study on Ivonescimab, Chemotherapy, and Stereotactic Radiosurgery for People with Non-Small Cell Lung Cancer

Inclusion Criteria

• Diagnosed with non-small cell lung cancer, including squamous and non-squamous types.
• Have at least one brain tumor between 1.0 cm and 3.5 cm in size, suitable for targeted radiation treatment.
• Have a PD-L1 tumor proportion score available.
• Be in good overall health with an ECOG performance status of 0 or 1.
• Be 18 years or older.
• Have a life expectancy of more than 3 months.
• Be able to provide written informed consent.
• Willing to follow all study requirements.
• Have adequate organ function, including:
  • Blood counts within specified limits without recent transfusions or growth factor therapy.
  • Kidney function within specified limits.
  • Liver function within specified limits.
  • Blood clotting times within specified limits unless on stable anticoagulation therapy.
• Any side effects from previous treatments must be resolved to baseline or mild levels.
• If on steroids, must be on a stable low dose for at least one week before joining the study.
• Women of childbearing potential must use effective contraception during the study and for 90 days after the last dose of ivonescimab.
• Men must use barrier contraception during the study and for 90 days after the last dose of ivonescimab, and ensure their female partners use effective contraception.

Exclusion Criteria

• Have small cell lung cancer.
• Have had previous brain radiation, except for specific conditions.
• Unable to have a contrast-enhanced brain MRI.
• Have a brain tumor in the brainstem that is 1.0 cm or larger.
• Have leptomeningeal disease (cancer spread to the membranes around the brain and spinal cord).
• Have had previous immunotherapy, unless specific conditions are met.
• Have had other cancers within the last 3 years, except for certain non-threatening types.
• Have had major surgery or serious injury within 4 weeks before joining the study.
• Have a history of bleeding disorders or significant bleeding within 4 weeks before joining the study.
• Have uncontrolled high blood pressure.
• Have active autoimmune or lung disease requiring systemic treatment within the last 2 years, with some exceptions.
• Have a history of major heart or vascular diseases within the last 12 months.
• Have had severe lung disease or gastrointestinal issues within the last 6 months.
• Have imaging showing major blood vessel invasion or risk of bleeding.
• Have had a previous brain bleed.
• Have received a live vaccine within 4 weeks before joining the study.
• Have a severe infection within 4 weeks before joining the study.
• Have significant nerve damage.
• Have uncontrolled fluid buildup around the lungs, heart, or abdomen.
• Have a history of non-infectious pneumonia requiring high-dose steroids.
• Have inflammatory bowel disease.
• Have uncontrolled HIV, hepatitis B, or hepatitis C infections.
• Have had an organ or stem cell transplant.
• Have allergies to study drugs or similar medications.
• Have any condition that could interfere with the study or increase medical risk.
• Are breastfeeding or plan to breastfeed during the study.