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
Sponsor: Memorial Sloan Kettering Cancer Center + Summit Therapeutics
No open prediction endpoints
Endpoints are classified and published by ProgramSignal analysts.
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Primary Endpoints (CT.gov)
identify the Recommended Phase 2 Dose (RPD2)
Time frame: 21 days
intracranial progression-free survival (iPFS),
Time frame: 3 months
Eligibility Criteria
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 willing to comply with all requirements of study participation 9. Adequate Organ Function: a. Hematology (no blood transfusions or growth factor therapy used within 7 days of the screening CBC): i. Absolute neutrophil count (ANC) ≥ 1.5 × 10\^9/L ii. Platelet count ≥ 100 × 10\^9/L iii. Hemoglobin ≥ 9.0 g/dL b. Kidneys: i. Creatinine clearance (CrCl) ≥ 50 mL/min using the Cockcroft-Gault formula o…
Read full criteria on CT.gov →✦ Analyst Commentary
Expert commentary on why this trial matters and what to watch for.
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