Phase II Study of Platinum/Etoposide Plus Ivonescimab for Extensive-Stage Small Cell Lung Cancer
Phase II Dose Optimization Study of Platinum/Etoposide Plus Ivonescimab (CEI) as First-Line Treatment of Extensive-Stage Small Cell Lung Cancer
Sponsor: PrECOG, LLC. + Summit Therapeutics
No open prediction endpoints
Endpoints are classified and published by ProgramSignal analysts.
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Primary Endpoints (CT.gov)
Optimal Dose of Ivonescimab in Combination with Carboplatin and Etoposide - Overall Response Rate (ORR)
Time frame: 18 months
Optimal Dose of Ivonescimab in Combination with Carboplatin and Etoposide - Grade 3-5 Treatment-Related Toxicity Rate
Time frame: 18 months
Secondary Endpoints
Progression-Free Survival (PFS) of Ivonescimab in Combination with Carboplatin and Etoposide
Overall Survival (OS) of of Ivonescimab in Combination with Carboplatin and Etoposide
Disease Control Rate (DCR) of Ivonescimab in Combination with Carboplatin and Etoposide
Eligibility Criteria
Selection Criteria: * Patients must have pathologically confirmed Extensive Stage Small Cell Lung Cancer (ES-SCLC). * No prior systemic therapy for the disease under study (ES-SCLC). * Patients must have measurable disease according to Response Evaluation Criteria for Solid Tumors (RECIST) v1.1. * Patient must be ≥ 18 years of age. * Patient must have an ECOG performance status of 0-1. * Patient must have the ability to understand and willingness to sign a written informed consent document. * Willing to provide archived tumor tissue (if sufficient tumor tissue available) and blood samples for research. * Patient must have adequate organ function and marrow function as defined below, obtained ≤ 14 days prior to registration/randomization. No blood transfusions or growth factor therapy allowed within 7 days of screening labs. * Absolute Neutrophil Count (ANC) ≥ 1500/microliter (mcL) * Platelets ˃100,000/mcL * Hemoglobin \>9.0 gram/deciliter (g/dL) * Prothrombin time (PT) or int…
Read full criteria on CT.gov →✦ Analyst Commentary
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