A Study of Ivonescimab in First-Line ES-SCLC
A Phase II Clinical Study of Ivonescimab Combination Therapy as First-Line Treatment for Extensive-Stage Small Cell Lung Cancer (ES-SCLC)
Sponsor: Akeso
No open prediction endpoints
Endpoints are classified and published by ProgramSignal analysts.
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Primary Endpoints (CT.gov)
Objective Response Rate (ORR)
Time frame: Up to approximately 2 years.
Incidence of Adverse Events (AEs)
Time frame: From first dose up to 90 days after last dose.
Secondary Endpoints
Disease Control Rate (DCR)
Duration of Response (DoR)
Time to Response (TTR)
Eligibility Criteria
Inclusion Criteria: * Histologically or cytologically confirmed extensive-stage small cell lung cancer (ES-SCLC). * No prior systemic therapy for ES-SCLC. * At least one measurable lesion as defined by RECIST v1.1. * Age 18 to 75 years. * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. * Adequate organ function. Exclusion Criteria: * Active or untreated central nervous system (CNS) metastases (Treated, stable brain metastases are allowed). * History of severe hypersensitivity to monoclonal antibodies. * Active autoimmune disease requiring systemic treatment within the past 2 years. * Significant cardiovascular disease. * Active hepatitis B or C, or HIV infection. * Interstitial lung disease or non-infectious pneumonitis. * Significant bleeding tendency or risk, including tumor invasion of major blood vessels. * Pregnancy or lactation. * Other active malignancies within 5 years prior to enrollment.
✦ Analyst Commentary
Expert commentary on why this trial matters and what to watch for.
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