Sacituzumab Tirumotecan in Combination With Anlotinib in Previously Treated Patients With Extensive-Stage Small Cell Lung Cancer (ES-SCLC)
Sacituzumab Tirumotecan in Combination With Anlotinib in Previously Treated Patients With Extensive-Stage Small Cell Lung Cancer (ES-SCLC): A Prospective, Single-Arm, Phase II Study (STAR-01)
Sponsor: Sichuan University + Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd., Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
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: 24 months
Secondary Endpoints
Progression Free Survival (PFS)
Overall Survival (OS)
Disease control response (DCR)
Eligibility Criteria
Inclusion Criteria: * 1.Voluntary participation with written informed consent obtained prior to any study-specific procedures. * 2.Age ≥ 18 years and ≤ 75 years, regardless of sex. * 3.Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. * 4.Life expectancy of at least 3 months. * 5.Histologically or cytologically confirmed small cell lung cancer (SCLC) based on pathology and immunohistochemistry/immunophenotyping results; disease staged as extensive-stage SCLC (ES-SCLC) according to the Veterans Administration Lung Study Group (VALG) staging system. * 6.Disease progression (at the time of enrollment) after at least two cycles of platinum-based systemic therapy with or without PD-1/L1 inhibitors; no more than two prior lines of therapy. Note: Adjuvant therapy is considered one prior line if disease progression occurs during treatment or within 6 months of the last adjuvant dose. * 7.At least one measurable lesion as defined by RECIST version 1.1. Lesions previousl…
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