This is an single-arm, multicenter phase II study to evaluate the safety and efficacy of Sacituzumab Tirumotecan (sac-TMT) plus anlotinib in previously treated extensive-stage small cell lung cancer (ES-SCLC). The study is expected to enroll up to 33 eligible patients.
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.
1.History of other primary malignancies within 5 years prior to signing informed consent, except for: radically treated malignancies with no recurrence within 5 years; adequately treated non-melanoma skin cancer, cervical carcinoma in situ, thyroid cancer, or other malignancies considered cured.
2.Prior pathological diagnosis of combined small cell lung cancer (e.g., mixed SCLC and NSCLC), transformed NSCLC (SCLC transformed to NSCLC), or transformed SCLC (NSCLC transformed to SCLC).
3.Prior anti-tumor therapy within specified washout periods before first study dose: chemotherapy, radiotherapy, biologics, endocrine therapy, immunotherapy within 4 weeks; topical anti-tumor agents within 5 half-lives; nitrosoureas or mitomycin C within 6 weeks; oral fluoropyrimidines or small-molecule targeted agents within 5 half-lives; anti-tumor traditional Chinese medicine within 2 weeks.
4.Treatment with any other investigational drug or therapy within 4 weeks prior to first study dose.
Sichuan University
Lead sponsor
Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.
Collaborator
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Collaborator