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.
Single group
Sacituzumab Tirumotecan and Anlotinib
DrugTreatment with Sacituzumab Tirumotecan (4mg/kg IV d1 Q2W) and Anlotinib (8mg po d1-14 Q3W) until confirmed by the investigator as imaging disease progression, intolerable toxicity, subject's request to terminate treatment, or other treatment termination criteria specified in the protocol (based on the first patient). Drug reduction or dose regulation will be implemented according to the research plan.
Objective Response Rate (ORR)
ORR is defined as the proportion of participants who achieve a complete response (CR) or partial response (PR) that is confirmed at least 4 weeks after initial documentation of response.
Progression Free Survival (PFS)
PFS is defined as time from date of randomization until the date of first objective progressive disease (PD) by investigator assessment according to RECIST v1.1 or death from any cause, whichever comes first.
Overall Survival (OS)
OS is defined as the time from randomization until the date of death from any cause.
Disease control response (DCR)
DCR is defined as the proportion of participants who achieve a complete response (CR), partial response (PR) or or stable disease (SD) .
Duration of response (DoR)
DoR is defined as the time from the first objective response (CR/PR) to the first documented disease progression (PD) according to RECIST v1.1 or death from any cause, whichever comes first.
Trop2 expression.
Explore the association of trop2 expression with treatment response and prognosis.
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Sichuan University
Lead sponsor
Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.
Collaborator
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Collaborator
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