Sacituzumab Tirumotecan in Combination With Anlotinib in Previously Treated Patients With Extensive-Stage Small Cell Lung Cancer (ES-SCLC)
NCT07501169 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 33
Last updated 2026-04-13
Summary
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.
Conditions
- Extensive-stage Small Cell Lung Cancer (ES-SCLC)
Interventions
- DRUG
-
Sacituzumab Tirumotecan and Anlotinib
Treatment 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.
Sponsors & Collaborators
-
Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.
collaborator INDUSTRY -
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
collaborator INDUSTRY -
Sichuan University
lead OTHER
Principal Investigators
-
Jianxin Xue · West China Hospital
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-04-01
- Primary Completion
- 2027-08-31
- Completion
- 2028-12-31
Countries
- China
Study Locations
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