Sacituzumab Tirumotecan Plus Anlotinib in Previously Treated ES-SCLC
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorChina Medical University, China
About this trial
This is a Phase II, single-arm, open-label clinical study to evaluate the efficacy and safety of Sacituzumab Tirumotecan (SKB264) combined with Anlotinib in patients with extensive-stage small cell lung cancer (ES-SCLC). The study is designed for patients who have experienced disease progression or treatment failure after prior first-line therapy with a PD-(L)1 inhibitor combined with platinum-based doublet chemotherapy. The primary hypothesis is that this combination therapy will improve the objective response rate compared to historical controls.
Eligibility criteria
Qualifiers
Age ≥18 years at the time of signing informed consent; male or female.
Histologically or cytologically confirmed extensive-stage small cell lung cancer (ES-SCLC).
Disease progression after receiving only one prior line of therapy consisting of a PD-(L)1 inhibitor combined with platinum-based doublet chemotherapy.
At least one measurable target lesion per RECIST v1.1 as assessed by the investigator, which has not been previously irradiated.
Disqualifiers
Participation in another interventional drug clinical trial within 4 weeks prior to enrollment.
Tumors with a high risk of massive hemoptysis, as judged by the investigator.
Prior systemic anti-tumor therapy with anti-angiogenic agents.
Prior treatment with TROP2-targeted therapies and/or topoisomerase I inhibitors.
Trial design
Treatments tested in this trial
- Sacituzumab Tirumotecan
- Anlotinib
Treatment groups
30 Participants
are divided into 1 treatment groupLocations
Sponsors and collaborators
Source ClinicalTrials.gov