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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
Sacituzumab Tirumotecan
DrugSacituzumab tirumotecan is an antibody-drug conjugate targeting Trop-2. It will be administered intravenously according to the dosing schedule specified in the study protocol. Treatment will continue until disease progression, unacceptable toxicity, withdrawal of consent, or other protocol-defined discontinuation criteria are met.
Anlotinib
DrugAnlotinib is an oral small-molecule multi-target tyrosine kinase inhibitor. It will be administered orally according to the dosing regimen specified in the study protocol. Treatment will continue until disease progression, unacceptable toxicity, withdrawal of consent, or other protocol-defined discontinuation criteria are met.
Treatment groups
30 Participants
are divided into 1 treatment groupGroup A: Experimental ArmExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Objective Response Rate (ORR)
Objective response rate (ORR) as assessed by the investigator according to RECIST version 1.1, defined as the proportion of patients achieving complete response (CR) or partial response (PR).
Time frame
From the first dose of study treatment until disease progression, intolerance, or start of new anti-cancer therapy, assessed every 6 weeks for the first 12 months and every 12 weeks thereafter, up to approximately 24 months.Secondary outcomes
1
Progression-Free Survival (PFS)
The time from the first dose of study treatment to the first documented disease progression or death from any cause.
Time frame
From the first dose of study treatment until disease progression, intolerance, or start of new anti-cancer therapy, assessed every 6 weeks for the first 12 months and every 12 weeks thereafter, up to approximately 24 months2
Overall Survival (OS)
The time from randomization (or first dose) to death from any cause.
Time frame
From first dose until death, assessed every 6 weeks (Year 1) then every 12 weeks, and every 3 months during survival follow-up, up to approximately 24 months.Locations
Sponsors and contacts
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Source ClinicalTrials.gov
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