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A Phase I Study to Evaluate the Safety and Preliminary Efficacy of [225Ac]Ac-DOTATATE Injection Combined With Tislelizumab in the Maintenance Treatment Period for Patients of Extensive-stage Small Cell Lung Cancer (ES-SCLC) With Somatostatin Receptors (SSTR)+ as First-line Treatment
Sponsor: Peking University Cancer Hospital & Institute
Summary
This is a phase I study to evaluate the safety and preliminary efficacy of \[225Ac\]Ac-DOTATATE injection combined with tislelizumab in the maintenance treatment period for patients of extensive-stage small cell lung cancer (ES-SCLC) with somatostatin receptors (SSTR)+ as first-line treatment.Patients with ES-SCLC who have completed the induction therapy of first-line standard treatment and are yet to enter the maintenance treatment period are planned to be enrolled.
Key Details
Gender
All
Age Range
18 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
24
Start Date
2026-01-20
Completion Date
2028-06-30
Last Updated
2026-02-17
Healthy Volunteers
No
Conditions
Interventions
[225Ac]Ac-DOTATATE
During the dose escalation phase, the "3+3" dose escalation method was adopted. There were two dose groups: the single-dose administration dose of the first dose group was 90 kBq/kg, and that of the second dose group was 120 kBq/kg.During the dose expansion phase, the subjects received the RP2D dose of the \[225Ac\]Ac-DOTATATE injection. The administration method, combination therapy, etc. were all the same as those in the dose escalation phase.
Locations (1)
Peking University Cancer Hospital & Institute
Beijing, Beijing Municipality, China