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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
24
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.
Peking University Cancer Hospital & Institute
Beijing, Beijing Municipality, China
RECRUITINGDuring the dose escalation phase, the efficacy of [225Ac]Ac-DOTATATE injection at the RP2D dose for maintenance treatment in first-line therapy for SSTR-positive ES-SCLC patients when used in combination with tislelizumab was evaluated.
Incidence and severity of adverse events (AEs) DLT MTD RP2D
Time frame: 6 months after last dose administration
During the dose expansion phase, the efficacy of [225Ac]Ac-DOTATATE injection at the RP2D dose for maintenance treatment in first-line therapy for SSTR-positive ES-SCLC patients when used in combination with tislelizumab was evaluated.
PFS
Time frame: 12 months after last dose administration
During the dose escalation phase, the efficacy of [225Ac]Ac-DOTATATE injection for use as a maintenance treatment in the first-line therapy of SSTR-positive ES-SCLC patients when combined with tislelizumab was evaluated.
PFS
Time frame: 12 months after last dose administration
During the dose escalation phase, the efficacy of [225Ac]Ac-DOTATATE injection for use as a maintenance treatment in the first-line therapy of SSTR-positive ES-SCLC patients when combined with tislelizumab was evaluated.
ORR
Time frame: 12 months after last dose administration
During the dose escalation phase, the efficacy of [225Ac]Ac-DOTATATE injection for use as a maintenance treatment in the first-line therapy of SSTR-positive ES-SCLC patients when combined with tislelizumab was evaluated.
DCR
Time frame: 12 months after last dose administration
During the dose escalation phase, the efficacy of [225Ac]Ac-DOTATATE injection for use as a maintenance treatment in the first-line therapy of SSTR-positive ES-SCLC patients when combined with tislelizumab was evaluated.
OS
Time frame: 12 months after last dose administration
During the dose expansion phase, other efficacy endpoint indicators will be evaluated.
PFS since the first-line treatment
Time frame: 12 months after last dose administration
During the dose expansion phase, other efficacy endpoint indicators will be evaluated.
ORR
Time frame: 12 months after last dose administration
During the dose expansion phase, other efficacy endpoint indicators will be evaluated.
DCR
Time frame: 12 months after last dose administration
During the dose expansion phase, other efficacy endpoint indicators will be evaluated.
OS
Time frame: 12 months after last dose administration
During the dose expansion phase, the safety is evaluated.
Incidence and severity of adverse events (AEs)
Time frame: 6 months after last dose administration
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