Peking University Cancer Hospital & Institute
Beijing, Beijing Municipality, 100000, China
Location status: Recruiting
NCT Number: NCT07413042
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.
Interested in participating?
Request Info18 year–80 year
All sexes
Interventional
Phase 1
Beijing, Beijing Municipality, 100000, China
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Serum creatinine ≤1.5×ULN or creatinine clearance ≥50 ml/min (Cockcroft Gault formula).
Hemoglobin≥90g/L, neutrophil count ≥1.5×10^9/L, platelets≥100×10^9/L. Serum total bilirubin ≤1.5×ULN. Serum albumin ≥30g/L. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≤ 2.5×ULN,or ALT/AST≤5×ULN with liver metastases.
Partially activated prothrombin time (APTT) ≤1.5 x ULN.
Exclusion criteria
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.
Time frame: 6 months after last dose administration
Incidence and severity of adverse events (AEs) DLT MTD RP2D
Time frame: 12 months after last dose administration
PFS
Time frame: 12 months after last dose administration
PFS
Time frame: 12 months after last dose administration
ORR
Time frame: 12 months after last dose administration
DCR
Time frame: 12 months after last dose administration
OS
Time frame: 12 months after last dose administration
PFS since the first-line treatment
Time frame: 12 months after last dose administration
ORR
Time frame: 12 months after last dose administration
DCR
Time frame: 12 months after last dose administration
OS
Time frame: 6 months after last dose administration
Incidence and severity of adverse events (AEs)
Contact information is provided by the study sponsor or research team.
Peking University Cancer Hospital & Institute
Other
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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