Phase I Study of 225AcAc-DOTATATE Injection with Tislelizumab for Maintenance Treatment in Extensive-Stage Small Cell Lung Cancer ES-SCLC Patients with Somatostatin Receptors SSTR

What this Trial Is About

Researchers are evaluating the safety and early effectiveness of 225AcAc-DOTATATE injection combined with tislelizumab as maintenance treatment for patients with extensive-stage small cell lung cancer ES-SCLC who have somatostatin receptors SSTR. The study is a phase I trial enrolling patients who have completed first-line induction therapy but have not yet started maintenance treatment. Participants receive tislelizumab at a fixed dose of 200 mg every 3 weeks. The 225AcAc-DOTATATE injection is given once every 6 1 weeks, up to a maximum of 4 doses. The dose escalation phase uses a 33 design with two dose groups 90 kBqkg and 120 kBqkg, followed by a dose expansion phase where participants receive the recommended phase 2 dose RP2D. During the study, researchers assess treatment effects at 6 and 12 months after the last dose, focusing on efficacy and safety. Participants undergo various evaluations including imaging to confirm measurable disease and lab tests to monitor organ function and blood counts. Safety is monitored for at least 6 months after treatment. The total participation duration varies but includes follow-up for key outcome measures after treatment completion.

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