RecruitingPhase 1NCT07413042

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

Enrollment

24 participants

Start Date

Jan 20, 2026

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether a targeted radioactive treatment called [225Ac]Ac-DOTATATE, combined with the immunotherapy drug tislelizumab, is safe and shows early signs of effectiveness as a maintenance therapy for people with extensive-stage small cell lung cancer (ES-SCLC) whose tumors express a certain receptor (SSTR) and who responded to initial first-line therapy. **You may be eligible if...** - You are 18 to 80 years old - You have confirmed extensive-stage small cell lung cancer - Your tumor scans are positive for somatostatin receptors (SSTR-PET positive) - Your cancer has at least one measurable site of disease - Your performance status is good (ECOG 0 or 1) - Your blood counts and organ function are within acceptable limits **You may NOT be eligible if...** - You are pregnant or breastfeeding - You have received prior systemic anti-cancer treatment within 4 weeks before starting study treatment - You have uncontrolled heart failure or uncontrolled diabetes - You have a known allergy to the study drugs - Your doctor believes another treatment option is more appropriate for you Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUG[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

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NCT07413042


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