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RECRUITING
NCT07413042
PHASE1

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

View on ClinicalTrials.gov

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

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