TheranosticTrials.org

Clinical Trial · NCT07413042

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

Overview

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.

Sponsor

Peking University Cancer Hospital & Institute

Phase

Phase 1

Contacts

Zhi Yang (CONTACT)

pekyz@163.com

010-88196196

ClinicalTrials.gov

NCT07413042

Drug / Compound

DOTATATE

Isotope(s):
Target(s):
  • SSTR2
Ligand Class: Peptides
Chelator: DOTA

Eligibility

Inclusion

  • Extensive-stage small cell lung cancer that requires histopathological or cytological confirmation.
  • SSTR-PET positive.
  • Presence of at least 1 measurable site of disease (based on RECIST 1.1).
  • Subjects of childbearing potential voluntarily use an effective method of contraception, such as condoms, oral or injectable contraceptives, IUDs, etc., during treatment and within 6 months of the last use of the trial drug.
  • Sufficient bone marrow capacity and organ function: 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.
  • ECOG score of 0 or 1.

Exclusion

  • Unsuitable for the study for any reason, in the opinion of the investigator.
  • Uncontrolled congestive heart failure.
  • Other treatment options (e.g., chemotherapy, targeted therapy) that, in the opinion of the investigator, are more appropriate for the patient than the treatment provided in the study based on the patient's disease characteristics.
  • Known hypersensitivity to Lutetium\[177Lu\] Oxodotreotide Injection or \[225Ac\]Ac-DOTATATE Injection and their excipients.
  • uncontrolled diabetes mellitus, including baseline fasting glucose \> 2 x ULN.
  • Received systemic antitumor therapy such as targeted therapy, immunotherapy, antitumor herbal therapy, chemotherapy within 4 weeks prior to initiation of study treatment.
  • Pregnant or lactating females.