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NCT07413042RecruitingPhase 1

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

Source: ClinicalTrials.gov · Last updated 17 Feb 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Phase (registry)
Phase 1
Study type
Interventional
Enrollment
24 (estimated)
First submitted
18 Jan 2026
Start date
20 Jan 2026
Primary completion date
31 Dec 2026
Lead sponsor
Peking University Cancer Hospital & Institute
Diseases
Lung cancer
NCT number
NCT07413042

What you commit to

  • Study type: Interventional · Phase 1
  • Planned participants: 24
  • From 20 Jan 2026 to the primary completion date, 31 Dec 2026
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Received systemic antitumor therapy such as targeted therapy, immunotherapy, antitumor herbal therapy, chemotherapy within 4 weeks prior to initiation of study treatment.

Other illness

  • Uncontrolled congestive heart failure.
  • Known hypersensitivity to Lutetium\[177Lu\] Oxodotreotide Injection or \[225Ac\]Ac-DOTATATE Injection and their excipients.
  • 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.

Lab values

  • uncontrolled diabetes mellitus, including baseline fasting glucose \> 2 x ULN.

Other

  • Pregnant or lactating females.
  • Unsuitable for the study for any reason, in the opinion of the investigator.

Who the study is looking for

  • Patients must have the ability to understand and sign an approved informed consent form (ICF).
  • Patients must be \>= 18 and \<=80 years of age.
  • Extensive-stage small cell lung cancer that requires histopathological or cytological confirmation.
  • Presence of at least 1 measurable site of disease (based on RECIST 1.1).
  • ECOG score of 0 or 1.
  • SSTR-PET positive.
  • 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.
  • 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.

Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Peking University Cancer Hospital & Institute
Coordinator of this site? Confirm its status
BeijingChinaRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.