AI Cure is a research tool showing open data. Not medical advice. Discuss with your doctor. Terms

← Trials
🧪

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

RecruitingPhase 1Ages 18 Years - 80 YearsAllPeking University Cancer Hospital & Institute
💬

In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
Inclusion Criteria: 1. Patients must have the ability to understand and sign an approved informed consent form (ICF). 2. Patients must be \>= 18 and \<=80 years of age. 3. Extensive-stage small cell lung cancer that requires histopathological or cytological confirmation. 4. Presence of at least 1 measurable site of disease (based on RECIST 1.1). 5. ECOG score of 0 or 1. 6. SSTR-PET positive. 7. 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. 8. 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. Exclusion Criteria: 1. Pregnant or lactating females. 2. Received systemic antitumor therapy such as targeted therapy, immunotherapy, antitumor herbal therapy, chemotherapy within 4 weeks prior to initiation of study treatment. 3. Uncontrolled congestive heart failure. 4. uncontrolled diabetes mellitus, including baseline fasting glucose \> 2 x ULN. 5. Known hypersensitivity to Lutetium\[177Lu\] Oxodotreotide Injection or \[225Ac\]Ac-DOTATATE Injection and their excipients. 6. 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. 7. Unsuitable for the study for any reason, in the opinion of the investigator.
💊

What it tests

  • [225Ac]Ac-DOTATATE
📍

Where

1 site
Peking University Cancer Hospital & Institute
Beijing, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
🛡️

AI Cure shows public evidence (Open Targets, ClinicalTrials.gov, PubMed, openFDA, DepMap, AlphaFold) with its source, and AI summaries that cite it — not medical advice and not a cure. Treatment decisions belong with your doctor. Research ideas are shared only with approved researchers and labs, who can test them. In an emergency call your local emergency number (112 in India and Europe, 911 in the US). AI Cure Terms of Use · Privacy