Maintenance treatment with [225Ac]Ac-DOTATATE plus tislelizumab for extensive‑stage small cell lung cancer with somatostatin receptor–positive tumors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a phase I, single‑center, open‑label study enrolling patients with extensive‑stage small cell lung cancer who have completed induction first‑line therapy and whose tumors are SSTR‑PET positive. Participants will receive [225Ac]Ac‑DOTATATE in combination with tislelizumab during the maintenance period, with close monitoring for safety and tolerability. The trial requires at least one measurable lesion per RECIST 1.1 and ECOG 0–1, and collects laboratory, adverse event, and tumor response data to identify preliminary signs of efficacy. Primary focus is on dose‑related and treatment‑related toxicities, with secondary observation of tumor control measures.

Why it matters

Who can join: the full rules

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.

Where it's running

• Peking University Cancer Hospital & Institute
  Beijing, Beijing Municipality, China Recruiting

Study contacts

• Study coordinator: Zhi Yang
• Email: pekyz@163.com
• Phone: 010-88196196

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.