Actively Recruiting
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
Led by Peking University Cancer Hospital & Institute · Updated on 2026-02-17
24
Participants Needed
1
Research Sites
127 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to understand and sign informed consent
- Age 18 to 80 years
- Confirmed extensive-stage small cell lung cancer by histopathology or cytology
- At least one measurable disease site based on RECIST 1.1
- ECOG performance status of 0 or 1
- Positive somatostatin receptor PET scan
- Adequate bone marrow and organ function including serum creatinine 1.5 times upper limit of normal or creatinine clearance 50 ml/min, hemoglobin 90 g/L, neutrophils 1.5 x 10^9/L, platelets 100 x 10^9/L, bilirubin 1.5 times ULN, albumin 30 g/L, ALT or AST 2.5 times ULN or 5 times ULN with liver metastases, and APTT 1.5 times ULN
- Use of effective contraception during treatment and for 6 months after last dose if of childbearing potential
You will not qualify if you...
- Pregnant or breastfeeding females
- Received systemic antitumor therapies (targeted, immunotherapy, herbal, chemotherapy) within 4 weeks before study treatment
- Uncontrolled congestive heart failure
- Uncontrolled diabetes with fasting glucose over twice the upper limit of normal
- Known allergy to Lutetium[177Lu] Oxodotreotide Injection, [225Ac]Ac-DOTATATE Injection, or their ingredients
- Investigator believes other treatments are more suitable based on disease characteristics
- Any other reason deemed unsuitable by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Peking University Cancer Hospital & Institute
Beijing, Beijing Municipality, China, 100000
Actively Recruiting
Research Team
Z
Zhi Yang
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
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