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
78 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and early effectiveness of [225Ac]Ac-DOTATATE injection combined with tislelizumab as maintenance treatment for patients with extensive-stage small cell lung cancer (ES-SCLC) who have somatostatin receptors (SSTR)+. The study is a phase I trial enrolling patients who have completed first-line induction therapy but have not yet started maintenance treatment. Participants receive tislelizumab at a fixed dose of 200 mg every 3 weeks. The [225Ac]Ac-DOTATATE injection is given once every 6 (±1) weeks, up to a maximum of 4 doses. The dose escalation phase uses a 3+3 design with two dose groups (90 kBq/kg and 120 kBq/kg), followed by a dose expansion phase where participants receive the recommended phase 2 dose (RP2D). During the study, researchers assess treatment effects at 6 and 12 months after the last dose, focusing on efficacy and safety. Participants undergo various evaluations including imaging to confirm measurable disease and lab tests to monitor organ function and blood counts. Safety is monitored for at least 6 months after treatment. The total participation duration varies but includes follow-up for key outcome measures after treatment completion.
CONDITIONS
Brief 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 form
- Age 18 to 80 years
- Histopathological or cytological confirmation of extensive-stage small cell lung cancer
- At least one measurable disease site based on RECIST 1.1
- ECOG performance status of 0 or 1
- Positive somatostatin receptor PET scan (SSTR-PET)
- Adequate bone marrow and organ function including specified blood counts and liver/kidney parameters
- Use of effective contraception if of childbearing potential during treatment and for 6 months after last dose
You will not qualify if you...
- Pregnant or breastfeeding women
- Received systemic anti-cancer therapies (targeted, immunotherapy, chemotherapy, or herbal) within 4 weeks before study treatment
- Uncontrolled congestive heart failure
- Uncontrolled diabetes with fasting glucose greater than twice the upper limit of normal
- Known allergy to Lutetium[177Lu] Oxodotreotide Injection, [225Ac]Ac-DOTATATE Injection, or their ingredients
- Other treatment options deemed more appropriate by the investigator
- Any condition making the participant unsuitable for the study as judged by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to approximately 24 weeks
Participants receive [225Ac]Ac-DOTATATE injections combined with tislelizumab during the maintenance treatment period. Tislelizumab is administered at a fixed dose every 3 weeks, and [225Ac]Ac-DOTATATE injections are given once every 6 (±1) weeks, with up to 4 administrations.
Visits every 3 weeks for tislelizumab and every 6 (±1) weeks for [225Ac]Ac-DOTATATE administration, up to 4 doses
Duration - 6 to 12 months after last dose administration
Participants are monitored for safety and efficacy outcomes following the last dose administration.
Visits at intervals during the follow-up period up to 12 months
Trial Site Locations
Total: 1 location
1
Peking University Cancer Hospital & Institute
Beijing, Beijing Municipality, China, 100000
Actively Recruiting
Research Team
Z
Zhi Yang
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here