Radioactive drug plus immunotherapy shows promise for tough lung cancer
NCT ID NCT07413042
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-phase study tests a combination of a radioactive drug ([225Ac]Ac-DOTATATE) and an immunotherapy (tislelizumab) as maintenance therapy for people with extensive-stage small cell lung cancer that has a specific marker (SSTR). The goal is to see if this combination is safe and can help keep the cancer from growing after initial treatment. About 24 adults who have finished their first round of standard chemotherapy will participate.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 24 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jan 2026
- Expected to finish
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Jun 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 80 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Peking University Cancer Hospital & Institute
RECRUITINGBeijing, Beijing Municipality, 100000, China
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Other studies related to the condition(s) this trial covers.
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