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NCT Number: NCT07413042

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

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.

Recruiting

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Peking University Cancer Hospital & Institute

Beijing, Beijing Municipality, 100000, China

Location status: Recruiting

Location contact

Zhi Yang

CONTACT

[email protected]

010-88196196

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients must have the ability to understand and sign an approved informed consent form (ICF).
  • Patients must be >= 18 and <=80 years of age.
  • Extensive-stage small cell lung cancer that requires histopathological or cytological confirmation.
  • Presence of at least 1 measurable site of disease (based on RECIST 1.1).
  • ECOG score of 0 or 1.
  • SSTR-PET positive.
  • 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.

  • 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

  • Pregnant or lactating females.
  • Received systemic antitumor therapy such as targeted therapy, immunotherapy, antitumor herbal therapy, chemotherapy within 4 weeks prior to initiation of study treatment.
  • Uncontrolled congestive heart failure.
  • uncontrolled diabetes mellitus, including baseline fasting glucose > 2 x ULN.
  • Known hypersensitivity to Lutetium[177Lu] Oxodotreotide Injection or [225Ac]Ac-DOTATATE Injection and their excipients.
  • 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.
  • Unsuitable for the study for any reason, in the opinion of the investigator.

Treatment and study plan

[225Ac]Ac-DOTATATE

Drug

During the dose escalation phase, the "3+3" dose escalation method was adopted. There were two dose groups: the single-dose administration dose of the first dose group was 90 kBq/kg, and that of the second dose group was 120 kBq/kg.During the dose expansion phase, the subjects received the RP2D dose of the [225Ac]Ac-DOTATATE injection. The administration method, combination therapy, etc. were all the same as those in the dose escalation phase.

Primary outcomes

  1. During the dose escalation phase, the efficacy of [225Ac]Ac-DOTATATE injection at the RP2D dose for maintenance treatment in first-line therapy for SSTR-positive ES-SCLC patients when used in combination with tislelizumab was evaluated.

    Time frame: 6 months after last dose administration

    Incidence and severity of adverse events (AEs) DLT MTD RP2D

  2. During the dose expansion phase, the efficacy of [225Ac]Ac-DOTATATE injection at the RP2D dose for maintenance treatment in first-line therapy for SSTR-positive ES-SCLC patients when used in combination with tislelizumab was evaluated.

    Time frame: 12 months after last dose administration

    PFS

Secondary outcomes

  1. During the dose escalation phase, the efficacy of [225Ac]Ac-DOTATATE injection for use as a maintenance treatment in the first-line therapy of SSTR-positive ES-SCLC patients when combined with tislelizumab was evaluated.

    Time frame: 12 months after last dose administration

    PFS

  2. During the dose escalation phase, the efficacy of [225Ac]Ac-DOTATATE injection for use as a maintenance treatment in the first-line therapy of SSTR-positive ES-SCLC patients when combined with tislelizumab was evaluated.

    Time frame: 12 months after last dose administration

    ORR

  3. During the dose escalation phase, the efficacy of [225Ac]Ac-DOTATATE injection for use as a maintenance treatment in the first-line therapy of SSTR-positive ES-SCLC patients when combined with tislelizumab was evaluated.

    Time frame: 12 months after last dose administration

    DCR

  4. During the dose escalation phase, the efficacy of [225Ac]Ac-DOTATATE injection for use as a maintenance treatment in the first-line therapy of SSTR-positive ES-SCLC patients when combined with tislelizumab was evaluated.

    Time frame: 12 months after last dose administration

    OS

  5. During the dose expansion phase, other efficacy endpoint indicators will be evaluated.

    Time frame: 12 months after last dose administration

    PFS since the first-line treatment

  6. During the dose expansion phase, other efficacy endpoint indicators will be evaluated.

    Time frame: 12 months after last dose administration

    ORR

  7. During the dose expansion phase, other efficacy endpoint indicators will be evaluated.

    Time frame: 12 months after last dose administration

    DCR

  8. During the dose expansion phase, other efficacy endpoint indicators will be evaluated.

    Time frame: 12 months after last dose administration

    OS

  9. During the dose expansion phase, the safety is evaluated.

    Time frame: 6 months after last dose administration

    Incidence and severity of adverse events (AEs)

Study contacts

Contact information is provided by the study sponsor or research team.

Zhi Yang

CONTACT

[email protected]

010-88196196

Sponsors and collaborators

Lead sponsor

Peking University Cancer Hospital & Institute

Other

Registry information

Important dates

Study start
2026
Primary completion
2026
Study completion
2028
First posted
Feb 17, 2026
Registry last updated
Feb 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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