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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| [225Ac]Ac-DOTATATE | Experimental | The subjects received the [225Ac]Ac-DOTATATE injection combined with tislelizumab. The tislelizumab was administered at a fixed dose of 200mg on day 1, and was given every 3 weeks. The [225Ac]Ac-DOTATATE injection was administered once every 6 (±1) weeks, with a maximum of 4 administrations. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| [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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Incidence and severity of adverse events (AEs) DLT MTD RP2D | 6 months after last dose administration |
| 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. | PFS | 12 months after last dose administration |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | PFS | 12 months after last dose administration |
| 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. |
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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:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zhi Yang | Contact | 010-88196196 | pekyz@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University Cancer Hospital & Institute | Recruiting | Beijing | Beijing Municipality | 100000 | China |
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ORR |
| 12 months after last dose administration |
| 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. | DCR | 12 months after last dose administration |
| 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. | OS | 12 months after last dose administration |
| During the dose expansion phase, other efficacy endpoint indicators will be evaluated. | PFS since the first-line treatment | 12 months after last dose administration |
| During the dose expansion phase, other efficacy endpoint indicators will be evaluated. | ORR | 12 months after last dose administration |
| During the dose expansion phase, other efficacy endpoint indicators will be evaluated. | DCR | 12 months after last dose administration |
| During the dose expansion phase, other efficacy endpoint indicators will be evaluated. | OS | 12 months after last dose administration |
| During the dose expansion phase, the safety is evaluated. | Incidence and severity of adverse events (AEs) | 6 months after last dose administration |