Status:
NOT_YET_RECRUITING
Maintenance Lurbinectedin in Combination With Serplulimab for Patients With ES-SCLC
Lead Sponsor:
Guangzhou Institute of Respiratory Disease
Conditions:
Extensive-Stage Small Cell Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This is a single-arm, open-lable exploratory study of Lurbinectedin in combination with Serplulimab as maintenance therapy in participants with extensive-stage small-cell lung cancer (ES-SCLC) after f...
Eligibility Criteria
Inclusion
- Inclusion Criteria for the Induction Phase:
- Fully informed about the study and voluntarily signed a written informed consent form, and able to comply with the requirements and restrictions listed in the informed consent form;
- Male or female with age ≥ 18 years;
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-1;
- Histologically or cytologically confirmed diagnosis of extensive-stage small cell lung cancer (ES-SCLC) and has not received any systemic treatment for ES-SCLC;
- At least one measurable lesion (according to RECIST 1.1 criteria);
- Having adequate bone marrow, hepatic, renal and metabolic function, meaning the functional level of the organs meets the following requirements:
- Platelet count (PLT) ≥ 100×10\^9/L; Hemoglobin (Hb) ≥ 90 g/L; Absolute neutrophil count (ANC) ≥ 2.0×10\^9/L;
- Regardless of whether liver metastasis is present, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3.0×upper limit of normal (ULN);
- Alkaline phosphatase (ALP) ≤ 5×ULN;
- Total bilirubin (TBIL) ≤ 1.5×ULN, and direct bilirubin ≤ 1.0×ULN;
- Serum creatinine ≤ 1.5×ULN or creatinine clearance rate ≥ 30 mL/min (calculated using the Cockcroft-Gault formula);
- Creatine phosphokinase (CPK) ≤ 2.5×ULN;
- Albumin ≥ 3.0 g/dL.
- Women of childbearing potential(WOCBP) must have a negative serum pregnancy test before enrollment. WOCBP must use effective contraceptive measure during the trial drug treatment and for 6 months after the last administration. Male patients (with partners of WOCBP) must use effective contraceptive measure during the trial drug treatment and for 4 months after the last administration;
- Human immunodeficiency virus (HIV)-negative, with no active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection.
- Exclusion Criteria for the Induction Phase:
- Have a history of central nervous system (CNS) metastasis or related history;
- Have a history of active autoimmune disease or immunodeficiency, or related history;
- Have a history of malignancies other than SCLC within 5 years before enrollment;
- Previous treatment with immune checkpoint inhibitors or lurbinectedin;
- Have a history of idiopathic pulmonary fibrosis or pneumonia, or active pneumonia detected in CT screening;
- Treatment with any other investigational product within 28 days before enrollment.
- Inclusion Criteria for the Maintenance Phase:
- Have a continuous response or stable disease according to RECIST 1.1 criteria after 4 cycles of induction therapy;
- Toxicity from the induction therapy phase has recovered to ≤ Grade 1;
- Have sufficient bone marrow and organ function.
- Exclusion Criteria for the Maintenance Phase:
- Have a history of central nervous system (CNS) metastasis or related history;
- Has received chest consolidation radiotherapy;
- Severe infection within 2 weeks before enrollment.
Exclusion
Key Trial Info
Start Date :
August 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT06497530
Start Date
August 1 2024
End Date
December 1 2025
Last Update
July 12 2024
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