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New treatment option for Extensive-Stage Small Cell Lung Cancer
Official title Maintenance Lurbinectedin in Combination With Serplulimab for Patients With ES-SCLC
ClinicalTrials.gov ID: NCT06497530
What this study is testing
What is Serplulimab?
Serplulimab is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for extensive-stage small cell lung cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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 first-line induction therapy with carboplatin, etoposide, and Serplulimab. The study consists of 2 phases: an induction phase and a maintenance phase.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- 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...
You likely can't join if
- 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;
See the full eligibility 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...
- Human immunodeficiency virus (HIV)-negative, with no active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Guangzhou, Guangdong, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Guangzhou, Guangdong, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.