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Maintenance Lurbinectedin in Combination With Serplulimab for Patients With ES-SCLC | Clinical Trials | Clareo Health

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Maintenance Lurbinectedin in Combination With Serplulimab for Patients With ES-SCLC

An Exploratory Study of Maintenance Lurbinectedin in Combination With Serplulimab for Patients With Extensive-Stage Small Cell Lung Cancer

NCT06497530•Guangzhou Institute of Respiratory Disease

View on ClinicalTrials.gov

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 first-line induction therapy with carboplatin, etoposide, and Serplulimab. The study consists of 2 phases: an induction phase and a maintenance phase. Participants need to have an ongoing response or stable disease per the Response Evaluation Criteria in Solid Tumor (RECIST) v1.1 criteria after completion of 4 cycles of carboplatin, etoposide, and Serplulimab induction treatment in order to be considered for eligibility screening for the maintenance phase. Eligible participants will receive lurbinectedin plus Serplulimab in the maintenance phase.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•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;
+8 more criteria

Exclusion Criteria

•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.
•Have a history of central nervous system (CNS) metastasis or related history;
•Has received chest consolidation radiotherapy;
•Severe infection within 2 weeks before enrollment.

Key Dates

Start Date

August 1, 2024

Primary Completion Date

June 1, 2025

Completion Date

December 1, 2025

Last Updated

July 12, 2024

Enrollment

ESTIMATED participants

Conditions

Extensive-Stage Small Cell Lung Cancer

Interventions

Serplulimab

DRUG

Lurbinectedin

DRUG

Carboplatin

DRUG

Etoposide

DRUG

Contacts

Ming Liu, MD

CONTACT

+0086 186 8838 0929 mingliu128@hotmail.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 12, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Maintenance Lurbinectedin in Combination With Serplulimab for Patients With ES-SCLC

Inclusion Criteria

Exclusion Criteria

A Study to Compare the Efficacy and Safety of BMS-986489 (BMS-986012+ Nivolumab Fixed Dose Combination) in Combination With Carboplatin Plus Etoposide to That of Atezolizumab With Carboplatin Plus Etoposide as First-Line Therapy in Participants With Extensive-Stage Small Cell Lung Cancer (TIGOS).

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