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

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.

Study Overview

• Status: Recruiting
• Conditions: Extensive-Stage Small Cell Lung Cancer
• Intervention / Treatment: Drug: Carboplatin; Drug: Etoposide; Drug: Serplulimab; Drug: Lurbinectedin

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Ming Liu, MD; Phone Number: +0086 186 8838 0929; Email: mingliu128@hotmail.com

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 51000
      • Recruiting
      • The First Affiliated Hospital of Guangzhou Medical University
      • Contact: Liu, Doctor; Phone Number: 020-81566477; Email: mingliu128@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Experimental Treatment; Induction phase：participants will receive Serplulimab on Day 1 of each 21-day cycle in combination with carboplatin on Day 1 and etoposide on Days 1, 2, and 3 of each 21-day cycle for 4 cycles. Maintenance phase：participants will receive Serplulimab on Day 1 of each 21-day cycle in combination with Lurbinectedin on Day 1 of each 21-day cycle.

Drug: Carboplatin; Carboplatin will be administered according to the standard of care treatment for 4 cycles in the induction phase.; Drug: Etoposide; Etoposide will be administered according to the standard of care treatment for 4 cycles in the induction phase.; Drug: Serplulimab; Serplulimab will be administered intravenously at a dose of 4.5 mg/kg on Day 1 of each 21-day cycle for 4 cycles in the induction phase. Serplulimab will be administered intravenously at a dose of 4.5 mg/kg on Day 1 of each 21-day cycle in the maintenance phase.; Drug: Lurbinectedin; Lurbinectedin will be administered intravenously at a fixed dose of 4 mg on Day 1 of each 21-day cycle in the maintenance phase.; Other Names: PM01183

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression-Free Survival (PFS)	progression-free survival (PFS) is defined as the time from the initiation of maintenance therapy to the date of first documented disease progression (as assessed according to RECIST v1.1) or death whichever occurs first.	Initiation of maintenance therapy to the date of first documented disease progression or death whichever occurs first (up to approximately 24 months)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Objective Response Rate (ORR)	Objective response rate (ORR) is defined as the proportion of participants with a complete response（CR） or partial response（PR） according to RECIST v1.1.	up to approximately 24 months
Duration of Response (DOR)	Duration of Response (DOR) (for participants with a confirmed objective response) is defined as the time from the first occurrence of a documented confirmed objective response until disease progression according to RECIST v1.1 or death from any cause, whichever occurs first.	up to approximately 24 months
Percentage of Participants With Adverse Events	Percentage of participants with adverse events	up to approximately 24 months
Overall Survival (OS)	Overall survival (OS) is defined as the time from the initiation of maintenance therapy to the date of death from any cause.	Initiation of maintenance therapy to the date of death from any cause (up to approximately 24 months)

Collaborators and Investigators

• Sponsor: Guangzhou Institute of Respiratory Disease
• Investigators: Principal Investigator: chengzhi Zhou, MD, Guangzhou Institute of Respiratory Disease

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: July 5, 2024
• First Submitted That Met QC Criteria: July 5, 2024
• First Posted (Actual): July 11, 2024

Study Record Updates

• Last Update Posted (Actual): June 8, 2026
• Last Update Submitted That Met QC Criteria: June 4, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Lung Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Small Cell Lung Carcinoma; Organic Chemicals; Hydrocarbons; Hydrocarbons, Cyclic; Carbohydrates; Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Polycyclic Compounds; Glucosides; Glycosides; Coordination Complexes; Etoposide; Carboplatin; PM 01183
• Other Study ID Numbers: CROC-24-02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data (IPD) will not be shared

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No