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

NCT ID: NCT06497530

Last Updated: 2024-07-12

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-08-31
• Study Completion Date: 2025-12-31

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 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.

Conditions

Extensive-Stage Small Cell Lung Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Serplulimab

Intervention Type: DRUG

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.

Lurbinectedin

Intervention Type: DRUG

Lurbinectedin will be administered intravenously at a fixed dose of 4 mg on Day 1 of each 21-day cycle in the maintenance phase.

Carboplatin

Intervention Type: DRUG

Carboplatin will be administered according to the standard of care treatment for 4 cycles in the induction phase.

Etoposide

Intervention Type: DRUG

Etoposide will be administered according to the standard of care treatment for 4 cycles in the induction phase.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

Carboplatin

Carboplatin will be administered according to the standard of care treatment for 4 cycles in the induction phase.

Intervention Type: DRUG

Etoposide

Etoposide will be administered according to the standard of care treatment for 4 cycles in the induction phase.

Intervention Type: DRUG

Other Intervention Names

PM01183

Eligibility Criteria

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;
• 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.

• 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

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Guangzhou Institute of Respiratory Disease

OTHER

Sponsor Role: lead

Responsible Party

Zhou Chengzhi

Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

chengzhi Zhou, MD

Role: PRINCIPAL_INVESTIGATOR

Guangzhou Institute of Respiratory Disease

Central Contacts

Ming Liu, MD

Role: CONTACT

mingliu128@hotmail.com

+0086 186 8838 0929

Other Identifiers

CROC-24-02

Identifier Type: -

Identifier Source: org_study_id