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

NCT06497530 | Not Yet Recruiting Phase 2 DMC

• 1 other identifier: CROC-24-02
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• Progression-Free Survival (PFS)

  progression-free survival (PFS) is defined as the time from treatment initiation to the date of first documented disease progression (as assessed according to RECIST v1.1) or death whichever occurs first.

  Treatment initiation to the date of first documented disease progression or death whichever occurs first (up to approximately 24 months)

Secondary Outcomes (4)

• Overall Survival (OS)

  Treatment initiation to the date of death from any cause(up to approximately 24 months)

• Objective Response Rate (ORR)

  up to approximately 24 months

• Duration of Response (DOR)

  up to approximately 24 months

• Percentage of Participants With Adverse Events

  up to approximately 24 months

Study Arms (1)

Experimental Treatment

EXPERIMENTAL

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: Serplulimab; Drug: Lurbinectedin; Drug: Carboplatin; Drug: Etoposide

Interventions

Serplulimab 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.

Experimental Treatment

Lurbinectedin 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.

Also known as: PM01183

Experimental Treatment

Carboplatin DRUG

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

Experimental Treatment

Etoposide DRUG

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

Experimental Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Guangzhou Institute of Respiratory Disease: lead

MeSH Terms

Conditions

Small Cell Lung Carcinoma

Interventions

PM 01183; Carboplatin; Etoposide

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds; Glucosides; Glycosides; Carbohydrates

Study Officials

• chengzhi Zhou, MD

  Guangzhou Institute of Respiratory Disease

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ming Liu, MD

CONTACT

+0086 186 8838 0929; mingliu128@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: July 5, 2024
• First Posted: July 11, 2024
• Study Start: August 1, 2024
• Primary Completion: June 1, 2025
• Study Completion: December 1, 2025
• Last Updated: July 12, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share