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Taking people in ChinaPhase 2

Tests lurbinectedin with serplulimab as maintenance treatment for small cell lung cancer

Tests lurbinectedin plus serplulimab in adults with extensive-stage small cell lung cancer.

Key facts

Who runs it
Guangzhou Institute of Respiratory Disease
Where
Guangzhou, ChinaSee the site
Trial code
Registry title
Maintenance Lurbinectedin in Combination With Serplulimab for Patients With ES-SCLC
Status
Recruiting
Phase
Phase 2
People taking part
30 people, planned
Started
1 Dec 2024
Expected to end
Dec 2026
Type of study
Interventional
Treatments tested
  • Serplulimab
  • Lurbinectedin
  • Carboplatin
  • Etoposide
Record updated
8 June 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with extensive-stage small cell lung cancer who have not had treatment for it yet. After 4 cycles of first treatment, those whose cancer responded or stayed stable can go on to maintenance treatment.

Age
18 years or older
Sex
Men and women can join
Disease stage
Extensive-stage small cell lung cancer, confirmed by tissue or cell tests, with at least one measurable tumour. For maintenance: a continuing response or stable disease after 4 cycles of induction treatment.
Earlier treatment
No earlier systemic treatment for extensive-stage small cell lung cancer. No earlier immune checkpoint inhibitor or lurbinectedin. For maintenance: side effects from induction treatment must have recovered to Grade 1 or milder.
Biomarker or test result
HIV-negative, with no active hepatitis B or hepatitis C infection. Blood counts, liver, kidney and metabolic tests must be within set limits.

Main reasons for not taking part

  • History of cancer spread to the brain or central nervous system
  • Active autoimmune disease or immune deficiency, now or in the past
  • Another cancer (not small cell lung cancer) within the last 5 years
  • History of idiopathic pulmonary fibrosis or pneumonia, or active pneumonia on CT scan
  • Another investigational product within 28 days before enrollment

The registry criteria, word for word

Show all 27 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • Previous treatment with immune checkpoint inhibitors or lurbinectedin
  • Treatment with any other investigational product within 28 days before enrollment
  • Has received chest consolidation radiotherapy
  • Severe infection within 2 weeks before enrollment
  • 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
  • Have a history of idiopathic pulmonary fibrosis or pneumonia, or active pneumonia detected in CT screening
  • Have a history of central nervous system (CNS) metastasis or related history

Where in China

  • The First Affiliated Hospital of Guangzhou Medical UniversityGuangzhou, ChinaContact: Liu, DoctorTaking people

About the trial

What the trial wants to find out

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.

The group in the trial

  • Experimental TreatmentTreatment being tested

    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.

    Treatment: Serplulimab, Lurbinectedin, Carboplatin, and Etoposide

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
An Exploratory Study of Maintenance Lurbinectedin in Combination With Serplulimab for Patients With Extensive-Stage Small Cell Lung Cancer
Plain-language title
Tests lurbinectedin with serplulimab as maintenance treatment for small cell lung cancerGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Record updated
8 June 2026