NCT06497530 Maintenance Lurbinectedin in Combination With Serplulimab for Patients With ES-SCLC
| NCT ID | NCT06497530 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Guangzhou Institute of Respiratory Disease |
| Condition | Extensive-Stage Small Cell Lung Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2024-12-01 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 30 participants in total. It began in 2024-12-01 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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.
Contact & Investigator
chengzhi Zhou, MD
PRINCIPAL INVESTIGATOR
Guangzhou Institute of Respiratory Disease
Frequently Asked Questions
Who can join the NCT06497530 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Extensive-Stage Small Cell Lung Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06497530 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06497530 currently recruiting?
Yes, NCT06497530 is actively recruiting participants. Contact the research team at mingliu128@hotmail.com for enrollment information.
Where is the NCT06497530 trial being conducted?
This trial is being conducted at Guangzhou, China.
Who is sponsoring the NCT06497530 clinical trial?
NCT06497530 is sponsored by Guangzhou Institute of Respiratory Disease. The principal investigator is chengzhi Zhou, MD at Guangzhou Institute of Respiratory Disease. The trial plans to enroll 30 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.