Maintenance lurbinectedin with serplulimab after first-line therapy for extensive-stage small cell lung cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a phase 2, single-arm, open-label study evaluating maintenance therapy with lurbinectedin plus serplulimab following an induction course of carboplatin, etoposide, and serplulimab in ES-SCLC. Eligible participants must have achieved response or stable disease by RECIST 1.1 after 4 induction cycles. The trial has an induction phase and a maintenance phase, with the maintenance period receiving the combination therapy. Primary goals focus on safety and preliminary efficacy in the maintenance setting, using standard oncologic criteria to monitor response and progression.

Why it matters

Who can join: the full rules

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.

Where it's running

• The first affiliated hospital of Guangzhou medical university
  Guangzhou, Guangdong, China Recruiting

Study contacts

• Principal investigator: chengzhi Zhou, MD — Guangzhou Institute of Respiratory Disease
• Study coordinator: Ming Liu, MD
• Email: mingliu128@hotmail.com
• Phone: +0086 186 8838 0929

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.