This research study is designed for patients with extensive-stage small cell lung cancer (ES-SCLC) who have already received four cycles of standard chemotherapy, with at least two cycles combined with immunotherapy, and have achieved disease control (stable disease, partial response, or complete response) at their last efficacy evaluation. In this study, participants will be randomly assigned to one of two groups: Group A will receive standard immunotherapy plus 1 to 3 courses of allogeneic natural killer (NK) cell therapy. Each course consists of six NK cell infusions given over 28 days. Group B will receive standard immunotherapy alone. All participants will continue treatment until their disease progresses or they experience unacceptable side effects. The immunotherapy agents used in this study are those recommended by major international and national clinical guidelines for extensive-stage SCLC, including but not limited to durvalumab, atezolizumab, serplulimab, and adebrelimab. The purpose of this study is to evaluate whether adding NK cell therapy to standard immunotherapy can provide additional benefits for patients with extensive-stage SCLC who have responded well to initial treatment.
This is a prospective study enrolling 42 patients with extensive-stage small cell lung cancer (ES-SCLC) who have completed four cycles of platinum-based doublet chemotherapy, with at least two cycles of immunotherapy combined with platinum-based doublet chemotherapy, and whose final efficacy assessment after the last cycle shows disease control (SD, PR, or CR). Patients will be adaptively randomized into two groups based on the results of prior efficacy analysis. Subjects will be randomly assigned to Group A or Group B. Patients in Group A will receive an immune checkpoint inhibitor (ICI) plus 1-3 courses of allogeneic natural killer (NK) cell therapy. One course of NK cell therapy is designed to consist of two cycles, with a total of six NK cell infusions within 28 days, specifically on Days 12, 13, and 14 of the first cycle and Days 26, 27, and 28 of the second cycle. In addition, on Day 1 of each 21-day cycle, patients will receive standard-of-care treatment with intravenous infusion of an immune checkpoint inhibitor. Patients in Group B will receive standard-of-care treatment with intravenous infusion of an immune checkpoint inhibitor on Day 1 of each 21-day cycle, and treatment will continue until disease progression or unacceptable toxicity occurs. After signing the written informed consent form, patients will receive study treatment per protocol until disease progression or intolerable adverse events develop. The immune checkpoint inhibitors used in this study are those recommended for extensive-stage SCLC in the NCCN, ESMO, and CSCO guidelines, including but not limited to durvalumab, atezolizumab, serplulimab, and adebrelimab.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
42
Allogeneic NK cells derived from healthy donors, expanded and activated ex vivo. One course consists of two cycles with 6 IV infusions over 28 days: Days 12, 13, 14 (Cycle 1) and Days 26, 27, 28 (Cycle 2). Patients receive 1-3 courses.
Immune checkpoint inhibitors recommended for extensive-stage SCLC by NCCN, ESMO, and CSCO guidelines, including but not limited to durvalumab, atezolizumab, serplulimab, adebrelimab, and toripalimab. Administered as IV infusion on Day 1 of each 21-day cycle.
Tianjin First Central Hospital
Tianjin, Tianjin Municipality, China
RECRUITINGProgression free survival
Time frame: Every 6 weeks from randomization until disease progression or death, up to approximately 24 months
Duration of Overall Response
Time frame: From first documented response to disease progression, assessed every 6 weeks up to 24 months
Incidence and Severity of Treatment-Emergent Adverse Events (TEAEs)
Time frame: From first dose through 30 days after last dose, up to approximately 24 months
overall survival
Time frame: From randomization to death from any cause, assessed up to 24 months
Change from baseline in peripheral blood lymphocyte subsets (CD3+CD4+, CD3+CD8+, total CD3+, CD3-CD19+, and CD3-CD16+CD56+ cells) at Day 90
Time frame: Baseline and Day 90
Change from baseline in serum cytokine levels (IL-2, IL-4, IL-6, IL-10, TNF-β, and IFN-γ) at Day 90
Time frame: Baseline and Day 90
Change from baseline in serum tumor markers (SCC) at Day 90
Time frame: Baseline and Day 90
Change from baseline in peripheral blood NK cell activity at Day 90
Time frame: Baseline and Day 90
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.