Health TrialsbyHealthPanel

NK Cells Plus ICI for SCLC Maintenance

ConditionSmall Cell Lung Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorTianjin First Central Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

1: Male or female, aged 18 years or above

Disqualifiers

1:Participate in other clinical trials or use other research drugs or equipment within 4 weeks of the first treatment.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Allogeneic Natural Killer Cells

    Biological/Vaccine

    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 Inhibitor

    Drug

    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.

Treatment groups

42 Participants
are divided into 2 treatment groups
Group A: ICI + Allogeneic NK CellsExperimental treatment 2 interventions
Group B: ICI AloneActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Progression free survival

Time frame
Every 6 weeks from randomization until disease progression or death, up to approximately 24 months
2

Duration of Overall Response

Time frame
From first documented response to disease progression, assessed every 6 weeks up to 24 months
3

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

Secondary outcomes

1

overall survival

Time frame
From randomization to death from any cause, assessed up to 24 months
2

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
3

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
4

Change from baseline in serum tumor markers (SCC) at Day 90

Time frame
Baseline and Day 90

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Tianjin First Central Hospital

Lead sponsor

Source ClinicalTrials.gov
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