NK Cells Plus ICI for SCLC Maintenance

Sponsor
Tianjin First Central Hospital
Study ID
NCT07759856
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Allogeneic Natural Killer Cells — BIOLOGICAL
    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.

Study Details

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.

Key Dates

First listed
Aug 12, 2026
Start date
Aug 31, 2026
Status verified
Aug 2026
Primary completion
Aug 31, 2028
Completion
Aug 31, 2029

Study Design

Enrollment
42 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: ICI + Allogeneic NK Cells
  • Active Comparator: ICI Alone

Primary Outcome Measure

Progression free survival [ Time Frame: Every 6 weeks from randomization until disease progression or death, up to approximately 24 months ]

Central Contacts

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