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RECRUITING
NCT07759856
PHASE2

NK Cells Plus ICI for SCLC Maintenance

Sponsor: Tianjin First Central Hospital

View on ClinicalTrials.gov

Summary

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.

Official title: A Randomized, Controlled, Open and Exploratory Clinical Trial of Immunization Combined With Allogeneic NK Cells in the Immune Maintenance Stage After First-line Treatment of Extensive Small Cell Lung Cancer

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

42

Start Date

2026-08

Completion Date

2029-08

Last Updated

2026-08-12

Healthy Volunteers

No

Interventions

BIOLOGICAL

Allogeneic Natural Killer Cells

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.

DRUG

Immune Checkpoint Inhibitor

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.

Locations (1)

Tianjin First Central Hospital

Tianjin, Tianjin Municipality, China