Clinical trial · Interventional
NK Cell-based Immunotherapy as Maintenance Therapy for Small-Cell Lung Cancer.
A Randomized, Controlled, Open-label, Single Center, Phase II Study to Evaluate the Efficacy and Safety of NK Cell-based Immunotherapy as Maintenance Therapy for Patients With Small-cell Lung Cancer After First-line Chemotherapy.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Natural killer (NK) cells can kill a broad array of tumor cells in a non-major histocompatibility complex(MHC)-restricted manner. Adoptive transfer of NK may prolong the survival of patients with cancer. This study evaluates the efficacy and safety of NK cell-based immunotherapy for small-cell lung cancer (SCLC) after first-line chemotherapy. Half of the participants will receive autologous adoptive transfer of NK cells after the response from first-line chemotherapy, while the other half will be followed up in routine clinal practice.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Small Cell Lung Cancer | Lung Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| NK cells | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- autologous natural killer cells
- description
- Infusion of 1-2×10\^9 NK cells every 14 days in the absence of progression or unacceptable toxicity until the 6 courses of treatment.
- interventionNames
- Biological: NK cells
- type
- NO_INTERVENTION
- label
- routine follow-up
- description
- According to present guideline, no special treatment is advised for patients with SCLC after first-line therapy.They will be followed-up regularly.
Primary outcomes (1)
- measure
- Progression-free survival(PFS)
- timeFrame
- 20 months
- description
- Progression-free survival is defined as the time from randomization to first observation of progression or date of death (from any cause). Progression will be evaluated according to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1. Patients who do not progress or not die will be censored on the date of their last tumor assessment, i.e. on the last date that we really know that the patient is considered as "progression-free".
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically or cytologically confirmed small cell lung cancer. * Having completed first-line therapy in the presence of stable disease (SD), partial remission (PR) or complete remission (CR) status. * Age ≥18 years. * Karnofsky Performance Status (KPS) ≥80. * Important organs:cardiac ejection fraction \>50%; Pulse Oxygen Saturation(SpO2) \>90%; creatinine (Cr) ≤ 2.5 times the normal range; alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤3 times the normal range, total bilirubin (TBIL)≤2.0mg/dl (34.2umol/L);Hgb≥60g/L. * Without contraindication of apheresis and cell isolation. * Patients and their families having the willingness to participate in clinical trial with signed written informed consent. Exclusion Criteria: * Patient having an active rheumatic immunologic disease. * Uncontrolled bacterial, fungal or viral infection. * human immunodeficiency virus(HIV), hepatitis B virus infection(HBV), hepatitis C virus(HCV) infection. * History of organ transplantation and hemopoietic stem cell transplantation. * Pregnant or lactating women. * Patients using immunosuppressive agents within the first 3 months of the study or received glucocorticoid systemic therapy within a week prior to entry into the study. * Patients receiving other immunotherapy after diagnosis.
References
Publications (0)
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