Clinical trial · Interventional
Combined Effect of Natural Killer Cell and Doublet Chemotherapy in Advanced NSCLC as the 1st Line Treatment
Combined Effect of Autologous Ex-vivo Expanded Activated NK Cell-lymphocytes (ANKL) and Doublet Chemotherapy in Patients With Advanced NSCLC as the 1st Line Treatment; Phase II
- 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)
The object of this study is to identify the combined effect of ANKL and doublet chemotherapy in advanced NSCLC. The investigators design the combination of ANKL and approved chemotherapy as the 3rd and 4th courses in the patients who get stable response after x2 induction as the first line chemotherapy. ANKL (2x10\*9) from peripheral blood 32ml is administered rapidly iv 12-36hr after each chemotherapeutic agents while peak effect of NK cell ligand modulation by chemotherapeutic agent is maintained. After 4th course, response evaluation is done by Response Evaluation Criteria in Solid Tumors (RECIST) and 40% or more partial response (PR, increased by 15% or more from historical control 25%) is the expected target and Simon's two stage design will be applied through the study (power 80%, a= 0.95, N1= 33, N= 68)
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 |
|---|---|---|---|
| Non-small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ANKL(Ex vivo-expanded NK cell enriched lymphocytes) | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- ANKL combined with chemotherapy
- description
- combination of ANKL and doublet chemotherapy as 3rd and 4th course in patients who get stable response after initial x2 courses
- interventionNames
- Biological: ANKL(Ex vivo-expanded NK cell enriched lymphocytes)
Primary outcomes (1)
- measure
- response rate
- timeFrame
- 1 month later after 4th course
- description
- confirmed response rate by CT scan
Secondary outcomes (1)
- measure
- progression free survival
- timeFrame
- 6 months
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * advanced NSCLC with measurable lesions, * age of 20 - 75 years, Eastern Cooperative Oncology Group (ECOG) * performance status (PS) of 0 to 2, and stable response after x2 induction chemotherapy as first line treatment. * No major organ dysfunction. Exclusion Criteria: * pregnant or lactating woman, * active hepatitis B or C, * AIDS or positivity for HIV, autoimmune diseases or treatment with immunosuppressive drugs, * prior radiotherapy to the target region
References
Publications (0)
Data not yet available