Clinical trial · Interventional
Maintenance Therapy With Autologous Cytokine-induced Killer Cells for Nonsquamous Non-small Cell Lung Cancer
Maintenance Immunotherapy With Autologous Cytokine-induced Killer Cells for Stage IIIb/IV Nonsquamous Non-small Cell Lung Cancer
- 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)
Maintenance therapy has been considered as an important component to prolong survival in patients with advanced Nonsquamous Non-small Cell Lung Cancer (NSCLC). Previous studies have confirmed that pemetrexed is one of the effective drugs in improving progression-free survival for stage IIIb-IV nonsquamous non-small cell lung cancer. With the periodic deliveries of pemetrexed, however,the functioning status and immune system may get worse, which subsequently has an negative impact on patient's quality-of-life. Immunotherapy with autologous cytokine-induced killer (CIK) cells can activate the antitumor defense mechanism through stimulating immune response and altering the interaction between tumor and its host. This effect may result in improved tumor control and survival, as well as a better quality of life. To test the hypothesis, a randomised controlled study was conducted to compare CIK cells with pemetrexed as maintenance therapy for stage IIIb-IV nonsquamous non-small cell lung cancer.
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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Autologous cytokine-induced killer cell | Biological | — | UNRESOLVED |
| Pemetrexed | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Immunotherapy
- description
- Subjects receive autologous cytokine-induced killer cell infusion every 21 days
- interventionNames
- Biological: Autologous cytokine-induced killer cell
- type
- ACTIVE_COMPARATOR
- label
- Pemetrexed
- description
- Subjects receive pemetrexed infusion at a dose of 500mg/m2 every 21 days
- interventionNames
- Other: Pemetrexed
Primary outcomes (1)
- measure
- Progression-free survival
- timeFrame
- One year
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically or cytologically proven nonsquamous non-small cell lung cancer * Stage IIIb-IV, according to AJCC 2010 Staging System * Disease measurable * Patients are currently receiving two-drug chemotherapy regimen containing a platinum-based drug as first-line therapy * No chemotherapy or radiotherapy prior to first-line therapy * Age between 18-75 * Performance status \<2 * No congestive heart failure, severe arrhythmia,and coronal atherosclerosis heart disease * No uncontrolled metabolic disease, infection, and neurological disorders * No other malignancies * Signed study-specific consent form prior to study entry Exclusion Criteria: * Patients are currently receiving radiotherapy or any chemotherapy regimen other than two-drug containing a platinum-based drug as first-line therapy * Pregnant or lactating women * Patient having hepatitis B virus infection, active tuberculosis, or other infectious diseases
References
Publications (0)
Data not yet available