Maintenance Therapy With Autologous Cytokine-induced Killer Cells for Nonsquamous Non-small Cell Lung Cancer

Study Overview
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Brief Summary
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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.

Official Title
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Maintenance Immunotherapy With Autologous Cytokine-induced Killer Cells for Stage IIIb/IV Nonsquamous Non-small Cell Lung Cancer

Conditions
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Non-small Cell Lung Cancer

Intervention / Treatment
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* Biological: Autologous cytokine-induced killer cell
* Other: Pemetrexed


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Immunotherapy<br>Subjects receive autologous cytokine-induced killer cell infusion every 21 days | Biological: Autologous cytokine-induced killer cell<br>* Subjects receive autologous cytokine-induced killer cell infusion every 21 days in the absence of disease progression or unacceptable toxicity.<br>|
| Active Comparator: Pemetrexed<br>Subjects receive pemetrexed infusion at a dose of 500mg/m2 every 21 days | Other: Pemetrexed<br>* Subjects receive pemetrexed infusion at a dose of 500mg/m2 every 21 days in the absence of disease progression or unacceptable toxicity.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free survival |  | One year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival |  | Two years | 
| Toxicities |  | Two years | 
| Quality-of-life |  | Two years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Nonsquamous non-small cell lung cancer, Maintenance therapy, Immunotherapy, Autologous cytokine-induced killer cell, Pemetrexed