Combination of Cetuximab and NK Immunotherapy for Recurrent Non-small Cell Lung Cancer

Study Overview
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Brief Summary
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The aim of this study is the safety and efficacy of Cetuximab plus natural killer(NK) immunotherapy to recurrent non-small cell lung cancer with EGFR mutation.

Detailed Description
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By enrolling patients with lung cancer adapted to enrolled criteria, this study will document for the first time the safety and the short and long term efficacy of the combined therapy using Cetuximab and NK cells. The safety will be evaluated by statistics of adverse reactions. The efficacy will be evaluated according to local relief degree, progress free survival (PFS) and overall survival (OS).

Conditions
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Recurrent Non-small Cell Lung Cancer

Intervention / Treatment
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* Drug: Cetuximab
* Biological: NK immunotherapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All standard therapies have failed according to NCCN guidelines or the patient refuses standard therapies after cancer recurrence Body tumor 1-6, the maximum tumor length < 5 cm KPS ≥ 70, lifespan > 6 months Platelet count ≥ 80×109/L，white blood cell count ≥ 3×109/L, neutrophil count ≥ 2×109/L, hemoglobin ≥ 80 g/L Exclusion Criteria: Patients with cardiac pacemaker Patients with brain metastasis Patients with grade 3 hypertension or diabetic complication, severe cardiac and pulmonary dysfunction

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 70 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: Cetuximab and NK immunotherapy<br>In this group, the patients who have EGFR mutation of lung cancer will receive regular Cetuximab treatment accompanied with multiple NK immunotherapy. The check indexes are CT scan and blood tests (including tumor markers, lymphocyte subsets and circulating tumor cell). | Drug: Cetuximab<br>* 400 mg/m2 IV over 120 minutes on day 1 of cycle 1 only, and 250 mg/m2 IV over 60 minutes weekly on ALL subsequent administrations<br>* Other names: Erbitux, C225;Biological: NK immunotherapy<br>* For each procedure, 10 billion cells will be infused in 4 times<br>|
| Active Comparator: Cetuximab<br>In this group, the patients who have EGFR mutation of lung cancer will receive regular Cetuximab to decrease tumor burden. The check indexes are CT scan and blood tests (including tumor markers, lymphocyte subsets and circulating tumor cell). | Drug: Cetuximab<br>* 400 mg/m2 IV over 120 minutes on day 1 of cycle 1 only, and 250 mg/m2 IV over 60 minutes weekly on ALL subsequent administrations<br>* Other names: Erbitux, C225;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Relief degree evaluated by RECIST | It will be evaluated by the Response Evaluation Criteria in Solid Tumors (RECIST) | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progress free survival (PFS) |  | 1 year | 
| Overall survival (OS) |  | 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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recurrent lung cancer, EGFR mutation, Cetuximab, NK immunotherapy