CIK Cell Transfusion Plus Chemotherapy as Adjuvant Therapy for Stage IB-IIIA Non-Small Cell Lung Cancer (NSCLC)

Study Overview
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Brief Summary
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Non - small cell lung cancer ( NSCLC ) accounts for more than 80% of lung cancer. The main treatment for early stage patients is surgical resection, but about 30% -70% patients will relapse. Postoperative chemotherapy is the major systemic treatment for surgical resection NSCLC patients. However, data show only 5-10% improvement in overall survival with systemic adjuvant chemotherapy. It is necessary to further improve the survival time of patients with lung cancer. Biological treatment is becoming a new treatment modality for Cancer following with surgery, radiotherapy and chemotherapy, and has been confirmed as an effective adjuvant treatment in comprehensive cancer treatment. Cytokine induced killer cells ( CIK) characterized as fast amplification, strong anti-cancer activity and broad anti-tumor spectrum is most widely used and thought to be the first choice for the new generation of anti-tumor adoptive immunotherapy. This Phase II study is investigating the efficacy of Autologous Cytokine-Induced Killer Cell Transfusion plus Chemotherapy as adjuvant therapy for stage IB-IIIA NSCLC.

Official Title
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A Phase 2,Open-label Study of Autologous Cytokine-Induced Killer Cell Transfusion Plus Chemotherapy as Adjuvant Therapy for Stage IB-IIIA Non-Small Cell Lung Cancer

Conditions
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Non-small Cell Lung Cancer

Intervention / Treatment
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* Drug: Autologous CIK Transfusion plus Chemotherapy
* Drug: chemotherapy alone


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Stage IB-IIIA post-surgery NSCLC patients with histologically confirmed. with an Eastern CooperativeOncology Group performance status of 0 or 1, at least 18 years of age adequate bone marrow reserve and organ function including calculated creatinine clearance 45 mL/min based on the standard Cockcroft and Gault formula patients had fully recovered from its acute effects. Exclusion Criteria: HIV positive autoimmune disease immune deficiency disorder organ transplantation received high dose glucocorticoid or other immune depressant within 4 weeks active clinically serious infections (> grade 2 NCI-CTC version 3.0) life threatening medical condition

Ages Eligible for Study
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Minimum Age: 18 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: Group A<br>Autologous CIK Transfusion plus Chemotherapy | Drug: Autologous CIK Transfusion plus Chemotherapy<br>* vinorelbine 25-30mg/m2 d1, d8 q3w; DDP 75mg/m2 d1 q3w; pemetrexed 500mg/m2 d1 q3w; carboplatin AUC 5/6 q3w; CIK infusion D14 q3w<br>|
| Active Comparator: Group B<br>chemotherapy alone | Drug: chemotherapy alone<br>* vinorelbine 25-30mg/m2 d1, d8 q3w; DDP 75mg/m2 d1 q3w; pemetrexed 500mg/m2 d1 q3w; carboplatin AUC 5/6 q3w;<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the relapse rate |  | 30 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cytokine-Induced Killer Cell, NSCLC, adjuvant therapy