NCT01871480

CIK Cell Transfusion Plus Gefitinib As Second Or Third-Line Treatment for Advanced Adenocarcinoma Non-Small Cell Lung Cancer

An Open-label, Randomized, Controlled Study of Gefitinib Plus Autologous Cytokine-Induced Killer Cell Immunotherapy（CIK）Versus Gefitinib Alone As Second Or Third-Line Treatment in Patients With Advanced Adenocarcinoma Non-Small Cell Lung Cancer

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Kunming Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

Lung cancer is the most common cancer worldwide, non-small cell lung cancer (NSCLC) comprises about 85% of all lung cancer cases, which is the leading cause of cancer mortality, and adenocarcinoma is the most prevalent subtype. Gefitinib showed lower efficiency of treatment as second or third-line in patients with advanced adenocarcinoma NSCLC. It is necessary to further improve the efficiency of treatment in patients with advanced NSCLC. Immunotherapy with cytokine-induced killer cells (CIK) may improve tumor control and survival, as well as a better quality of life. This study is to evaluate the efficacy of Autologous CIK Transfusion plus Gefitinib for advanced, recurrence, metastatic adenocarcinoma NSCLC.

Detailed description

Lung cancer is the most common cancer worldwide, non-small cell lung cancer (NSCLC) comprises about 85% of all lung cancer cases, which is the leading cause of cancer mortality, and adenocarcinoma is the most prevalent subtype. The epidermal growth factor receptor (EGFR) adenosine triphosphate-competitive tyrosine kinase inhibitors gefitinib showed success in the treatment of advanced adenocarcinoma NSCLC following the failure of front-line chemotherapy. However, the efficiency of treatment as second or third-line in patients with advanced adenocarcinoma NSCLC is also low. It is necessary to further improve the efficiency of treatment in patients with advanced NSCLC. Biological treatment is an effective adjuvant treatment in comprehensive cancer treatment. Immunotherapy with cytokine-induced killer cells (CIK) characterized as fast amplification, strong anti-cancer activity and broad anti-tumor spectrum, this effect may improve tumor control and survival, as well as a better quality of life. This study is to evaluate the efficacy of Autologous CIK Transfusion plus Gefitinib for advanced, recurrence, metastatic adenocarcinoma NSCLC.

Conditions

• Non-Small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	Group A:cytokine-induced killer cell +gefitinib	CIK cells: intravenous infusions; D14-16; one cycle every month,at least 6 cycles;Gefitinib treated with 250mg for daily oral administration in the absence of disease progression or unacceptable toxicity.
DRUG	Group B:Gefitinib	Gefitinib treated with 250mg for daily oral administration in the absence of disease progression or unacceptable toxicity

Timeline

• Start date: 2013-05-01
• Primary completion: 2015-11-01
• Completion: 2016-05-01
• First posted: 2013-06-06
• Last updated: 2013-12-30

Locations

1 site across 1 country: China