Clinical study of a combined use of EGFR-TKI and autologous lymphocyte-activated killer cells (LAK) therapy for advanced non-small cell lung cancer.

UMIN ID: UMIN000001966

Registered date:13/05/2009

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: non-small cell lung cancer
• Date of first enrollment: 2009/05/01
• Target sample size: 10
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): Autologous Lymphocyte-Activated Killer cells (LAK) are injected on day0,day14,day28,day42,day56,day70. EGFR-TKI regulated dosage,regimen/day,oral daily.

Outcome(s)

• Primary Outcome: Antitumor effect
• Secondary Outcome: Progression-free survival Overall survival Survival rate Improvement of tumor-related markers QOL(FACT-BRM) Safety

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude criteria: Patients who have: -Previous history of hypersensitivity to EGFR-TKI -Uncontrolled infections -Active autoimmune diseases -Serious cardiac disease -Continuous systemic administration of steroids. -Other cancer who are pregnant, to be pregnant, or nursing mothers, and whom principle investigator or co-investigator judged to be inappropriate to participate in this study.

Related Information

• Primary Sponsor: Juntendo University, School of Medicine
• Secondary Sponsor: Seta Clinic Group
• Source(s) of Monetary Support: Medinet Co.,Ltd