Clinical trial NCT01481259: Maintenance Therapy With Autologous Cytokine-induced Killer Cells for Nonsquamous Non-small Cell Lung Cancer
Official title: Maintenance Immunotherapy With Autologous Cytokine-induced Killer Cells for Stage IIIb/IV Nonsquamous Non-small Cell Lung Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Non-small Cell Lung Cancer
Keywords: Nonsquamous non-small cell lung cancer
Maintenance therapy
Immunotherapy
Autologous cytokine-induced killer cell
Pemetrexed
Lead sponsor: People's Hospital of Guangxi Zhuang Autonomous Region
Sponsor class: OTHER
First posted: 2011-11-29
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Progression-free survival
timeFrame: One year
Secondary outcomes:
measure: Overall survival
timeFrame: Two years
measure: Toxicities
timeFrame: Two years
measure: Quality-of-life
timeFrame: Two years
Other outcomes:
Locations:
city: Nanning
country: China
facility: Clinical Cancer Center, People's Hospital of Guangxi Zhuang Autonomous Region
state: Guangxi
Study officials:
affiliation: People's Hospital of Guangxi Zhuang Autonomous Region
name: Guosheng Feng, M.D
role: PRINCIPAL_INVESTIGATOR
affiliation: People's Hospital of Guangxi Zhuang Autonomous Region
name: Hui Lin, M.D
role: STUDY_CHAIR
affiliation: Guangxi Department of Public Health
name: Yuan Liang, M.D
role: STUDY_CHAIR
affiliation: People's Hospital of Guangxi Zhuang Autonomous Region
name: Heming Lu, M.D
role: STUDY_CHAIR
References: