Maintenance Therapy With Autologous Cytokine-induced Killer Cells for Nonsquamous Non-small Cell Lung Cancer
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ClinicalTrials.gov Identifier: NCT01481259 |
Recruitment Status : Unknown
Verified July 2012 by Guosheng Feng, People's Hospital of Guangxi.
Recruitment status was: Recruiting
First Posted : November 29, 2011
Last Update Posted : July 3, 2012
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Non-small Cell Lung Cancer | Biological: Autologous cytokine-induced killer cell Other: Pemetrexed | Phase 2 Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 120 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Maintenance Immunotherapy With Autologous Cytokine-induced Killer Cells for Stage IIIb/IV Nonsquamous Non-small Cell Lung Cancer |
Study Start Date : | January 2010 |
Estimated Primary Completion Date : | January 2013 |
Estimated Study Completion Date : | July 2013 |

Arm | Intervention/treatment |
---|---|
Experimental: Immunotherapy
Subjects receive autologous cytokine-induced killer cell infusion every 21 days
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Biological: Autologous cytokine-induced killer cell
Subjects receive autologous cytokine-induced killer cell infusion every 21 days in the absence of disease progression or unacceptable toxicity. |
Active Comparator: Pemetrexed
Subjects receive pemetrexed infusion at a dose of 500mg/m2 every 21 days
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Other: Pemetrexed
Subjects receive pemetrexed infusion at a dose of 500mg/m2 every 21 days in the absence of disease progression or unacceptable toxicity. |
- Progression-free survival [ Time Frame: One year ]
- Overall survival [ Time Frame: Two years ]
- Toxicities [ Time Frame: Two years ]
- Quality-of-life [ Time Frame: Two years ]

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Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01481259
Contact: Heming Lu, M.D | 86-771-218-6503 | luhming3632@163.com |
China, Guangxi | |
Clinical Cancer Center, People's Hospital of Guangxi Zhuang Autonomous Region | Recruiting |
Nanning, Guangxi, China, 530021 |
Principal Investigator: | Guosheng Feng, M.D | People's Hospital of Guangxi | |
Study Chair: | Hui Lin, M.D | People's Hospital of Guangxi | |
Study Chair: | Yuan Liang, M.D | Guangxi Department of Public Health | |
Study Chair: | Heming Lu, M.D | People's Hospital of Guangxi |
Responsible Party: | Guosheng Feng, Professor, People's Hospital of Guangxi |
ClinicalTrials.gov Identifier: | NCT01481259 |
Other Study ID Numbers: |
CIKLC-201004 |
First Posted: | November 29, 2011 Key Record Dates |
Last Update Posted: | July 3, 2012 |
Last Verified: | July 2012 |
Nonsquamous non-small cell lung cancer Maintenance therapy Immunotherapy Autologous cytokine-induced killer cell Pemetrexed |
Lung Neoplasms Carcinoma, Non-Small-Cell Lung Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases Respiratory Tract Diseases |
Carcinoma, Bronchogenic Bronchial Neoplasms Pemetrexed Antineoplastic Agents Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Folic Acid Antagonists Nucleic Acid Synthesis Inhibitors |