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Maintenance Immunotherapy With Autologous Cytokine-induced Killer Cells for Stage IIIb/IV Nonsquamous Non-small Cell Lung Cancer


Phase 2/Phase 3
18 Years
75 Years
Open (Enrolling)
Both
Non-small Cell Lung Cancer

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Trial Information

Maintenance Immunotherapy With Autologous Cytokine-induced Killer Cells for Stage IIIb/IV Nonsquamous Non-small Cell Lung Cancer


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression-free survival

Outcome Time Frame:

One year

Safety Issue:

No

Principal Investigator

Guosheng Feng, M.D

Investigator Role:

Principal Investigator

Investigator Affiliation:

People's Hospital of Guangxi

Authority:

China: Ethics Committee

Study ID:

CIKLC-201004

NCT ID:

NCT01481259

Start Date:

January 2010

Completion Date:

July 2013

Related Keywords:

  • Non-Small Cell Lung Cancer
  • Nonsquamous non-small cell lung cancer
  • Maintenance therapy
  • Immunotherapy
  • Autologous cytokine-induced killer cell
  • Pemetrexed
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

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