A Clinical Research of NK Cell Infusion Combined With Chemotherapy in the Treatment of Non-small Cell Lung Cancer

Sponsor

Southwest Hospital, China (Other)

Overall Status

Unknown status

CT.gov ID

NCT02734524

Collaborator

(none)

104

Enrollment

Location

Arms

Duration (Months)

2.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The main purpose of this study is to explore if the combination of autologous NK cell infusion and chemotherapy can increase the therapeutic efficiency in the treatment of non-small cell lung cancer compared with chemotherapy alone.

Condition or Disease	Intervention/Treatment	Phase
Non-small Cell Lung Cancer	Biological: NK cells Drug: Taxol Drug: Carboplatin	Phase 2

Detailed Description

Natural killer cells play an important role in the anti-tumor process mediated by innate immunity. However, past researches showed dissatisfactory clinical outcome in clinicaltrials using autologous NK cell infusion alone. With the expectation that the combination of autologous NK cell infusion and chemotherapy may increase the therapeutic efficiency of chemotherapy alone in cancer treatment, the investigators design and conduct this randomized controlled trial in the treatment of non-small cell lung cancer.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

104 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A Clinical Research of NK Cell Infusion Combined With Chemotherapy in the Treatment of Non-small Cell Lung Cancer

Study Start Date :

Mar 1, 2016

Anticipated Primary Completion Date :

Mar 1, 2018

Anticipated Study Completion Date :

Mar 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: NK infusion+chemotherapy Treatment includes four cycles. For each cycle: Taxol and carboplatin will be given at the first week. Lymphodepletion will be conducted at the second week. Autologous NK cells will be infused at the third week. Each cycle includes four weeks.	Biological: NK cells Natural killer cell infusion is an intervention between two arms. Dosage of infused cell >1×10^9，q28d4 Other Names: natural killer cell infusion Drug: Taxol* 135-175mg/m2,q28d4 Other Names: TAX Drug: Carboplatin* AUC=5,q28d*4 Other Names: Cis-platinum
Active Comparator: chemotherapy Receive the same taxol and carboplatin in experimental arm without NK cell infusion.	Drug: Taxol 135-175mg/m2,q28d4 Other Names: TAX Drug: Carboplatin* AUC=5,q28d*4 Other Names: Cis-platinum

Arm

Intervention/Treatment

Experimental: NK infusion+chemotherapy

Treatment includes four cycles. For each cycle: Taxol and carboplatin will be given at the first week. Lymphodepletion will be conducted at the second week. Autologous NK cells will be infused at the third week. Each cycle includes four weeks.

Biological: NK cells

Natural killer cell infusion is an intervention between two arms. Dosage of infused cell >1×10^9，q28d*4

Other Names:

natural killer cell infusion

Drug: Taxol

135-175mg/m2,q28d*4

Other Names:

TAX

Drug: Carboplatin

AUC=5,q28d*4

Other Names:

Cis-platinum

Active Comparator: chemotherapy

Receive the same taxol and carboplatin in experimental arm without NK cell infusion.

Drug: Taxol

135-175mg/m2,q28d*4

Other Names:

TAX

Drug: Carboplatin

AUC=5,q28d*4

Other Names:

Cis-platinum

Outcome Measures

Primary Outcome Measures

Number of participants responding to treatment [4 months]
Response evaluation of treatment with chest CT scan is assessed by RECIST 1.1

Secondary Outcome Measures

Progress free survival(PFS) time [2 years]
Overall survival time [2 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Non-small cell lung cancer must be diagnosed by pathology and staged as ⅢB or Ⅳ with 2009-UICC TNM staging system and operation is excluded due to medical reasons or patient's will.
According to Response Evaluation Criteria in Solid Tumors(RECIST), at least one measurable or evaluable nidus can be detected by chest CT.
ECOG score 0-1.
Gender is not limited, age from 18 years to 75 years.
Patients are expected to survive for more than 3 months by their physicians at the time of enrollment.
Mental state is evaluated as normal.
Adequate cardiac function(LVEF≥40%, tested within one month) without heart diseases.
Hepatic and renal function were normal, biochemical criterion must meet the requests below: white blood cell count≥2.5×10^{9/L，platelet count≥100×10}9/L，hemoglobin≥90g/L, serum bilirubin≤2 upper limit of normal(ULN), AST and ALT≤2 ULN(AST, ALT≤5ULN under hepatic metastases), Bun≤2 ULN, serum creatinine≤2 ULN.
No other serious illnesses(e.g.,autoimmune disease, immunodeficiency, ect.).
Ability to give informed consent.
No other malignancies diagnosed.
Patients volunteer to participate in the research.

Exclusion Criteria:

Subjects meeting any of the following criteria are not eligible for participation in the study:

Frequent infection history and recent infection is uncontrolled.
Patients with concomitant genetic syndrome: patients with Down syndrome, Fanconi anemia, Kostmann syndrome, Shwachman syndrome or any other known bone marrow failure syndrome
Concurrent use of systemic steroids or chronic use of immunosuppressant medications. Recent or current use of inhaled steroids is not exclusionary. For additional details regarding use of steroid and immunosuppressant medications.
Pregnancy and nursing females.
HIV infection.
Active hepatitis B or active hepatitis C.
Participation in a prior investigational study within 4 weeks prior to enrollment or longer if required by local regulation. Participation in non-therapeutic research studies is allowed.
Class III/IV cardiovascular disability according to the New York Heart Association Classification.
Patients with a known history or prior diagnosis of other serious immunologic, malignant or inflammatory disease.
Other situations we think not eligible for participation in the research.