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

Primary Purpose

Non-small Cell Lung Cancer

Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
NK cells
Taxol
Carboplatin
Sponsored by
Southwest Hospital, China
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-small Cell Lung Cancer focused on measuring Natural killer cells, NSCLC, NCT, Combined therapy

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. 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.
  2. According to Response Evaluation Criteria in Solid Tumors(RECIST), at least one measurable or evaluable nidus can be detected by chest CT.
  3. ECOG score 0-1.
  4. Gender is not limited, age from 18 years to 75 years.
  5. Patients are expected to survive for more than 3 months by their physicians at the time of enrollment.
  6. Mental state is evaluated as normal.
  7. Adequate cardiac function(LVEF≥40%, tested within one month) without heart diseases.
  8. 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.
  9. No other serious illnesses(e.g.,autoimmune disease, immunodeficiency, ect.).
  10. Ability to give informed consent.
  11. No other malignancies diagnosed.
  12. Patients volunteer to participate in the research.

Exclusion Criteria:

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

  1. Frequent infection history and recent infection is uncontrolled.
  2. Patients with concomitant genetic syndrome: patients with Down syndrome, Fanconi anemia, Kostmann syndrome, Shwachman syndrome or any other known bone marrow failure syndrome
  3. 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.
  4. Pregnancy and nursing females.
  5. HIV infection.
  6. Active hepatitis B or active hepatitis C.
  7. 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.
  8. Class III/IV cardiovascular disability according to the New York Heart Association Classification.
  9. Patients with a known history or prior diagnosis of other serious immunologic, malignant or inflammatory disease.
  10. Other situations we think not eligible for participation in the research.

Sites / Locations

  • Southwest Hospital of Third Millitary Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

NK infusion+chemotherapy

chemotherapy

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Progress free survival(PFS) time
Overall survival time

Full Information

First Posted
November 8, 2015
Last Updated
January 20, 2018
Sponsor
Southwest Hospital, China
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1. Study Identification

Unique Protocol Identification Number
NCT02734524
Brief Title
A Clinical Research of NK Cell Infusion Combined With Chemotherapy in the Treatment of Non-small Cell Lung Cancer
Official Title
A Clinical Research of NK Cell Infusion Combined With Chemotherapy in the Treatment of Non-small Cell Lung Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
January 2018
Overall Recruitment Status
Unknown status
Study Start Date
March 2016 (undefined)
Primary Completion Date
March 2018 (Anticipated)
Study Completion Date
March 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Southwest Hospital, China

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-small Cell Lung Cancer
Keywords
Natural killer cells, NSCLC, NCT, Combined therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
104 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
NK infusion+chemotherapy
Arm Type
Experimental
Arm Description
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.
Arm Title
chemotherapy
Arm Type
Active Comparator
Arm Description
Receive the same taxol and carboplatin in experimental arm without NK cell infusion.
Intervention Type
Biological
Intervention Name(s)
NK cells
Other Intervention Name(s)
natural killer cell infusion
Intervention Description
Natural killer cell infusion is an intervention between two arms. Dosage of infused cell >1×10^9,q28d*4
Intervention Type
Drug
Intervention Name(s)
Taxol
Other Intervention Name(s)
TAX
Intervention Description
135-175mg/m2,q28d*4
Intervention Type
Drug
Intervention Name(s)
Carboplatin
Other Intervention Name(s)
Cis-platinum
Intervention Description
AUC=5,q28d*4
Primary Outcome Measure Information:
Title
Number of participants responding to treatment
Description
Response evaluation of treatment with chest CT scan is assessed by RECIST 1.1
Time Frame
4 months
Secondary Outcome Measure Information:
Title
Progress free survival(PFS) time
Time Frame
2 years
Title
Overall survival time
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Cheng Qian, MD, PhD
Phone
0086-023-68765461
Email
cqian3184@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Zhi Yang, PhD
Phone
0086-13206140093
Email
Lystch@qq.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cheng Qian, MD, PhD
Organizational Affiliation
Biotherapy Center of Southwest Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Southwest Hospital of Third Millitary Medical University
City
Chongqing
State/Province
Chongqing
ZIP/Postal Code
400000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cheng Qian, PhD
Phone
008615086883400
Email
cqian3184@163.com
First Name & Middle Initial & Last Name & Degree
Zhi Yang, PhD
Phone
008613206140093
First Name & Middle Initial & Last Name & Degree
Cheng Qian, PhD

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

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