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

A

Army Medical University

Status and phase

Unknown
Phase 2

Conditions

Non-small Cell Lung Cancer

Treatments

Drug: Carboplatin
Biological: NK cells
Drug: Taxol

Study type

Interventional

Funder types

Other

Identifiers

NCT02734524
TMMU-BTC-004

Details and patient eligibility

About

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.

Full 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.

Enrollment

104 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No 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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

104 participants in 2 patient groups

NK infusion+chemotherapy
Experimental group
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.
Treatment:
Drug: Taxol
Biological: NK cells
Drug: Carboplatin
chemotherapy
Active Comparator group
Description:
Receive the same taxol and carboplatin in experimental arm without NK cell infusion.
Treatment:
Drug: Taxol
Drug: Carboplatin

Trial contacts and locations

1

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Central trial contact

Cheng Qian, MD, PhD; Zhi Yang, PhD

Data sourced from clinicaltrials.gov

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