Clinical trial NCT02734524: 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
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Non-small Cell Lung Cancer
Keywords: Natural killer cells
NSCLC
NCT
Combined therapy
Lead sponsor: Southwest Hospital, China
Sponsor class: OTHER
First posted: 2016-04-12
Enrollment: 104
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Number of participants responding to treatment
timeFrame: 4 months
Secondary outcomes:
measure: Progress free survival(PFS) time
timeFrame: 2 years
measure: Overall survival time
timeFrame: 2 years
Other outcomes:
Locations:
city: Chongqing
country: China
facility: Southwest Hospital of Third Millitary Medical University
state: Chongqing
Study officials:
affiliation: Biotherapy Center of Southwest Hospital
name: Cheng Qian, MD, PhD
role: STUDY_CHAIR
References: