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

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.

Study Overview

• Status: Unknown
• Conditions: Non-small Cell Lung Cancer
• Intervention / Treatment: Biological: NK cells; Drug: Taxol; Drug: Carboplatin

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 Type: Interventional
• Enrollment (Anticipated): 104
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Chongqing
    • Chongqing, Chongqing, China, 400000
      • Recruiting
      • Southwest Hospital of Third Millitary Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants responding to treatment	Response evaluation of treatment with chest CT scan is assessed by RECIST 1.1	4 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Overall survival time	2 years
Progress free survival(PFS) time	2 years

Collaborators and Investigators

• Sponsor: Southwest Hospital, China

Study record dates

Study Major Dates

• Study Start: March 1, 2016
• Primary Completion (Anticipated): March 1, 2018
• Study Completion (Anticipated): March 1, 2019

Study Registration Dates

• First Submitted: November 8, 2015
• First Submitted That Met QC Criteria: April 5, 2016
• First Posted (Estimate): April 12, 2016

Study Record Updates

• Last Update Posted (Actual): January 23, 2018
• Last Update Submitted That Met QC Criteria: January 20, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Keywords: NSCLC; Combined therapy; Natural killer cells; NCT
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Antineoplastic Agents; Carboplatin
• Other Study ID Numbers: TMMU-BTC-004

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED