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

NCT ID: NCT02734524

Last Updated: 2018-01-23

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 104 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-03-31
• Study Completion Date: 2019-03-31

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.

Conditions

Non-small Cell Lung Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

NK cells

Intervention Type: BIOLOGICAL

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

Taxol

Intervention Type: DRUG

135-175mg/m2,q28d\*4

Carboplatin

Intervention Type: DRUG

AUC=5,q28d\*4

chemotherapy

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

Group Type: ACTIVE_COMPARATOR

Taxol

Intervention Type: DRUG

135-175mg/m2,q28d\*4

Carboplatin

Intervention Type: DRUG

AUC=5,q28d\*4

Interventions

NK cells

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

Intervention Type: BIOLOGICAL

Taxol

135-175mg/m2,q28d\*4

Intervention Type: DRUG

Carboplatin

AUC=5,q28d\*4

Intervention Type: DRUG

Other Intervention Names

natural killer cell infusion; TAX; Cis-platinum

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Southwest Hospital, China

OTHER

Sponsor Role: lead

Responsible Party

Shiqi Li

Researcher of Biotherapy Center

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Cheng Qian, MD, PhD

Role: STUDY_CHAIR

Biotherapy Center of Southwest Hospital

Locations

Southwest Hospital of Third Millitary Medical University

Chongqing, Chongqing Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Cheng Qian, MD, PhD

Role: CONTACT

cqian3184@163.com

0086-023-68765461

Zhi Yang, PhD

Role: CONTACT

Lystch@qq.com

0086-13206140093

Facility Contacts

Cheng Qian, PhD

Role: primary

cqian3184@163.com

008615086883400

Zhi Yang, PhD

Role: backup

008613206140093

Other Identifiers

TMMU-BTC-004

Identifier Type: -

Identifier Source: org_study_id