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

NCT02734524 | Unknown Phase 2

• 1 other identifier: TMMU-BTC-004
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 1

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.

Conditions

Non-small Cell Lung Cancer

Keywords

Natural killer cells; NSCLC; NCT; Combined therapy

Outcome Measures

Primary Outcomes (1)

• Number of participants responding to treatment

  Response evaluation of treatment with chest CT scan is assessed by RECIST 1.1

  4 months

Secondary Outcomes (2)

• Progress free survival(PFS) time

  2 years

• Overall survival time

  2 years

Study Arms (2)

NK infusion+chemotherapy

EXPERIMENTAL

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; Drug: Taxol; Drug: Carboplatin

chemotherapy

ACTIVE COMPARATOR

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

Drug: Taxol; Drug: Carboplatin

Interventions

NK cells BIOLOGICAL

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

Also known as: natural killer cell infusion

NK infusion+chemotherapy

Taxol DRUG

135-175mg/m2,q28d\*4

Also known as: TAX

NK infusion+chemotherapy; chemotherapy

Carboplatin DRUG

AUC=5,q28d\*4

Also known as: Cis-platinum

NK infusion+chemotherapy; chemotherapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• Southwest Hospital, China: lead

Study Sites (1)

Southwest Hospital of Third Millitary Medical University

Chongqing, Chongqing Municipality, 400000, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Paclitaxel; Taxes; Carboplatin; Cisplatin

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Economics; Health Care Economics and Organizations; Coordination Complexes; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Study Officials

• Cheng Qian, MD, PhD

  Biotherapy Center of Southwest Hospital

  STUDY CHAIR

Central Study Contacts

Cheng Qian, MD, PhD

CONTACT

0086-023-68765461; cqian3184@163.com

Zhi Yang, PhD

CONTACT

0086-13206140093; Lystch@qq.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Researcher of Biotherapy Center

Study Record Dates

• First Submitted: November 8, 2015
• First Posted: April 12, 2016
• Study Start: March 1, 2016
• Primary Completion: March 1, 2018
• Study Completion: March 1, 2019
• Last Updated: January 23, 2018

Record last verified: 2018-01

Locations

CN (1)