CClinicalTrials.gg
Status unknownNCT02734524Updated Jan 23, 2018

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

A Phase 2 interventional study of NK cells and Taxol in Non-small Cell Lung Cancer, sponsored by Southwest Hospital, China. Status unknown at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2018-01-23.

Sponsored by Southwest Hospital, China · Phase 2, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jan 2018), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 2
Study type
Interventional
Enrollment
104
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Non-small Cell Lung Cancer

Keywords

  • Natural killer cells
  • NSCLC
  • NCT
  • Combined therapy
03

In context

Lung Neoplasms

7,243 studies on the registry are indexed under Lung Neoplasms; 1,557 are open to participants now.

This study's planned enrollment of 104 is above the median of 60 across 5,295 interventional studies indexed under Lung Neoplasms.

Browse Lung Neoplasms studies →

Lead sponsor

Southwest Hospital, China is the lead sponsor of 85 studies on the registry; 16 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
104 participants (estimated)

Study arms

  • 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 · Drug: Taxol · Drug: Carboplatin

  • Active comparator
    chemotherapy

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

    Drug: Taxol · Drug: Carboplatin

Interventions

  • BiologicalNK cells

    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

  • DrugTaxol

    135-175mg/m2,q28d\*4

    Also known as: TAX

  • DrugCarboplatin

    AUC=5,q28d\*4

    Also known as: Cis-platinum

06

What researchers measure

Primary outcomes

  1. Number of participants responding to treatment

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

    Time frame: 4 months

Secondary outcomes

  1. Progress free survival(PFS) time

    Time frame: 2 years

  2. Overall survival time

    Time frame: 2 years

07

Study locations

1 of 1 sites recruiting
  • Southwest Hospital of Third Millitary Medical University
    Chongqing, Chongqing 400000, China
    • Cheng Qian, PhD · Contact · cqian3184@163.com · 008615086883400
    • Zhi Yang, PhD · Contact · 008613206140093
    • Cheng Qian, PhD · Principal investigator
    Recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 23, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02734524
Lead sponsor
Southwest Hospital, China
Responsible party
Shiqi Li (Researcher of Biotherapy Center, Southwest Hospital, China) — Principal investigator
First posted
Apr 12, 2016
Start date
Mar 2016
Primary completion
Mar 2018 (estimated)
Completion
Mar 2019 (estimated)
Last update
Jan 23, 2018

Study contacts

Cheng Qian, MD, PhD
Contact
cqian3184@163.com
0086-023-68765461
Zhi Yang, PhD
Contact
Lystch@qq.com
0086-13206140093
Cheng Qian, MD, PhD
study chair · Biotherapy Center of Southwest Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jan 2018. You cannot join it, but the record below documents what was studied.

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