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TerminatedNCT01871480Updated Dec 30, 2013

CIK Cell Transfusion Plus Gefitinib As Second Or Third-Line Treatment for Advanced Adenocarcinoma Non-Small Cell Lung Cancer

A Phase 2 interventional study of Group A:cytokine-induced killer cell +gefitinib and Group B:Gefitinib in Non-Small Cell Lung Cancer, sponsored by Kunming Medical University. Terminated at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2013-12-30.

Sponsored by Kunming Medical University · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study summary

Lung cancer is the most common cancer worldwide, non-small cell lung cancer (NSCLC) comprises about 85% of all lung cancer cases, which is the leading cause of cancer mortality, and adenocarcinoma is the most prevalent subtype. Gefitinib showed lower efficiency of treatment as second or third-line in patients with advanced adenocarcinoma NSCLC. It is necessary to further improve the efficiency of treatment in patients with advanced NSCLC. Immunotherapy with cytokine-induced killer cells (CIK) may improve tumor control and survival, as well as a better quality of life. This study is to evaluate the efficacy of Autologous CIK Transfusion plus Gefitinib for advanced, recurrence, metastatic adenocarcinoma NSCLC.

Read the detailed description

Lung cancer is the most common cancer worldwide, non-small cell lung cancer (NSCLC) comprises about 85% of all lung cancer cases, which is the leading cause of cancer mortality, and adenocarcinoma is the most prevalent subtype. The epidermal growth factor receptor (EGFR) adenosine triphosphate-competitive tyrosine kinase inhibitors gefitinib showed success in the treatment of advanced adenocarcinoma NSCLC following the failure of front-line chemotherapy. However, the efficiency of treatment as second or third-line in patients with advanced adenocarcinoma NSCLC is also low. It is necessary to further improve the efficiency of treatment in patients with advanced NSCLC. Biological treatment is an effective adjuvant treatment in comprehensive cancer treatment. Immunotherapy with cytokine-induced killer cells (CIK) characterized as fast amplification, strong anti-cancer activity and broad anti-tumor spectrum, this effect may improve tumor control and survival, as well as a better quality of life. This study is to evaluate the efficacy of Autologous CIK Transfusion plus Gefitinib for advanced, recurrence, metastatic adenocarcinoma NSCLC.

02

Conditions studied

  • Non-Small Cell Lung Cancer

Keywords

  • NSCLC
  • CIK
  • Gefitinib
  • Adenocarcinoma
03

In context

Lung Neoplasms

7,243 studies on the registry are indexed under Lung Neoplasms; 1,558 are open to participants now.

This study's planned enrollment of 50 is below the median of 60 across 5,296 interventional studies indexed under Lung Neoplasms.

Browse Lung Neoplasms studies →

Lead sponsor

Kunming Medical University is the lead sponsor of 11 studies on the registry; 1 is open to participants now.

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

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Age between 18 to 80 years
  • Histologically or cytologically proven advanced adenocarcinoma non-small-cell lung cancer
  • Life expectancy more than 12 weeks
  • Not received EGFR agent or cell immunotherapy before entry into this study
  • World Health Organization- Eastern Cooperative Oncology Group Performance Status 0-3
  • Gefitinib as the second or third line therapy
  • More than 4 weeks must have completion of the last dose of chemotherapy, radiation therapy, investigational therapy and patients must adequately recover from these effects
  • Disease measurable
  • Patients must have adequate organ and marrow functions as defined below: white blood cells: more than 3.0×109/L, Neutrophils: more than 1.5×109/L, Platelets: more than 75×109/L, Hemoglobin more than 80g/L, Serum total bilirubin less than 1.25 folds of the upper normal limit (ULN), Serum glutamic-oxal (o) acetic transaminase: less than 2.5×ULN, Serum glutamate pyruvate transaminase: less than 2.5×ULN, Serum creatinine: less than 1.25×ULN, Blood urea nitrogen: less than 2×ULN.
  • Pregnancy test: the test of women of child-bearing period must be negative before entry into this study
  • Subject must have good compliance and voluntarily to sign a written informed consent

Exclusion criteria

Exclusion Criteria:

  • Acute infection
  • Uncontrolled concurrent illness: hypersensitiveness, asthma, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, serious heart valve disease
  • Psychiatric illness, pharmacological dependence, or other situation that would limit compliance with study requirements
  • History of other neoplasms
  • Coagulation disorder and bleeding tendency
  • Pertinacious hypertension(systolic blood pressure > 140 mmHg or diastolic blood pressure > 90 mmHg) after aggressive therapy
  • Brain metastasis with symptomatic
  • Severe liver dysfunction
  • Autoimmune disease (e.g. systemic lupus erythematosus, rheumatoid arthritis, thyroadenitis, et al )
  • Patients who diagnosed as virus hepatitis, syphilis or HIV, or other infectious diseases
  • Employment of corticosteroids or other immunodepressive hormone therapies
  • With main organs transplantation
  • Pregnant or lactating women
  • Known or suspected in patients with severe hypersensitivity to CIK or gefitinib or to any other component of gefitinib
  • Patients receiving any other investigational agents in 30 days or prepare to participate in other investigation in the clinical period
05

Study design

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

Study arms

  • Experimental
    Group A

    Gefitinib combination with CIK cell immunotherapy

    Drug: Group A:cytokine-induced killer cell +gefitinib

  • Active comparator
    Group B

    Gefitinib alone

    Drug: Group B:Gefitinib

Interventions

  • DrugGroup A:cytokine-induced killer cell +gefitinib

    CIK cells: intravenous infusions; D14-16; one cycle every month,at least 6 cycles;Gefitinib treated with 250mg for daily oral administration in the absence of disease progression or unacceptable toxicity.

  • DrugGroup B:Gefitinib

    Gefitinib treated with 250mg for daily oral administration in the absence of disease progression or unacceptable toxicity

06

What researchers measure

Primary outcomes

  1. Progression-free survival

    Time frame: up to 2 years

Secondary outcomes

  1. Overall survival

    Time frame: up to 3 years

Other outcomes

  1. Quality-of-life

    Time frame: Three years

07

Study locations

1 site
  • Department of Cancer Biotherapy Center, The Third Affiliated Hospital of Kunming Medicine University
    Kunming, Yunnan 650118, China
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 30, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01871480
Lead sponsor
Kunming Medical University
Responsible party
Song Xin (Chief of the Department of Cancer Biotherapy Center, The Third Affiliated Hospital of Kunming Medicine University, Kunming Medical University) — Principal investigator
First posted
Jun 6, 2013
Start date
May 2013
Primary completion
Nov 2015 (estimated)
Completion
May 2016 (estimated)
Last update
Dec 30, 2013

Study contacts

Xin Song, MD
study chair · The Third Affiliated Hospital of Kunming Medicine University

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Dec 2013. You cannot join it, but the record below documents what was studied.

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