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Non-Small Cell Lung CancerPhase 2NCT01871480

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

A Phase 2 study testing Group A:cytokine-induced killer cell +gefitinib and Group B:Gefitinib in people with Non-Small Cell Lung Cancer, run by Kunming Medical University at 1 site in China.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Non-Small Cell Lung Cancer
What is being tested?
Group A:cytokine-induced killer cell +gefitinib and Group B:Gefitinib
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
1 siteChina
Study dates
May 2013to May 2016
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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
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  • 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

Trial locations and contacts

1 site in 1 country.

China1 site

  • Department of Cancer Biotherapy Center, The Third Affiliated Hospital of Kunming Medicine University

    Kunming, Yunnan, 650118

Other trials in China

About this study

Official title: An Open-label, Randomized, Controlled Study of Gefitinib Plus Autologous Cytokine-Induced Killer Cell Immunotherapy（CIK）Versus Gefitinib Alone As Second Or Third-Line Treatment in Patients With Advanced Adenocarcinoma Non-Small Cell Lung Cancer

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.

Being tested
Group A:cytokine-induced killer cell +gefitinib, Group B:Gefitinib
Keywords
NSCLC, CIK, Gefitinib, Adenocarcinoma
Medical subject headings
Carcinoma, Non-Small-Cell Lung, Adenocarcinoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Group A:cytokine-induced killer cell +gefitinibDrug

    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.

  • Group B:GefitinibDrug

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

Study groups in NCT01871480
Study groupRoleWhat they receive
Group AExperimentalGefitinib combination with CIK cell immunotherapy
Receives: Drug: Group A:cytokine-induced killer cell +gefitinib
Group BActive comparatorGefitinib alone
Receives: Drug: Group B:Gefitinib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression-free survival

    Measured: up to 2 years

Secondary outcomes (1)

  1. Overall survival

    Measured: up to 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Jun 2013 (estimated)
  2. Study startMay 2013
  3. Primary completionNov 2015 (estimated)
  4. Study completionMay 2016 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01871480
Sponsor's protocol ID
CIK plus gefitinib
Status last verified
Dec 2013
First submitted
4 Jun 2013
Last updated
30 Dec 2013
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Group A:cytokine-induced killer cell +gefitinib and Group B:Gefitinib in people with Non-Small Cell Lung Cancer, run by Kunming Medical University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 30 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early. Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-free survival (time frame: up to 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01871480.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Dec 2013; AzTrials last refreshed its copy on 31 Oct 2026.

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