Non-small Cell Lung CancerPhase 2/3NCT01481259
Maintenance Therapy With Autologous Cytokine-induced Killer Cells for Nonsquamous Non-small Cell Lung Cancer
A Phase 2/3 study testing Autologous cytokine-induced killer cell and Pemetrexed in people with Non-small Cell Lung Cancer, run by People's Hospital of Guangxi Zhuang Autonomous Region at 1 site in China.
Trial summary
Maintenance therapy has been considered as an important component to prolong survival in patients with advanced Nonsquamous Non-small Cell Lung Cancer (NSCLC). Previous studies have confirmed that pemetrexed is one of the effective drugs in improving progression-free survival for stage IIIb-IV nonsquamous non-small… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Non-small Cell Lung Cancer
- What is being tested?
- Autologous cytokine-induced killer cell and Pemetrexed
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- Jan 2010to Jul 2013
- Phase
- Phase 2/3
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically or cytologically proven nonsquamous non-small cell lung cancer
- Stage IIIb-IV, according to AJCC 2010 Staging System
- Disease measurable
- Patients are currently receiving two-drug chemotherapy regimen containing a platinum-based drug as first-line therapy
- No chemotherapy or radiotherapy prior to first-line therapy
- Age between 18-75
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- Performance status <2
- No congestive heart failure, severe arrhythmia,and coronal atherosclerosis heart disease
- No uncontrolled metabolic disease, infection, and neurological disorders
- No other malignancies
- Signed study-specific consent form prior to study entry
Who cannot join
- Patients are currently receiving radiotherapy or any chemotherapy regimen other than two-drug containing a platinum-based drug as first-line therapy
- Pregnant or lactating women
- Patient having hepatitis B virus infection, active tuberculosis, or other infectious diseases
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Clinical Cancer Center, People's Hospital of Guangxi Zhuang Autonomous Region
Nanning, Guangxi, 530021
About this study
Official title: Maintenance Immunotherapy With Autologous Cytokine-induced Killer Cells for Stage IIIb/IV Nonsquamous Non-small Cell Lung Cancer
Maintenance therapy has been considered as an important component to prolong survival in patients with advanced Nonsquamous Non-small Cell Lung Cancer (NSCLC). Previous studies have confirmed that pemetrexed is one of the effective drugs in improving progression-free survival for stage IIIb-IV nonsquamous non-small cell lung cancer. With the periodic deliveries of pemetrexed, however,the functioning status and immune system may get worse, which subsequently has an negative impact on patient's quality-of-life. Immunotherapy with autologous cytokine-induced killer (CIK) cells can activate the antitumor defense mechanism through stimulating immune response and altering the interaction between tumor and its host. This effect may result in improved tumor control and survival, as well as a better quality of life. To test the hypothesis, a randomised controlled study was conducted to compare CIK cells with pemetrexed as maintenance therapy for stage IIIb-IV nonsquamous non-small cell lung cancer.
- Conditions
- Non-small Cell Lung Cancer
- Being tested
- Autologous cytokine-induced killer cell, Pemetrexed
- Keywords
- Nonsquamous non-small cell lung cancer, Maintenance therapy, Immunotherapy, Autologous cytokine-induced killer cell, Pemetrexed
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autologous cytokine-induced killer cellBiological
Subjects receive autologous cytokine-induced killer cell infusion every 21 days in the absence of disease progression or unacceptable toxicity.
PemetrexedOther
Subjects receive pemetrexed infusion at a dose of 500mg/m2 every 21 days in the absence of disease progression or unacceptable toxicity.
| Study group | Role | What they receive |
|---|---|---|
| Immunotherapy | Experimental | Subjects receive autologous cytokine-induced killer cell infusion every 21 days Receives: Biological: Autologous cytokine-induced killer cell |
| Pemetrexed | Active comparator | Subjects receive pemetrexed infusion at a dose of 500mg/m2 every 21 days Receives: Other: Pemetrexed |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival
Measured: One year
Secondary outcomes (3)
Overall survival
Measured: Two years
Toxicities
Measured: Two years
Quality-of-life
Measured: Two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2011 (estimated)
- Study startJan 2010
- Primary completionJan 2013 (estimated)
- Study completionJul 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-small Cell Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- People's Hospital of Guangxi Zhuang Autonomous Region
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Guosheng Feng, People's Hospital of Guangxi Zhuang Autonomous Region
- Investigators
- Guosheng Feng, M.D, Principal investigator, People's Hospital of Guangxi Zhuang Autonomous RegionHui Lin, M.D, Study chair, People's Hospital of Guangxi Zhuang Autonomous RegionYuan Liang, M.D, Study chair, Guangxi Department of Public HealthHeming Lu, M.D, Study chair, People's Hospital of Guangxi Zhuang Autonomous Region
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01481259
- Sponsor's protocol ID
- CIKLC-201004
- Status last verified
- Jul 2012
- First submitted
- 16 Nov 2011
- Last updated
- 3 Jul 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Maintenance Immunotherapy With Autologous Cytokine-induced Killer Cells for Stage IIIb/IV Nonsquamous Non-small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT01481259
- Acronym / sponsor ID
- CIKLC-201004
- Conditions
- Non-small Cell Lung Cancer
- Keywords
- Nonsquamous non-small cell lung cancer, Maintenance therapy, Immunotherapy, Autologous cytokine-induced killer cell, Pemetrexed
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- People's Hospital of Guangxi Zhuang Autonomous RegionUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Jan 2013 (estimated)
- Study completion
- Jul 2013 (estimated)
- First posted
- 29 Nov 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Maintenance therapy has been considered as an important component to prolong survival in patients with advanced Nonsquamous Non-small Cell Lung Cancer (NSCLC). Previous studies have confirmed that pemetrexed is one of the effective drugs in improving progression-free survival for stage IIIb-IV nonsquamous non-small cell lung cancer. With the periodic deliveries of pemetrexed, however,the functioning status and immune system may get worse, which subsequently has an negative impact on patient's quality-of-life. Immunotherapy with autologous cytokine-induced killer (CIK) cells can activate the antitumor defense mechanism through stimulating immune response and altering the interaction between tumor and its host. This effect may result in improved tumor control and survival, as well as a better quality of life. To test the hypothesis, a randomised controlled study was conducted to compare CIK cells with pemetrexed as maintenance therapy for stage IIIb-IV nonsquamous non-small cell lung cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Immunotherapy | Experimental | Biological: Autologous cytokine-induced killer cellSubjects receive autologous cytokine-induced killer cell infusion every 21 days |
| Pemetrexed | Active comparator | Other: PemetrexedSubjects receive pemetrexed infusion at a dose of 500mg/m2 every 21 days |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Histologically or cytologically proven nonsquamous non-small cell lung cancer
- Stage IIIb-IV, according to AJCC 2010 Staging System
- Disease measurable
- Patients are currently receiving two-drug chemotherapy regimen containing a platinum-based drug as first-line therapy
- No chemotherapy or radiotherapy prior to first-line therapy
Key exclusion criteria (3 listed)
- Patients are currently receiving radiotherapy or any chemotherapy regimen other than two-drug containing a platinum-based drug as first-line therapy
- Pregnant or lactating women
- Patient having hepatitis B virus infection, active tuberculosis, or other infectious diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Autologous cytokine-induced killer cellSubjects receive autologous cytokine-induced killer cell infusion every 21 days in the absence of disease progression or unacceptable toxicity. | Biological | Immunotherapy |
| PemetrexedSubjects receive pemetrexed infusion at a dose of 500mg/m2 every 21 days in the absence of disease progression or unacceptable toxicity. | Other | Pemetrexed |
Primary outcome
Progression-free survival
Time frame: One year
3 secondary outcomes
Overall survival
Time frame: Two years
Toxicities
Time frame: Two years
Quality-of-life
Time frame: Two years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Guosheng Feng, M.D principal investigator
People's Hospital of Guangxi Zhuang Autonomous Region
Hui Lin, M.D study chair
People's Hospital of Guangxi Zhuang Autonomous Region
Yuan Liang, M.D study chair
Guangxi Department of Public Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Autologous cytokine-induced killer cell and Pemetrexed in people with Non-small Cell Lung Cancer, run by People's Hospital of Guangxi Zhuang Autonomous Region 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 3 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: status not confirmed, as of the sponsor's last update on 3 Jul 2012. 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 combined 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.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Heming Lu, M.D (86-771-218-6503, luhming3632@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival (time frame: One year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Jul 2012.