Adenocarcinoma of LungPhase 2NCT02493582
The Study of Apatinib Plus CIK as the Third Line Therapy for Advanced Lung Adenocarcinoma Patients With Wild-Type EGFR
A Phase 2 study testing Cytokine-Induced Killer Cells and Apatinib in people with Adenocarcinoma of Lung, run by The First People's Hospital of Changzhou.
Trial summary
The purpose of this study is to evaluate the safety and efficacy of Apatinib combined with cytokine-induced killer cell (CIK) vs Apatinib alone as the third line therapy for advanced lung adenocarcinoma patients with wild-type EGFR Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Adenocarcinoma of Lung
- What is being tested?
- Cytokine-Induced Killer Cells and Apatinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- No sites listed yet
- Study dates
- Jul 2015to Jul 2033
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically or cytologically confirmed Lung adenocarcinoma
- Wld-type EGFR
- Stage IIIB/IV
- Failure to prior chemotherapy
- Life expectancy of more than 3 months
- Tissue sample desired for genomic study
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- Age ≥ 18 years
- Performance status (WHO) < 3
- Adequate bone marrow function (absolute neutrophil count>1000/mm^3, platelet count > 100000/mm^3, hemoglobin > 9gr/mm^3)
- Adequate liver (bilirubin < 1.5 times upper limit of normal and SGOT/SGPT < 2 times upper limit of normal) and renal function (creatinine < 2mg/dl)
- Presence of two-dimensional measurable disease. The measurable disease should not have been irradiated
- Informed consent
Who cannot join
- Lung squamous cell carcinoma or other types of Non-Small cell lung cancer
- Small cell lung cancer
- Have previously received TKIs
- Hemoglobin<8.0 g/dL,White blood cell <3 X 10^9/L;Platelet count <75 X 10^9/L; alanine aminotransferase, glutamic-oxalacetic transaminase, blood urine nitrogen and creatinine more than normal limits on 3.0 times
- Known or suspected allergy to the investigational agent or any agent given in association with this trial
- Pregnant or lactating patients
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- Known history of Human Immunodeficiency Virus (HIV), Hepatitis C Virus (HCV) or TreponemaPallidun (TP) infection
- Patients who are suffering from serious autoimmune disease
- Patients who had used long time or are using immunosuppressant
- Patients who had active infection
- Patients who are suffering from serious organ dysfunction
- Patients who are suffering from other cancer
- Other situations that the researchers considered unsuitable for this study.
- Other concurrent uncontrolled illness
About this study
Official title: The Randomized, Controlled Clinical Trial of Apatinib Plus CIK as the Third Line Therapy for Lung Adenocarcinoma Patients With Wild-Type EGFR
The purpose of this study is to evaluate the safety and efficacy of Apatinib combined with cytokine-induced killer cell (CIK) vs Apatinib alone as the third line therapy for advanced lung adenocarcinoma patients with wild-type EGFR
Read the detailed description
400 patients with stage IIIB \& IV lung adenocarcinoma who had received surgery and chemotherapy,will be randomly divided into group A（Apatinib plus CIK treatment ) or group B（Apatinib), and the randomize ratio will be 1:1. Patients in group A will receive 3 cycles of CIK treatment (every 1 year) and Apatinib (continuous).Patients in group B will receive only Apatinib (continuous) .
- Conditions
- Adenocarcinoma of Lung
- Being tested
- Cytokine-Induced Killer Cells, Apatinib
- Keywords
- CIK, Apatinib, Lung Adenocarcinoma
- Medical subject headings
- Adenocarcinoma of Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cytokine-Induced Killer CellsBiological
Also called CIK
CIKs are used with Apatinib to treat lung adenocarcinoma patients with wild-type EGFR
ApatinibDrug
Also called YN968D1
Advanced lung adenocarcinoma patients with wild-type EGFR take Apatinib 850mg qd by mouth.
| Study group | Role | What they receive |
|---|---|---|
| Apatinib alone | Other | Apatinib(YN968D1) ,850mg,p.o.,qd,continuous. Receives: Drug: Apatinib |
| Apatinib+CIK | Experimental | Apatinib(YN968D1) ,850mg,p.o.,qd,continuous. plus autologous cytokine-induced killer cells 3 cycles,every 1 year,continuous. Receives: Biological: Cytokine-Induced Killer Cells; Drug: Apatinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival (OS)
Measured: 3 months
Secondary outcomes (1)
Progression-Free-Survival (PFS)
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2015 (estimated)
- Study startJul 2015
- Primary completionJul 2030 (estimated)
- Study completionJul 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adenocarcinoma of LungStudies 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The First People's Hospital of Changzhou
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02493582
- Sponsor's protocol ID
- CAA
- Status last verified
- Feb 2016
- First submitted
- 7 Jul 2015
- Last updated
- 5 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Randomized, Controlled Clinical Trial of Apatinib Plus CIK as the Third Line Therapy for Lung Adenocarcinoma Patients With Wild-Type EGFR
- ClinicalTrials.gov ID
- NCT02493582
- Acronym / sponsor ID
- CAA
- Conditions
- Adenocarcinoma of Lung
- Keywords
- CIK, Apatinib, Lung Adenocarcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- The First People's Hospital of ChangzhouUniversity, hospital or other
- Study start
- Jul 2015
- Primary completion
- Jul 2030 (estimated)
- Study completion
- Jul 2033 (estimated)
- First posted
- 9 Jul 2015 (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.
The purpose of this study is to evaluate the safety and efficacy of Apatinib combined with cytokine-induced killer cell (CIK) vs Apatinib alone as the third line therapy for advanced lung adenocarcinoma patients with wild-type EGFR
Detailed description
400 patients with stage IIIB \& IV lung adenocarcinoma who had received surgery and chemotherapy,will be randomly divided into group A（Apatinib plus CIK treatment ) or group B（Apatinib), and the randomize ratio will be 1:1. Patients in group A will receive 3 cycles of CIK treatment (every 1 year) and Apatinib (continuous).Patients in group B will receive only Apatinib (continuous) .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Apatinib alone | Other | Drug: ApatinibApatinib(YN968D1) ,850mg,p.o.,qd,continuous. |
| Apatinib+CIK | Experimental | Biological: Cytokine-Induced Killer Cells, Drug: ApatinibApatinib(YN968D1) ,850mg,p.o.,qd,continuous. plus autologous cytokine-induced killer cells 3 cycles,every 1 year,continuous. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Histologically or cytologically confirmed Lung adenocarcinoma
- Wld-type EGFR
- Stage IIIB/IV
- Failure to prior chemotherapy
- Life expectancy of more than 3 months
Key exclusion criteria (14 listed)
- Lung squamous cell carcinoma or other types of Non-Small cell lung cancer
- Small cell lung cancer
- Have previously received TKIs
- Hemoglobin<8.0 g/dL,White blood cell <3 X 10^9/L;Platelet count <75 X 10^9/L; alanine aminotransferase, glutamic-oxalacetic transaminase, blood urine nitrogen and creatinine more than normal limits on 3.0 times
- Known or suspected allergy to the investigational agent or any agent given in association with this trial
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 |
|---|---|---|
| Cytokine-Induced Killer CellsAlso: CIKCIKs are used with Apatinib to treat lung adenocarcinoma patients with wild-type EGFR | Biological | Apatinib+CIK |
| ApatinibAlso: YN968D1Advanced lung adenocarcinoma patients with wild-type EGFR take Apatinib 850mg qd by mouth. | Drug | Apatinib alone, Apatinib+CIK |
Primary outcome
Overall Survival (OS)
Time frame: 3 months
1 secondary outcome
Progression-Free-Survival (PFS)
Time frame: 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2016.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Cytokine-Induced Killer Cells and Apatinib in people with Adenocarcinoma of Lung, run by The First People's Hospital of Changzhou.
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 12 inclusion and 14 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: under way, not looking for participants, as of the sponsor's last update on 5 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
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?
Overall Survival (OS) (time frame: 3 months). 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 5 Feb 2016.