Non-small Cell Lung CancerPhase 1NCT03282435
Treatment of Non-small Cell Lung Cancer With Cytokine-induced Killer (CIK) Cells Blocked by PD-1 Antibody
A Phase 1 study testing CIK cells with PD-1 blocking, standard lung cancer treament and CIK cells without PD-1 blocking in people with Non-small Cell Lung Cancer, run by Dalian University.
Trial summary
to evaluate the prognosis of non-small cell lung carcinoma patients under CIK cellular treatment with PD-1 blocking on top of the standard therapy Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Non-small Cell Lung Cancer
- What is being tested?
- CIK cells with PD-1 blocking, standard lung cancer treament and CIK cells without PD-1 blocking
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Jan 2018to Jan 2023
- Phase
- Phase 1
- 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 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- non-small cell lung cancer;
- more than 50% tumor tissues positive with PD-L1;
- EGFR and ALK wild type
- no other tumors
Who cannot join
- with systematic diseases shortening survival
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Treatment of Non-small Cell Lung Cancer With CIK Cells Blocked by PD-1 Antibody
to evaluate the prognosis of non-small cell lung carcinoma patients under CIK cellular treatment with PD-1 blocking on top of the standard therapy
- Conditions
- Non-small Cell Lung Cancer
- Being tested
- CIK cells with PD-1 blocking, standard lung cancer treament, CIK cells without PD-1 blocking
- 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.
CIK cells with PD-1 blockingBiological
CIK cellular therapy with PD-1 blocking
standard lung cancer treamentOther
standard non-small cell lung cancer treatment: surgery, chemotherapy
CIK cells without PD-1 blockingBiological
CIK cellular therapy without PD-1 blocking
| Study group | Role | What they receive |
|---|---|---|
| CIK cells with PD-1 blocking | Experimental | CIK cellular therapy with PD-1 blocking combined with standard lung cancer treatment Receives: Biological: CIK cells with PD-1 blocking; Other: standard lung cancer treament |
| CIK cells without PD-1 blocking | Active comparator | CIK cellular therapy without PD-1 blocking combined with the same standard lung cancer treatment as the experimental group patients receive Receives: Other: standard lung cancer treament; Biological: CIK cells without PD-1 blocking |
What is being measured
The primary outcome is the main question the study is designed to answer.
progression-free survival
Measured: 5 years
metastasis-free survival
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2017
- Study startJan 2018 (estimated)
- Primary completionJan 2023 (estimated)
- Study completionJan 2023 (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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dalian University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- xiaolin Yuan, Principal investigator, Affiliated Zhongshan Hospital of Dalian University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03282435
- Sponsor's protocol ID
- zsyy_zxsys2018-01
- Status last verified
- Sep 2017
- First submitted
- 12 Sep 2017
- Last updated
- 14 Sep 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: age, gender, tumor staging
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Non-small Cell Lung Cancer With CIK Cells Blocked by PD-1 Antibody
- ClinicalTrials.gov ID
- NCT03282435
- Acronym / sponsor ID
- zsyy_zxsys2018-01
- Conditions
- Non-small Cell Lung Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Dalian UniversityUniversity, hospital or other
- Study start
- Jan 2018 (estimated)
- Primary completion
- Jan 2023 (estimated)
- Study completion
- Jan 2023 (estimated)
- First posted
- 14 Sep 2017 (actual)
- 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.
to evaluate the prognosis of non-small cell lung carcinoma patients under CIK cellular treatment with PD-1 blocking on top of the standard therapy
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CIK cells with PD-1 blocking | Experimental | Biological: CIK cells with PD-1 blocking, Other: standard lung cancer treamentCIK cellular therapy with PD-1 blocking combined with standard lung cancer treatment |
| CIK cells without PD-1 blocking | Active comparator | Other: standard lung cancer treament, Biological: CIK cells without PD-1 blockingCIK cellular therapy without PD-1 blocking combined with the same standard lung cancer treatment as the experimental group patients receive |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- non-small cell lung cancer;
- more than 50% tumor tissues positive with PD-L1;
- EGFR and ALK wild type
- no other tumors
Key exclusion criteria (1 listed)
- with systematic diseases shortening survival
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 |
|---|---|---|
| CIK cells with PD-1 blockingCIK cellular therapy with PD-1 blocking | Biological | CIK cells with PD-1 blocking |
| standard lung cancer treamentstandard non-small cell lung cancer treatment: surgery, chemotherapy | Other | CIK cells with PD-1 blocking, CIK cells without PD-1 blocking |
| CIK cells without PD-1 blockingCIK cellular therapy without PD-1 blocking | Biological | CIK cells without PD-1 blocking |
Primary outcome
progression-free survival
Time frame: 5 years
metastasis-free survival
Time frame: 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2017.
- Individual participant dataSharing planned: Yes. age, gender, tumor staging
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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.
xiaolin Yuan principal investigator
Affiliated Zhongshan Hospital of Dalian University
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CIK cells with PD-1 blocking, standard lung cancer treament and CIK cells without PD-1 blocking in people with Non-small Cell Lung Cancer, run by Dalian University.
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 4 inclusion and 1 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 14 Sep 2017. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 haoren wang (86-041162893507, haoren_wang@yahoo.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: 5 years). The study lists 2 primary outcomes in all. 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 14 Sep 2017.