Carcinoma, Non-Small-Cell LungPhase 1SKLB1608NCT02956551
Personalized DC Vaccine for Lung Cancer
A Phase 1 study testing DC vaccine in people with Carcinoma, Non-Small-Cell Lung, run by Sichuan University at 1 site in China.
Trial summary
The study is aimed to the test the efficacy and safety of neoantigen-primed dendritic cell (DC) cell vaccine therapy for refractory non-small cell lung cancer. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Carcinoma, Non-Small-Cell Lung
- What is being tested?
- DC vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 30 Nov 2016to 1 Jun 2020
- 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 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- pathologically confirmed non-small cell lung cancer
- failed in previous standard chemotherapy and targeted therapy
- anticipated life time > 3month
- Karnofsky performance status 0-1
- rehabilitate from previous therapy
- adequate organ functions
Who cannot join
- mixed histological types
- tumor emergency
- abnormal coagulation condition
- contagious diseases, such as hepatitis B virus, hepatitis C virus, human immunodefficiency virus, tuberculosis infection
- concomitant tumors
- immunological co-morbidities
Trial locations and contacts
1 site in 1 country.
Zhen-Yu Ding, Prof contact
China1 site, 1 recruiting
- Recruiting
China West Hospital
Chengdu, Sichuan, 610000
Zhen-Yu Ding, Prof, 00862885423571, dingzhenyu@scu.edu.cn
About this study
Official title: Neoantigen-primed DC Vaccine Therapy for Refractory Non-small Cell Lung Cancer
The study is aimed to the test the efficacy and safety of neoantigen-primed dendritic cell (DC) cell vaccine therapy for refractory non-small cell lung cancer.
Read the detailed description
Patients with pathological confirmed non-small cell lung cancer with no standard treatment are enrolled. The patients fails in previous at least 2 lines of chemotherapy and 1 line of targeted therapy where applicable. This is a prospective exploratory trial. Patients' rebiopsy tumor tissues are subsequent to whole exosome sequencing and possible neoantigens are identified. DC is in vitro primed with synthesized peptides. Both adverse events and responses are recorded.
- Conditions
- Carcinoma, Non-Small-Cell Lung
- Being tested
- DC vaccine
- Keywords
- advanced non-small cell lung cancer, cell based therapy, safety, clinical efficacy
- 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.
DC vaccineBiological
subcutaneous administration
| Study group | Role | What they receive |
|---|---|---|
| cell_therapy | Experimental | tumor neoantigen primed DC vaccines are administrated, 2-week interval, totally 5 times Receives: Biological: DC vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Measured: 3 months after the last administration of cells
Secondary outcomes (1)
objective response rate
Number of participants with objective responses as assayed by RECIST 1.1
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2016 (estimated)
- Study start30 Nov 2016
- Primary completion31 Dec 2019 (estimated)
- Study completion1 Jun 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carcinoma, Non-Small-Cell LungStudies of the same condition, open and under way.
- More trials run by Sichuan UniversityThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sichuan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhen-Yu Ding, Sichuan University
- Investigators
- Zhen-Yu Ding, Prof, Principal investigator, Sichuan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02956551
- Sponsor's protocol ID
- SKLB1608
- Acronym
- SKLB1608
- Status last verified
- May 2018
- First submitted
- 1 Nov 2016
- Last updated
- 31 May 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neoantigen-primed DC Vaccine Therapy for Refractory Non-small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT02956551
- Acronym / sponsor ID
- SKLB1608 / SKLB1608
- Conditions
- Carcinoma, Non-Small-Cell Lung
- Keywords
- advanced non-small cell lung cancer, cell based therapy, safety, clinical efficacy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Sichuan UniversityUniversity, hospital or other
- Study start
- 30 Nov 2016 (actual)
- Primary completion
- 31 Dec 2019 (estimated)
- Study completion
- 1 Jun 2020 (estimated)
- First posted
- 7 Nov 2016 (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 study is aimed to the test the efficacy and safety of neoantigen-primed dendritic cell (DC) cell vaccine therapy for refractory non-small cell lung cancer.
Detailed description
Patients with pathological confirmed non-small cell lung cancer with no standard treatment are enrolled. The patients fails in previous at least 2 lines of chemotherapy and 1 line of targeted therapy where applicable. This is a prospective exploratory trial. Patients' rebiopsy tumor tissues are subsequent to whole exosome sequencing and possible neoantigens are identified. DC is in vitro primed with synthesized peptides. Both adverse events and responses are recorded.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| cell_therapy | Experimental | Biological: DC vaccinetumor neoantigen primed DC vaccines are administrated, 2-week interval, totally 5 times |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- pathologically confirmed non-small cell lung cancer
- failed in previous standard chemotherapy and targeted therapy
- anticipated life time > 3month
- Karnofsky performance status 0-1
- rehabilitate from previous therapy
Key exclusion criteria (6 listed)
- mixed histological types
- tumor emergency
- abnormal coagulation condition
- contagious diseases, such as hepatitis B virus, hepatitis C virus, human immunodefficiency virus, tuberculosis infection
- concomitant tumors
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 |
|---|---|---|
| DC vaccinesubcutaneous administration | Biological | cell_therapy |
Primary outcome
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time frame: 3 months after the last administration of cells
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
1 secondary outcome
objective response rate
Time frame: through study completion, an average of 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2018.
- Individual participant dataSharing planned: Undecided
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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.
Zhen-Yu Ding, Prof contact
Zhen-Yu Ding, Prof principal investigator
Sichuan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing DC vaccine in people with Carcinoma, Non-Small-Cell Lung, run by Sichuan 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 6 inclusion and 6 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 31 May 2018. 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 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 Zhen-Yu Ding, Prof (dingzhenyu@scu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 (time frame: 3 months after the last administration of cells). 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 31 May 2018.