Non-small Cell Lung CancerPhase 2ANKL-2NCT02370017
Combined Effect of Natural Killer Cell and Doublet Chemotherapy in Advanced NSCLC as the 1st Line Treatment
A Phase 2 study testing ANKL(Ex vivo-expanded NK cell enriched lymphocytes) in people with Non-small Cell Lung Cancer, run by The Catholic University of Korea at 1 site in South Korea.
Trial summary
The object of this study is to identify the combined effect of ANKL and doublet chemotherapy in advanced NSCLC. The investigators design the combination of ANKL and approved chemotherapy as the 3rd and 4th courses in the patients who get stable response after x2 induction as the first line chemotherapy. Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Non-small Cell Lung Cancer
- What is being tested?
- ANKL(Ex vivo-expanded NK cell enriched lymphocytes)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteSouth Korea
- Study dates
- Feb 2015to Feb 2020
- 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 20 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- advanced NSCLC with measurable lesions,
- age of 20 - 75 years, Eastern Cooperative Oncology Group (ECOG)
- performance status (PS) of 0 to 2, and stable response after x2 induction chemotherapy as first line treatment.
- No major organ dysfunction.
Who cannot join
- pregnant or lactating woman,
- active hepatitis B or C,
- AIDS or positivity for HIV, autoimmune diseases or treatment with immunosuppressive drugs,
- prior radiotherapy to the target region
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Daejeon St. Mary's Hospital
Jung-gu, Daejeon, 34943
Suk Young Park, MD, PhD, 82-42-220-9821, sypark1011@hotmail.com
young Jun Yang, MD, 82-10-6435-7009, yyj7009@daum.net
About this study
Official title: Combined Effect of Autologous Ex-vivo Expanded Activated NK Cell-lymphocytes (ANKL) and Doublet Chemotherapy in Patients With Advanced NSCLC as the 1st Line Treatment; Phase II
The object of this study is to identify the combined effect of ANKL and doublet chemotherapy in advanced NSCLC. The investigators design the combination of ANKL and approved chemotherapy as the 3rd and 4th courses in the patients who get stable response after x2 induction as the first line chemotherapy. ANKL (2x10*9) from peripheral blood 32ml is administered rapidly iv 12-36hr after each chemotherapeutic agents while peak effect of NK cell ligand modulation by chemotherapeutic agent is maintained. After 4th course, response evaluation is done by Response Evaluation Criteria in Solid Tumors (RECIST) and 40% or more partial response (PR, increased by 15% or more from historical control 25%) is the expected target and Simon's two stage design will be applied through the study (power 80%, a= 0.95, N1= 33, N= 68)
Read the detailed description
Based on additive or synergistic effect of natural killer (NK) cell and chemotherapy (modulating the expression of NK stimulatory ligand on tumor cell), the investigators performed phase II trial of docetaxel and ANKL combination s the second line treatment in advanced non-small cell lung cancer (NSCLN) and reported the results in May 2013. (Anticancer Research 33;2115, Poster Presentation in ASCO).In that study, the investigators observed the feasibility and safety of ANKL combined with docetaxel in patients with advanced NSCLC, but the clinical benefit was not evaluated properly because the study was interrupted unintentionally and most of the enrolled patients were far advanced with large tumor burden, that is, poor immunological environment for ANKL to work.
The object of this study is to identify the combined effect of ANKL and doublet chemotherapy in advanced NSCLC. The approved doublet chemotherapy based on platinum is widely used with the response rate (RR) 25-35% after 4-6 courses as the first line treatment. The investigators design the combination of ANKL and chemotherapy as the 3rd and 4th courses in the patients who show stable response after x2 courses. Higher RR with the combination treatment is the primary outcome as compared with the chemotherapy alone - historical control; about 12% PR and 50% stable response after x2 initial courses and 25% PR after x2 more courses among the patients who get stable response after x2 initial courses. Peripheral blood 32 ml will be drawn from the patients who decide to be enrolled and about 2 weeks later ANKL (2x10*9) are scheduled to be administered rapidly iv 12-36hr after each chemotherapeutic agents while peak effect of NK cell ligand modulation by chemotherapeutic agent is maintained. After 4th course, response evaluation is done by RECIST and 40% or more PR (increased by 15% or more from historical control 25%) is the expected target and Simon's two stage design will be applied through the study (power 80%, a= 0.95, N1= 33, N= 68)
- Conditions
- Non-small Cell Lung Cancer
- Being tested
- ANKL(Ex vivo-expanded NK cell enriched lymphocytes)
- Keywords
- Autologous Ex vivo-expanded NK cell enriched lymphocytes
- 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.
ANKL(Ex vivo-expanded NK cell enriched lymphocytes)Biological
add ANKL in 3rd and 4th course in case of stable response after two initial courses
| Study group | Role | What they receive |
|---|---|---|
| ANKL combined with chemotherapy | Experimental | combination of ANKL and doublet chemotherapy as 3rd and 4th course in patients who get stable response after initial x2 courses Receives: Biological: ANKL(Ex vivo-expanded NK cell enriched lymphocytes) |
What is being measured
The primary outcome is the main question the study is designed to answer.
response rate
confirmed response rate by CT scan
Measured: 1 month later after 4th course
Secondary outcomes (1)
progression free survival
CT or other imaging modality
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2015 (estimated)
- Study startFeb 2015
- Primary completionAug 2018 (estimated)
- Study completionFeb 2020 (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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 68 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Catholic University of Korea
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Suk Young Park, M.D.-Ph.D., The Catholic University of Korea
- Investigators
- Suk Young Park, MD, PhD, Principal investigator, The Catholic University of KoreaHoon Kim, MD, PhD, Study director, The Catholic University of Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02370017
- Sponsor's protocol ID
- CUMC-ANKL-002
- Acronym
- ANKL-2
- Status last verified
- Feb 2017
- First submitted
- 1 Feb 2015
- Last updated
- 3 Feb 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combined Effect of Autologous Ex-vivo Expanded Activated NK Cell-lymphocytes (ANKL) and Doublet Chemotherapy in Patients With Advanced NSCLC as the 1st Line Treatment; Phase II
- ClinicalTrials.gov ID
- NCT02370017
- Acronym / sponsor ID
- ANKL-2 / CUMC-ANKL-002
- Conditions
- Non-small Cell Lung Cancer
- Keywords
- Autologous Ex vivo-expanded NK cell enriched lymphocytes
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 68 participants (estimated)
- Lead sponsor
- The Catholic University of KoreaUniversity, hospital or other
- Study start
- Feb 2015
- Primary completion
- Aug 2018 (estimated)
- Study completion
- Feb 2020 (estimated)
- First posted
- 24 Feb 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 object of this study is to identify the combined effect of ANKL and doublet chemotherapy in advanced NSCLC. The investigators design the combination of ANKL and approved chemotherapy as the 3rd and 4th courses in the patients who get stable response after x2 induction as the first line chemotherapy. ANKL (2x10*9) from peripheral blood 32ml is administered rapidly iv 12-36hr after each chemotherapeutic agents while peak effect of NK cell ligand modulation by chemotherapeutic agent is maintained. After 4th course, response evaluation is done by Response Evaluation Criteria in Solid Tumors (RECIST) and 40% or more partial response (PR, increased by 15% or more from historical control 25%) is the expected target and Simon's two stage design will be applied through the study (power 80%, a= 0.95, N1= 33, N= 68)
Detailed description
Based on additive or synergistic effect of natural killer (NK) cell and chemotherapy (modulating the expression of NK stimulatory ligand on tumor cell), the investigators performed phase II trial of docetaxel and ANKL combination s the second line treatment in advanced non-small cell lung cancer (NSCLN) and reported the results in May 2013. (Anticancer Research 33;2115, Poster Presentation in ASCO).In that study, the investigators observed the feasibility and safety of ANKL combined with docetaxel in patients with advanced NSCLC, but the clinical benefit was not evaluated properly because the study was interrupted unintentionally and most of the enrolled patients were far advanced with large tumor burden, that is, poor immunological environment for ANKL to work.
The object of this study is to identify the combined effect of ANKL and doublet chemotherapy in advanced NSCLC. The approved doublet chemotherapy based on platinum is widely used with the response rate (RR) 25-35% after 4-6 courses as the first line treatment. The investigators design the combination of ANKL and chemotherapy as the 3rd and 4th courses in the patients who show stable response after x2 courses. Higher RR with the combination treatment is the primary outcome as compared with the chemotherapy alone - historical control; about 12% PR and 50% stable response after x2 initial courses and 25% PR after x2 more courses among the patients who get stable response after x2 initial courses. Peripheral blood 32 ml will be drawn from the patients who decide to be enrolled and about 2 weeks later ANKL (2x10*9) are scheduled to be administered rapidly iv 12-36hr after each chemotherapeutic agents while peak effect of NK cell ligand modulation by chemotherapeutic agent is maintained. After 4th course, response evaluation is done by RECIST and 40% or more PR (increased by 15% or more from historical control 25%) is the expected target and Simon's two stage design will be applied through the study (power 80%, a= 0.95, N1= 33, N= 68)
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ANKL combined with chemotherapy | Experimental | Biological: ANKL(Ex vivo-expanded NK cell enriched lymphocytes)combination of ANKL and doublet chemotherapy as 3rd and 4th course in patients who get stable response after initial x2 courses |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- advanced NSCLC with measurable lesions,
- age of 20 - 75 years, Eastern Cooperative Oncology Group (ECOG)
- performance status (PS) of 0 to 2, and stable response after x2 induction chemotherapy as first line treatment.
- No major organ dysfunction.
Key exclusion criteria (4 listed)
- pregnant or lactating woman,
- active hepatitis B or C,
- AIDS or positivity for HIV, autoimmune diseases or treatment with immunosuppressive drugs,
- prior radiotherapy to the target region
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 |
|---|---|---|
| ANKL(Ex vivo-expanded NK cell enriched lymphocytes)add ANKL in 3rd and 4th course in case of stable response after two initial courses | Biological | ANKL combined with chemotherapy |
Primary outcome
response rate
Time frame: 1 month later after 4th course
confirmed response rate by CT scan
1 secondary outcome
progression free survival
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2017.
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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.
Suk Young Park, MD, PhD principal investigator
The Catholic University of Korea
Hoon Kim, MD, PhD study director
The Catholic University of Korea
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ANKL(Ex vivo-expanded NK cell enriched lymphocytes) in people with Non-small Cell Lung Cancer, run by The Catholic University of Korea at 1 site in South Korea.
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 4 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 Feb 2017. 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 South Korea. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Bo Ra Hong, RN (+82-10-6402-9535, shbrp@hanmail.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
response rate (time frame: 1 month later after 4th course). 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 Feb 2017.