Combined Effect of Natural Killer Cell and Doublet Chemotherapy in Advanced NSCLC as the 1st Line Treatment
NCT ID: NCT02370017
Last Updated: 2017-02-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
68 participants
INTERVENTIONAL
2015-02-28
2020-02-29
Brief Summary
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Detailed Description
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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
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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ANKL combined with chemotherapy
combination of ANKL and doublet chemotherapy as 3rd and 4th course in patients who get stable response after initial x2 courses
ANKL(Ex vivo-expanded NK cell enriched lymphocytes)
add ANKL in 3rd and 4th course in case of stable response after two initial courses
Interventions
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ANKL(Ex vivo-expanded NK cell enriched lymphocytes)
add ANKL in 3rd and 4th course in case of stable response after two initial courses
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* active hepatitis B or C,
* AIDS or positivity for HIV, autoimmune diseases or treatment with immunosuppressive drugs,
* prior radiotherapy to the target region
20 Years
75 Years
ALL
No
Sponsors
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The Catholic University of Korea
OTHER
Responsible Party
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Suk Young Park, M.D.-Ph.D.
Professor, Medical Oncology, Dept of Internal Medicine
Principal Investigators
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Suk Young Park, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
The Catholic University of Korea
Hoon Kim, MD, PhD
Role: STUDY_DIRECTOR
The Catholic University of Korea
Locations
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Daejeon St. Mary's Hospital
Jung-gu, Daejeon, South Korea
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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CUMC-ANKL-002
Identifier Type: -
Identifier Source: org_study_id
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