Back to resultsNK Cell-based Immunotherapy as Maintenance Therapy for Small-Cell Lung Cancer.
Primary Purpose
Small Cell Lung Cancer
Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
NK cells
Sponsored by
About this trial
This is an interventional treatment trial for Small Cell Lung Cancer focused on measuring maintenance therapy, immunotherapy, adoptive cell transfer, natural killer cell
Eligibility Criteria
Inclusion Criteria:
- Histologically or cytologically confirmed small cell lung cancer.
- Having completed first-line therapy in the presence of stable disease (SD), partial remission (PR) or complete remission (CR) status.
- Age ≥18 years.
- Karnofsky Performance Status (KPS) ≥80.
- Important organs:cardiac ejection fraction >50%; Pulse Oxygen Saturation(SpO2) >90%; creatinine (Cr) ≤ 2.5 times the normal range; alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤3 times the normal range, total bilirubin (TBIL)≤2.0mg/dl (34.2umol/L);Hgb≥60g/L.
- Without contraindication of apheresis and cell isolation.
- Patients and their families having the willingness to participate in clinical trial with signed written informed consent.
Exclusion Criteria:
- Patient having an active rheumatic immunologic disease.
- Uncontrolled bacterial, fungal or viral infection.
- human immunodeficiency virus(HIV), hepatitis B virus infection(HBV), hepatitis C virus(HCV) infection.
- History of organ transplantation and hemopoietic stem cell transplantation.
- Pregnant or lactating women.
- Patients using immunosuppressive agents within the first 3 months of the study or received glucocorticoid systemic therapy within a week prior to entry into the study.
- Patients receiving other immunotherapy after diagnosis.
Sites / Locations
- the First Hospital of Jilin UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
autologous natural killer cells
routine follow-up
Arm Description
Infusion of 1-2×10^9 NK cells every 14 days in the absence of progression or unacceptable toxicity until the 6 courses of treatment.
According to present guideline, no special treatment is advised for patients with SCLC after first-line therapy.They will be followed-up regularly.
Outcomes
Primary Outcome Measures
Progression-free survival(PFS)
Progression-free survival is defined as the time from randomization to first observation of progression or date of death (from any cause). Progression will be evaluated according to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1. Patients who do not progress or not die will be censored on the date of their last tumor assessment, i.e. on the last date that we really know that the patient is considered as "progression-free".
Secondary Outcome Measures
Overall survival(OS)
Overall survival, defined as the time from randomization until death due to any cause. For patients who do not die, time to death will be censored at the time of the last contact.
Evaluate the change of the quality of life for all patients
Patients' quality-of-life will be assessed by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 and European Organization for Research and Treatment of Cancer Quality of Life Questionnaire LC-13 at baseline and after every two courses of adoptive cellular transfer in study group or every visit in control group.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03410368
Brief Title
NK Cell-based Immunotherapy as Maintenance Therapy for Small-Cell Lung Cancer.
Official Title
A Randomized, Controlled, Open-label, Single Center, Phase II Study to Evaluate the Efficacy and Safety of NK Cell-based Immunotherapy as Maintenance Therapy for Patients With Small-cell Lung Cancer After First-line Chemotherapy.
Study Type
Interventional
2. Study Status
Record Verification Date
July 2018
Overall Recruitment Status
Unknown status
Study Start Date
April 1, 2018 (Actual)
Primary Completion Date
June 1, 2019 (Anticipated)
Study Completion Date
July 1, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
jiuwei cui
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Natural killer (NK) cells can kill a broad array of tumor cells in a non-major histocompatibility complex(MHC)-restricted manner. Adoptive transfer of NK may prolong the survival of patients with cancer. This study evaluates the efficacy and safety of NK cell-based immunotherapy for small-cell lung cancer (SCLC) after first-line chemotherapy. Half of the participants will receive autologous adoptive transfer of NK cells after the response from first-line chemotherapy, while the other half will be followed up in routine clinal practice.
Detailed Description
The small-cell lung cancer (SCLC) is very sensitive to the standard-of-care first-line chemotherapy and/or radiotherapy, but it will ultimately progress or relapse and develop early resistance to conventional treatments. No effective maintenance therapy except for wath and wait after first-line therapy at present.
NK cells constitute the major component of the innate immune system and kill tumor cells in a non-MHC-restricted manner. In our previous pilot study and other reports, adoptive transfer of autologous NK cells expanded ex vivo was very well tolerant and effective.
There is no prospective trial on the maintenance therapy of SCLC after first-line chemotherapy based on autologous NK cells. The purpose of this phase II clinical research is to evaluate the efficacy and safety of autologous NK cells as the maintenance therapy after the first-line treatment, comparing with conventional observation group.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Small Cell Lung Cancer
Keywords
maintenance therapy, immunotherapy, adoptive cell transfer, natural killer cell
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
Patients with small-cell lung cancer receive autologous NK cells adoptive cancer immunotherapy as a maintenance therapy in the presence of stable disease (SD), partial remission (PR) or complete remission (CR) after the first-line chemotherapy.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
autologous natural killer cells
Arm Type
Experimental
Arm Description
Infusion of 1-2×10^9 NK cells every 14 days in the absence of progression or unacceptable toxicity until the 6 courses of treatment.
Arm Title
routine follow-up
Arm Type
No Intervention
Arm Description
According to present guideline, no special treatment is advised for patients with SCLC after first-line therapy.They will be followed-up regularly.
Intervention Type
Biological
Intervention Name(s)
NK cells
Intervention Description
Autologous peripheral blood mononuclear cells (PBMCs) are collected by apheresis on D0, then induced into NK cells and infused into the patients 14 days later (D14) as the initial transfusion. There are 3 consecutive transfusion days (D14-D16). The second course of PBMCs collection started D14 before infusion. A total of 6 courses will be completed unless progression or unacceptable adverse events.
Primary Outcome Measure Information:
Title
Progression-free survival(PFS)
Description
Progression-free survival is defined as the time from randomization to first observation of progression or date of death (from any cause). Progression will be evaluated according to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1. Patients who do not progress or not die will be censored on the date of their last tumor assessment, i.e. on the last date that we really know that the patient is considered as "progression-free".
Time Frame
20 months
Secondary Outcome Measure Information:
Title
Overall survival(OS)
Description
Overall survival, defined as the time from randomization until death due to any cause. For patients who do not die, time to death will be censored at the time of the last contact.
Time Frame
20 months
Title
Evaluate the change of the quality of life for all patients
Description
Patients' quality-of-life will be assessed by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 and European Organization for Research and Treatment of Cancer Quality of Life Questionnaire LC-13 at baseline and after every two courses of adoptive cellular transfer in study group or every visit in control group.
Time Frame
20 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Histologically or cytologically confirmed small cell lung cancer.
Having completed first-line therapy in the presence of stable disease (SD), partial remission (PR) or complete remission (CR) status.
Age ≥18 years.
Karnofsky Performance Status (KPS) ≥80.
Important organs:cardiac ejection fraction >50%; Pulse Oxygen Saturation(SpO2) >90%; creatinine (Cr) ≤ 2.5 times the normal range; alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤3 times the normal range, total bilirubin (TBIL)≤2.0mg/dl (34.2umol/L);Hgb≥60g/L.
Without contraindication of apheresis and cell isolation.
Patients and their families having the willingness to participate in clinical trial with signed written informed consent.
Exclusion Criteria:
Patient having an active rheumatic immunologic disease.
Uncontrolled bacterial, fungal or viral infection.
human immunodeficiency virus(HIV), hepatitis B virus infection(HBV), hepatitis C virus(HCV) infection.
History of organ transplantation and hemopoietic stem cell transplantation.
Pregnant or lactating women.
Patients using immunosuppressive agents within the first 3 months of the study or received glucocorticoid systemic therapy within a week prior to entry into the study.
Patients receiving other immunotherapy after diagnosis.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
lei qian, MD
Phone
13086891158
Email
qianlei_cool@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
jiuwei cui, PhD
Organizational Affiliation
the Cancer Center of First Hospital of Jilin University
Official's Role
Principal Investigator
Facility Information:
Facility Name
the First Hospital of Jilin University
City
Ch'ang-ch'un
State/Province
Jilin
ZIP/Postal Code
130021
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
xuan j li, master
Phone
18844194678
Email
1776514587@qq.com
First Name & Middle Initial & Last Name & Degree
lei qian, master
Phone
15843139762
Email
qianlei_cool@126.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
NK Cell-based Immunotherapy as Maintenance Therapy for Small-Cell Lung Cancer.
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