Back to resultsStudy of Sintlimab Maintenance Therapy in Patients With Extensive Small Cell Lung Cancer
Primary Purpose
Small Cell Lung Cancer, Extensive Disease, Adoptive Cellular Immunotherapy
Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
sintilimab maintenance
Sponsored by
About this trial
This is an interventional treatment trial for Small Cell Lung Cancer
Eligibility Criteria
Inclusion Criteria:
- small cell lung cancer confirmed by pathology
- extensive small cell lung cancer by imaging
- at least one measurable lesion by RECIST 1.1
- ECOG 0-1
- adequate organ function
- no other severe diseases conflicting with this regimen (such as autoimmune diseases, immunodeficiency, organ transplantation, etc)
- no history of other maliganancies
- Women of childbearing period must examinate for a negative pregnancy test within 7 days, use appropriate contraceptive measures during the study and 6 months after the trial.
- agreement to participate in the study and signed informed consent from the patients
Exclusion Criteria:
- serious infectious diseases four weeks before enrollment
- requirement intermittent use of bronchodilators or medical interventions;
- the use of immunosuppressants before the enrollment, the amount of immunosuppressant used ≥10mg / day oral prednisone for more than 2 weeks;
- severe allergies
- severe mental disorders
- abnormal coagulation function
- previous or current pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonitis, severe lung damage, etc.
- other situations considered by investigators not meet the inclusion criteria (including but not limited to symptomatic brain metastases)
Sites / Locations
- Affiliated Cancer Hospital of Zhengzhou University & Henan Cancer HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
treatment group
Arm Description
phlebotomation 50ml 1-7 days before chemotherapy for culture of R-CIK cells chemotherapeutic regimen EP or EC as follows: VP-16 100mg/m2 D1-3 plus cisplatin 75mg/m2 D1 or VP-16 100mg/m2 D1-3 plus carboplatin AUC=5 D1 R-CIK cells were transfused back to the patients 2-7 days after the end of chemotherapy, and the amount of R-CIK cells returned each time was about 5×109 three weeks each cycle efficacy evaluated every two cycles patients with the efficay is CR, PR or SD after 4-6 cycles enter the sintilimab maintenance therapy for one year or until the progression of disease, or occurrence of intolerable adverse events. the dose of sintilimab is fixed dose of 200mg every three weeks
Outcomes
Primary Outcome Measures
median survival time
the period from the day of enrollment to the date of death
Secondary Outcome Measures
progression-free survival
the period from the day of enrollment to the date of confirmed progression or death depending on which one occurs first.
objective response rate of sintilimab
from the date of first dose of sintilimab to the date of confirmed progression following
adverse events rate of sintilimab
the rate of adverse events during the maintenance therapy of sintilimab
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03983759
Brief Title
Study of Sintlimab Maintenance Therapy in Patients With Extensive Small Cell Lung Cancer
Official Title
Clinical Study of Sequential Sequential Sintilimab Maintenance Therapy in Patients With Extensive Small Cell Lung Cancer After Chemotherapy Combined With Adoptive Cellular Immunotherapy
Study Type
Interventional
2. Study Status
Record Verification Date
June 2019
Overall Recruitment Status
Unknown status
Study Start Date
June 20, 2019 (Actual)
Primary Completion Date
May 31, 2021 (Anticipated)
Study Completion Date
May 31, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Henan Cancer Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Small cell lung cancer is a highly aggressive malignancy. Currently, there is no effective regimen for patients after the progression offirst-line chemotherapy. The prognosis of patients with extensive disease is very poor, and the improved therapeutic efficacy is urgently needed. Most patients with small cell lung cancer have a long history of smoking, and the tumor mutation burden is relatively high, which provides potential for immunological checkpoint inhibitors represented by PD-1 antibodies. A number of studies have shown that chemotherapy combined with adoptive cellular immunotherapy could prolong the survival of patients. This study is a clinical study to explore the efficacy and safety of maintenance therapy with sintilimab after 4-6 cycles of first-line chemotherapy combined with adoptive cellular immunotherapy in patients with advanced small cell lung cancer.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Small Cell Lung Cancer, Extensive Disease, Adoptive Cellular Immunotherapy, Chemotherapy, Maintenance
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
treatment group
Arm Type
Experimental
Arm Description
phlebotomation 50ml 1-7 days before chemotherapy for culture of R-CIK cells chemotherapeutic regimen EP or EC as follows: VP-16 100mg/m2 D1-3 plus cisplatin 75mg/m2 D1 or VP-16 100mg/m2 D1-3 plus carboplatin AUC=5 D1 R-CIK cells were transfused back to the patients 2-7 days after the end of chemotherapy, and the amount of R-CIK cells returned each time was about 5×109 three weeks each cycle efficacy evaluated every two cycles patients with the efficay is CR, PR or SD after 4-6 cycles enter the sintilimab maintenance therapy for one year or until the progression of disease, or occurrence of intolerable adverse events.
the dose of sintilimab is fixed dose of 200mg every three weeks
Intervention Type
Drug
Intervention Name(s)
sintilimab maintenance
Intervention Description
the patients with CR, PR or SD after the chemotherapy plus R-CIK will receive sintilimab maintenance therapy. The dose of sintilimab is fixed at 200mg every three weeks.
Primary Outcome Measure Information:
Title
median survival time
Description
the period from the day of enrollment to the date of death
Time Frame
two years.
Secondary Outcome Measure Information:
Title
progression-free survival
Description
the period from the day of enrollment to the date of confirmed progression or death depending on which one occurs first.
Time Frame
six months
Title
objective response rate of sintilimab
Description
from the date of first dose of sintilimab to the date of confirmed progression following
Time Frame
six month
Title
adverse events rate of sintilimab
Description
the rate of adverse events during the maintenance therapy of sintilimab
Time Frame
one year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
small cell lung cancer confirmed by pathology
extensive small cell lung cancer by imaging
at least one measurable lesion by RECIST 1.1
ECOG 0-1
adequate organ function
no other severe diseases conflicting with this regimen (such as autoimmune diseases, immunodeficiency, organ transplantation, etc)
no history of other maliganancies
Women of childbearing period must examinate for a negative pregnancy test within 7 days, use appropriate contraceptive measures during the study and 6 months after the trial.
agreement to participate in the study and signed informed consent from the patients
Exclusion Criteria:
serious infectious diseases four weeks before enrollment
requirement intermittent use of bronchodilators or medical interventions;
the use of immunosuppressants before the enrollment, the amount of immunosuppressant used ≥10mg / day oral prednisone for more than 2 weeks;
severe allergies
severe mental disorders
abnormal coagulation function
previous or current pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonitis, severe lung damage, etc.
other situations considered by investigators not meet the inclusion criteria (including but not limited to symptomatic brain metastases)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Quanli Gao, Dr.
Phone
+86-15038171966
Email
gaoquanli2015@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jing Ding, Master
Organizational Affiliation
Henan Cancer Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Affiliated Cancer Hospital of Zhengzhou University & Henan Cancer Hospital
City
Zhengzhou
State/Province
Henan
ZIP/Postal Code
450008
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Quanli Gao, M.D
Phone
+86-371-65587795
Email
gaoquanli2015@126.com
First Name & Middle Initial & Last Name & Degree
Lingdi Zhao, M.D.
Phone
+86-371-65587483
Email
lingdizhao@126.com
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
36158690
Citation
Ma B, Zhou Y, Shang Y, Zhang Y, Xu B, Fu X, Guo J, Yang Y, Zhang F, Zhou M, Huang H, Li F, Lin H, Zhao L, Wang Z, Gao Q. Sintilimab maintenance therapy post first-line cytokine-induced killer cells plus chemotherapy for extensive-stage small cell lung cancer. Front Oncol. 2022 Sep 9;12:852885. doi: 10.3389/fonc.2022.852885. eCollection 2022.
Results Reference
derived
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Study of Sintlimab Maintenance Therapy in Patients With Extensive Small Cell Lung Cancer
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