Back to resultsStudy of PD-1 Antibody and PARP Inhibitor in Extensive Stage Small Cell Lung Cancer
Primary Purpose
Small Cell Lung Cancer
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Camrelizumab Anti-PD-1 antibody Fluzoparib PARP inhibitors
Sponsored by
About this trial
This is an interventional treatment trial for Small Cell Lung Cancer
Eligibility Criteria
Inclusion Criteria:
- All subjects were required to sign the informed consent before starting the study;
- Histologically documented Extensive stage small cell lung cancer；
- ECOG PS 0~1 ；
- 18-75 years；
- According to recist1.1, CR or PR was achieved after 4-6 cycles of first-line etoposide and platinum chemotherapy;
- .Life expectancy ≥ 3 months；
Exclusion Criteria:
- Recurrence or distant metastasis of localized small cell lung cancer after chemotherapy or concurrent chemoradiotherapy；
- Active infection including tuberculosis, HIV, hepatitis B and C；
- Interstitial pneumonia (ILD), drug-induced pneumonia, radiation-induced pneumonia requiring steroid therapy or active pneumonia with clinical symptoms, or other moderate to severe lung diseases that seriously affect lung function;
- Severe infection existed, including but not limited to infection complications, bacteremia, severe pneumonia, etc;
- Symptomatic brain metastasis and cancerous meningitis;
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Camrelizumab+Fluzoparib
Arm Description
Outcomes
Primary Outcome Measures
Progression-free survival (PFS)
To assess the efficacy of Camrelizumab and Fluzoparib combination therapy in terms of PFS
Secondary Outcome Measures
Full Information
NCT ID
NCT04782089
First Posted
March 1, 2021
Last Updated
March 1, 2021
Sponsor
Qilu Hospital of Shandong University
Collaborators
Jiangsu HengRui Medicine Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT04782089
Brief Title
Study of PD-1 Antibody and PARP Inhibitor in Extensive Stage Small Cell Lung Cancer
Official Title
A Phase II, Open, Single-center Study of PD-1 Antibody and PARP Inhibitor as Consolidation Treatment for Patients With Extensive Stage Small Cell Lung Cancer Who Have Not Progressed After First-line Treatment
Study Type
Interventional
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Not yet recruiting
Study Start Date
May 6, 2021 (Anticipated)
Primary Completion Date
May 1, 2023 (Anticipated)
Study Completion Date
June 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Qilu Hospital of Shandong University
Collaborators
Jiangsu HengRui Medicine Co., Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
This is a Phase II, Open, Single-center Study of Camrelizumab and Fluzoparib as Consolidation Treatment for Patients With Extensive stage small cell lung cancer Who Have Not Progressed after first-line treatment
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Small Cell Lung Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Camrelizumab+Fluzoparib
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Camrelizumab Anti-PD-1 antibody Fluzoparib PARP inhibitors
Intervention Description
Camrelizumab+Fluzoparib：Q3W, Administration until disease progression or intolerable
Primary Outcome Measure Information:
Title
Progression-free survival (PFS)
Description
To assess the efficacy of Camrelizumab and Fluzoparib combination therapy in terms of PFS
Time Frame
Approximately 3 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
All subjects were required to sign the informed consent before starting the study;
Histologically documented Extensive stage small cell lung cancer；
ECOG PS 0~1 ；
18-75 years；
According to recist1.1, CR or PR was achieved after 4-6 cycles of first-line etoposide and platinum chemotherapy;
.Life expectancy ≥ 3 months；
Exclusion Criteria:
Recurrence or distant metastasis of localized small cell lung cancer after chemotherapy or concurrent chemoradiotherapy；
Active infection including tuberculosis, HIV, hepatitis B and C；
Interstitial pneumonia (ILD), drug-induced pneumonia, radiation-induced pneumonia requiring steroid therapy or active pneumonia with clinical symptoms, or other moderate to severe lung diseases that seriously affect lung function;
Severe infection existed, including but not limited to infection complications, bacteremia, severe pneumonia, etc;
Symptomatic brain metastasis and cancerous meningitis;
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jisheng Li, PhD
Phone
0531-82169841
Email
lijisheng@sdu.edu.cn
12. IPD Sharing Statement
Learn more about this trial
Study of PD-1 Antibody and PARP Inhibitor in Extensive Stage Small Cell Lung Cancer
We'll reach out to this number within 24 hrs