Back to resultsSerplulimab Combined With Anti-VEGF Antibody in Advanced Lung Adenocarcinoma
Primary Purpose
Lung Adenocarcinoma, Stage IV Non-small Cell Lung Cancer, PD-1 Inhibitor
Status
Not yet recruiting
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Serplulimab and Bevacizumab injection
Sponsored by
About this trial
This is an interventional treatment trial for Lung Adenocarcinoma
Eligibility Criteria
Inclusion Criteria: Fully understood this study and voluntarily signed the informed consent form (ICF); -≥ 18 years and ≤ 75 years old; ECOG score 0-1; Non-squamous NSCLC; stage IV; EGFR and ALK negative; Treatment-naive; According to RECIST1.1 criteria, there are measurable or evaluable lesions. Exclusion Criteria: Tumor histology or cytology confirmed that it was associated with squamous cell carcinoma or small cell lung cancer; Patients with severe organ dysfunction were indicated by examination, Exclude subjects with any active, known or suspected autoimmune diseases; The estimated survival time is less than 3 months.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
study arm
Arm Description
This is a single arm study.
Outcomes
Primary Outcome Measures
PFS
progression-free survival
Secondary Outcome Measures
ORR
overall response rate
DCR
disease control rate
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Number of Participants With Abnormal Laboratory Values and/or Adverse Events That Are Related to Treatment
Full Information
NCT ID
NCT05675033
First Posted
December 6, 2022
Last Updated
December 21, 2022
Sponsor
Fujian Cancer Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05675033
Brief Title
Serplulimab Combined With Anti-VEGF Antibody in Advanced Lung Adenocarcinoma
Official Title
Serplulimab Combined With Anti-VEGF Antibody and Platinum-based Chemotherapy in Treat-naive EGFR/ALK-negative Advanced Lung Adenocarcinoma, a Single Arm Clinical Trail
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
January 10, 2023 (Anticipated)
Primary Completion Date
January 10, 2023 (Anticipated)
Study Completion Date
January 10, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fujian Cancer Hospital
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
In order to further evaluate the efficacy of immunotherapy combined with antivascular therapy in the real world, we used Serpluimab combined with Bevacizumab and platinum-based chemotherapy in previously untreated EGFR/ALK-negative advanced non-squamous NSCLC patients, to evaluate the efficacy and safety of this regimen.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Adenocarcinoma, Stage IV Non-small Cell Lung Cancer, PD-1 Inhibitor, VEGF
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
study arm
Arm Type
Other
Arm Description
This is a single arm study.
Intervention Type
Drug
Intervention Name(s)
Serplulimab and Bevacizumab injection
Other Intervention Name(s)
platinum-based chemotherapy
Intervention Description
Serplulimab, 4.5mg/kg, intravenous injection, D1,Q21, until the disease progressed or showed intolerable side effects.
Bevacizumab injection, 7.5mg/kg, intravenous injection, D1, Q21, until the disease progressed or showed intolerable side effects.
Platinum-based chemotherapy: pemetrexed combined with carboplatin, D1-2, Q21, a total of 4 cycles.
Primary Outcome Measure Information:
Title
PFS
Description
progression-free survival
Time Frame
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
Secondary Outcome Measure Information:
Title
ORR
Description
overall response rate
Time Frame
up to 12 months
Title
DCR
Description
disease control rate
Time Frame
up to 12 months
Title
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Description
Number of Participants With Abnormal Laboratory Values and/or Adverse Events That Are Related to Treatment
Time Frame
up to 24 months
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:
Fully understood this study and voluntarily signed the informed consent form (ICF);
-≥ 18 years and ≤ 75 years old;
ECOG score 0-1;
Non-squamous NSCLC;
stage IV;
EGFR and ALK negative;
Treatment-naive;
According to RECIST1.1 criteria, there are measurable or evaluable lesions.
Exclusion Criteria:
Tumor histology or cytology confirmed that it was associated with squamous cell carcinoma or small cell lung cancer;
Patients with severe organ dysfunction were indicated by examination, Exclude subjects with any active, known or suspected autoimmune diseases;
The estimated survival time is less than 3 months.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mei Fang Li, MD
Phone
+8615985795022
Email
362952772@qq.com
12. IPD Sharing Statement
Learn more about this trial
Serplulimab Combined With Anti-VEGF Antibody in Advanced Lung Adenocarcinoma
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