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Trial Title:
Serplulimab Combined With Anti-VEGF Antibody in Advanced Lung Adenocarcinoma
NCT ID:
NCT05675033
Condition:
Lung Adenocarcinoma
Stage IV Non-small Cell Lung Cancer
PD-1 Inhibitor
VEGF
Conditions: Official terms:
Adenocarcinoma
Adenocarcinoma of Lung
Bevacizumab
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Serplulimab and Bevacizumab injection
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.
Arm group label:
study arm
Other name:
platinum-based chemotherapy
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.
Criteria for 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Start date:
January 10, 2023
Completion date:
January 10, 2024
Lead sponsor:
Agency:
Fujian Cancer Hospital
Agency class:
Other
Source:
Fujian Cancer Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05675033
