Serplulimab Combined With Anti-VEGF Antibody in Advanced Lung Adenocarcinoma
Study Details
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.
Condition or Disease | Intervention/Treatment | Phase |
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Phase 2 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Other: study arm This is a single arm study. |
Drug: Serplulimab and Bevacizumab injection
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.
Other Names:
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Outcome Measures
Primary Outcome Measures
- PFS [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]
progression-free survival
Secondary Outcome Measures
- ORR [up to 12 months]
overall response rate
- DCR [up to 12 months]
disease control rate
- Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] [up to 24 months]
Number of Participants With Abnormal Laboratory Values and/or Adverse Events That Are Related to Treatment
Eligibility Criteria
Criteria
Inclusion Criteria:
- Fully understood this study and voluntarily signed the informed consent form (ICF);
-≥ 18 years and ≤ 75 years old;
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ECOG score 0-1;
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Non-squamous NSCLC;
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stage IV;
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EGFR and ALK negative;
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Treatment-naive;
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According to RECIST1.1 criteria, there are measurable or evaluable lesions.
Exclusion Criteria:
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Tumor histology or cytology confirmed that it was associated with squamous cell carcinoma or small cell lung cancer;
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Patients with severe organ dysfunction were indicated by examination, Exclude subjects with any active, known or suspected autoimmune diseases;
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The estimated survival time is less than 3 months.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Fujian Cancer Hospital
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- SCOG004