Serplulimab Combined With Anti-VEGF Antibody in Advanced Lung Adenocarcinoma

Study Overview
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Brief Summary
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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.

Official Title
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Serplulimab Combined With Anti-VEGF Antibody and Platinum-based Chemotherapy in Treat-naive EGFR/ALK-negative Advanced Lung Adenocarcinoma, a Single Arm Clinical Trail

Conditions
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Lung Adenocarcinoma, Stage IV Non-small Cell Lung Cancer, PD-1 Inhibitor, VEGF

Intervention / Treatment
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* Drug: Serplulimab and Bevacizumab injection


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: study arm<br>This is a single arm study. | Drug: Serplulimab and Bevacizumab injection<br>* 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.<br>* Other names: platinum-based chemotherapy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PFS | progression-free survival | 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 Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ORR | overall response rate | up to 12 months | 
| DCR | disease control rate | up to 12 months | 
| 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 | up to 24 months |