Serplulimab Combined With Anti-VEGF Antibody in Advanced Lung Adenocarcinoma

Phase 2

Not yet recruiting

• Conditions: Lung Adenocarcinoma; Stage IV Non-small Cell Lung Cancer; PD-1 Inhibitor; VEGF
• Interventions: Drug: Serplulimab and Bevacizumab injection

• Registration Number: NCT05675033
• Lead Sponsor: Fujian Cancer Hospital

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2022-12
• Study First Submitted: 2022-12-06
• Study First Submitted QC: 2022-12-21
• Last Update Submitted: 2022-12-21
• Study First Posted: 2023-01-09
• Last Update Posted: 2023-01-09
• Study Start: 2023-01-10
• Primary Completion: 2023-01-10
• Study Completion: 2024-01-10

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 50

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
study arm	Serplulimab and Bevacizumab injection	This is a single arm study.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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