Serplulimab Combined With Anti-VEGF Antibody in Advanced Lung Adenocarcinoma

Fujian Cancer Hospital50 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

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

Interventions

Serplulimab and Bevacizumab injectionDRUG

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

PFS

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 Outcomes

ORR

overall response rate

Time frame: up to 12 months

DCR

disease control rate

Time frame: 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

Time frame: up to 24 months

Central Contacts

Mei Fang Li, MD

CONTACT

+8615985795022 362952772@qq.com

Data from ClinicalTrials.gov

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