Serplulimab Combined With Anti-VEGF Antibody in Advanced Lung Adenocarcinoma

NCT05675033 | Unknown Phase 2

• 1 other identifier: SCOG004
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• ORR

  up to 12 months

• DCR

  up to 12 months

• Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

  up to 24 months

Study Arms (1)

study arm

OTHER

This is a single arm study.

Drug: Serplulimab and Bevacizumab injection

Interventions

Serplulimab and Bevacizumab injection DRUG

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.

Also known as: platinum-based chemotherapy

study arm

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fujian Cancer Hospital: lead

MeSH Terms

Conditions

Adenocarcinoma of Lung; Carcinoma, Non-Small-Cell Lung

Interventions

Bevacizumab; Platinum Compounds

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Inorganic Chemicals

Central Study Contacts

Mei Fang Li, MD

CONTACT

+8615985795022; 362952772@qq.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 6, 2022
• First Posted: January 9, 2023
• Study Start: January 10, 2023
• Primary Completion: January 10, 2023
• Study Completion: January 10, 2024
• Last Updated: January 9, 2023

Record last verified: 2022-12