Serplulimab Combined With Anti-VEGF Antibody in Advanced Lung Adenocarcinoma

Sponsor
Fujian Cancer Hospital (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05675033
Collaborator
(none)
50
1
12

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
  • Drug: Serplulimab and Bevacizumab injection
Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
50 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Serplulimab Combined With Anti-VEGF Antibody and Platinum-based Chemotherapy in Treat-naive EGFR/ALK-negative Advanced Lung Adenocarcinoma, a Single Arm Clinical Trail
Anticipated Study Start Date :
Jan 10, 2023
Anticipated Primary Completion Date :
Jan 10, 2023
Anticipated Study Completion Date :
Jan 10, 2024

Arms and Interventions

Arm Intervention/Treatment
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:
  • platinum-based chemotherapy
  • Outcome Measures

    Primary Outcome Measures

    1. 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

    1. ORR [up to 12 months]

      overall response rate

    2. DCR [up to 12 months]

      disease control rate

    3. 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

    Ages Eligible for Study:
    18 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    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.
    Responsible Party:
    Fujian Cancer Hospital
    ClinicalTrials.gov Identifier:
    NCT05675033
    Other Study ID Numbers:
    • SCOG004
    First Posted:
    Jan 9, 2023
    Last Update Posted:
    Jan 9, 2023
    Last Verified:
    Dec 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jan 9, 2023