Serplulimab Combined With Anti-VEGF Antibody in Advanced Lung Adenocarcinoma

Stage IV Non-small Cell Lung Cancer Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05675033
• Other study ID #: SCOG004
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: January 10, 2023
• Est. completion date: January 10, 2024

Study information

• Verified date: December 2022
• Source: Fujian Cancer Hospital
• Contact: Mei Fang Li, MD
• Phone: +8615985795022
• Email: 362952772[@]qq.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: January 10, 2024
• Est. primary completion date: January 10, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Adenocarcinoma
• Adenocarcinoma of Lung
• Lung Adenocarcinoma
• Stage IV Non-small Cell Lung Cancer
• VEGF

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Fujian Cancer Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	ORR	overall response rate	up to 12 months
Secondary	DCR	disease control rate	up to 12 months
Secondary	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