Lung Adenocarcinoma, PD-1 Inhibitor, Stage IV Non-small Cell Lung Cancer, VEGF
Conditions
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.
Interventions
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.
Sponsors
Fujian Cancer Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Contacts
Primary ContactMei Fang Li, MD
Outcome results
None listed