Carcinoma, Non-Small-Cell Lung
Conditions
Brief summary
The trial was a randomized, open-label, multicenter Phase II study of patients with advanced or metastatic NSCLC who don't harbor driver genes. The aim is to explore the efficacy and safety of Envafolimab Combined With Endostar/S-1 in second-line treatment of advanced non-small cell lung cancer.
Detailed description
Patients with advanced (stage IV. NSCLC), after signing informed consent, are screened to meet the admission requirements. All the candidates are not randomly placed in 3 treatment groups (which treatment regimen the patient chooses is determined by the clinical supervisor on a patient-by-case basis).
Interventions
DRUGEnvafolimab plus Endostar and S-1
Immunotherapy combined with chemotherapy and anti VEGFR therapy
DRUGEnvafolimab plus Endostar
Immunotherapy combined with anti VEGFR therapy
DRUGEnvafolimab plus S-1
Immunotherapy combined with chemotherapy
Sponsors
Anhui Chest Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. All patients are histologically or cytologically confirmed stage IV non-small cell lung cancer. Genetic testing identifies no driver gene mutations. 2. Male or female, age \> 18 years, \< 75 years. 3. Patients had not received PD-L1 inhibitors in first-line treatment. 4. KPS score ≥ 70 points (ECOG score 0-1 points), the expected survival ≥3 months; 5. No dysfunction of major organs. EcG, liver function, renal function, and blood count tests before treatment are normal or basically normal, but must meet the following experimental results: 1. Blood routine test: Leukocyte WBC≥3.5×109/L; Neutrophil count (ANC) ≥ 1.5×109/L; Platelet (PLT) ≥ 80×109/L; 2. Blood biochemical test: Total bilirubin (TBIL) ≤ 1.5 times the upper limit of normal values; Alanine aminotransferase (ALT/SGPT) and alanine transaminases (AST/SGOT) ≤ 2.5 times the normal high value (ULN), or ≤ 5 times the upper limit of normal value in patients with liver metastases; Serum creatinine (Cr) ≤ 1.5 times the upper limit of normal values; c. Cardiac function test: 50% of the left ventricular ejection function of the heart \>; 6) The subject has good compliance, and can cooperates with follow-up.
Exclusion criteria
\-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| objective response rate(ORR) | six weeks | proportion of patients with a complete response or partial response to treatment according to Response Evaluation Criteria in Solid Tumors |
| Adverse events | three weeks | safety |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| progression-free survival(PFS) | six weeks | the time from initial treatment to disease progression |
| overall survival(OS) | six weeks | the time from initial treatment to death from any cause |
Outcome results
None listed