Overview

Effect and Safety of Envafolimab Combined With Endostar/S-1 in Second-line of Advanced Non-small Cell Lung Cancer

Status:
Not yet recruiting

Trial end date:
2023-09-18

Target enrollment:
0

Participant gender:
All

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.

Phase:

Phase 2

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Anhui Chest Hospital

Treatments:

Endostar protein
Endostatins
Tegafur

Criteria

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:

-