To hear about similar clinical trials, please enter your email below
Trial Title:
Effect and Safety of Envafolimab Combined With Endostar/S-1 in Second-line of Advanced Non-small Cell Lung Cancer
NCT ID:
NCT05529355
Condition:
Carcinoma, Non-Small-Cell Lung
Conditions: Official terms:
Carcinoma, Non-Small-Cell Lung
Tegafur
Endostar protein
Endostatins
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Unknown status
Study design:
Allocation:
Non-Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Envafolimab plus Endostar and S-1
Description:
Immunotherapy combined with chemotherapy and anti VEGFR therapy
Arm group label:
Envafolimab plus Endostar and S-1
Other name:
Envafolimab combined with Recombinant Human Endostatin Injection/Tegafur,Gimeracil and Oteracil Porassium Capsules
Intervention type:
Drug
Intervention name:
Envafolimab plus Endostar
Description:
Immunotherapy combined with anti VEGFR therapy
Arm group label:
Envafolimab plus Endostar
Other name:
Envafolimab combined with Recombinant Human Endostatin Injection
Intervention type:
Drug
Intervention name:
Envafolimab plus S-1
Description:
Immunotherapy combined with chemotherapy
Arm group label:
Envafolimab plus S-1
Other name:
Envafolimab combined with Tegafur,Gimeracil and Oteracil Porassium Capsules
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).
Criteria for eligibility:
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:
-
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Start date:
September 18, 2022
Completion date:
September 18, 2023
Lead sponsor:
Agency:
Anhui Chest Hospital
Agency class:
Other
Source:
Anhui Chest Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05529355
