NSCLC
Conditions
Interventions
Experimental group: Eutidrone versus Cisplatin/Carboplatin combined with Envafolimab
Sponsors
The First Affiliated Hospital of University of Science and Technology of China (Anhui Provincial Cancer Hospital)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Sign the informed consent and promise to comply with the relevant requirements of this study. 2.Male or Female >18. 3.Histologically or cytologically confirmed non-small cell lung cancer (squamous cell carcinoma/adenocarcinoma is acceptable)according to the 8th AJCC staging criteria, stage IV or stage IIIB-IIIC inoperable for radical surgery or radiotherapy. 4.Tumor samples can be provided for subsequent relevant testing. 5.At least one measurable disease according to the response evaluation criteria in solid tumor (RECIST 1.1). 6.Eastern Cooperative Oncology Group (ECOG) performance status of = 2.5*10^9/L; Neutrophil count (ANC) >= 1.5*10^9/L; Platelet count (PLT) >= 75*10^9/L; Hemoglobin >= 8.0 g/dL; Patients could receive blood transfusions or erythropoietin to meet this criterion. 13.Liver and kidney function were basically normal within 1 week before enrollment (based on the normal values of the participating laboratory): Total bilirubin (TBIL) =60 ml/min 15.International normalized ratio (INR) and activated partial thromboplastin time (aPTT) = 12 weeks. 18.Patients must be able to participate in and adhere to treatment a
Exclusion criteria
Exclusion criteria: 1.NSCLC patients with EGFR gene sensitive mutation and ALK fusion gene positive; 2.Other malignant tumors (including primary brain or leptomeningeal related tumors) within the past 5 years, except cured basal cell carcinoma of the skin and carcinoma in situ of the cervix; 3. Previous anti-tumor therapy, including chemotherapy, radical radiotherapy, hormone therapy, biological therapy, immunotherapy or anti-tumor traditional Chinese medicine therapy, postoperative adjuvant therapy interval should be more than 6 months; 4.Had undergone major organ surgery (excluding needle biopsies) or major trauma within 4 weeks before the first dose of the study drug, or required elective surgery during the trial. 5. Central nervous system metastasis with clinical symptoms. 6. Lung radiation therapy exceeding 30 Gy within the first 6 months. 7. Symptomatic peripheral neuropathy was evaluated as CTCAE 5.0 grade >=2 . 8. Patients with severe adverse reactions after previous use of anti-microtubule drugs. 9. Known or suspected allergy to any study drug or excipient. 10.Previous adverse reactions of anti-tumor therapy have not recovered to CTCAE 5.0470ms; Acute coronary syndrome, congestive heart failure, aortic dissection, stroke, or other grade 3 or higher cardiovascular events occurred within 6 months before the first dose of dose; Clinically uncontrolled hypertension; High risk Cardiac disease judged by other investigators ; 15.Patients with mental disorders or poor adherence. 16.Pregnant or lactating women. 17.Other non-malignant systemic diseases (kidney, liver, etc.) that were treated by any treatment regimen or prevented follow-up were excluded. 18.Participation in another clinical trial or use of another investigational treatment. 19.Any other condition considered by the investigator to be unsuitable for participation in the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall Objective response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Time to response;Progression-free survival;Duration of response;Over Survival; | — |
Countries
hina
Contacts
Public ContactYueyin Pan
The First Affiliated Hospital of University of Science and Technology of China (Anhui Provincial Cancer Hospital)
Outcome results
None listed