Advanced Non-small Cell Lung Cancer
Conditions
Interventions
non-squamous non-small-cell lung cancer:Endostar (210mg, durative transfused for 120 hours) was administered every three weeks beginning on the first day of each treatment cycle. Carboplatin (AUC 5-6)
squamous cell cancer:Endostar (210mg, durative transfused for 120 hours) was administered every three weeks beginning on the first day of each treatment cycle. Carboplatin(AUC 5-6) or cisplatin (75 mg
Sponsors
The First Affiliated Hospital of Shandong First Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.Metastatic NSCLC is histologically or cytologically proven to be inoperable and cannot receive radical concurrent chemoradiotherapy. The conventional TNM stage was identified as stage IIIa-?b according to the International Association for the Study of Lung Cancer and the American Joint Committee on the Classification of Cancer 8th edition TNM Staging of Lung Cance. 2.The molecular testing for EGFR mutation,ALK and ROS1 is all negative. 3.Patients who had not previously received systemic radiotherapy and chemotherapy or who had relapsed for more than 6 months of follow-up after onset of adjuvant chemotherapy. 4.At least one measurable lesion as determined by RECIST criteria. 5.Male or female patients, age: 18-75 years of age. 6.Performance score 0-1 based on Eastern Cooperative Oncology Group (ECOG) test. 7.Expected survival period >= 12 weeks. 8.Serum absolute number of neutrophils >= 1.5 x 10^9/L, platelet >= 100 x 10^9/L,and hemoglobin >= 90g/L. 9.Serum bilirubin = 60 mL/min. 11.Patients who had previously undergone surgery have recovered for more than 4 weeks from the beginning of the project. 12.Women with an intact uterus must have a negative pregnancy test within 28 days prior to enrolement in the study (unless it was 24 months after amenorrhea). If the pregnancy test is more than 7 days prior to initial dosing, a urine pregnancy test is required for verification (within 7 days prior to initial dosing). 13.Sign the inform consent form with good compliance.
Exclusion criteria
Exclusion criteria: 1.Intolerance to platinum therapy or allergy to platinum drugs. 2.Allergic to recombinant human endostatin (endostar) and its any components. 3.Pregnancy or breastfeeding women or women who may be pregnant but are unwilling to take appropriate contraception. 4.Existing severe acute infections that are not under control; Or suppurative and chronic infections with delayed healing. 5.Pre-existing serious heart disease, including: congestive heart failure, uncontrolled high-risk arrhythmias, unstable angina pectoris, myocardial infarction, severe valvular heart disease, and refractory hypertension. 6.People suffering from uncontrollable neuropsychiatric diseases or mental disorders had poor compliance and were unable to cooperate and describe treatment responses; The conditions of patients with primary brain tumor or central nerve metastatic tumor were uncontrollable and the symptoms of cranial hypertension or neuropsychiatric were obvious. 7.People with tendency of bleeding. 8.Other conditions that the investigator considers to be inappropriate for the patient to participate in this trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression Free Survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall Survival;Objective Response Rate;Adverse Event; | — |
Countries
China
Contacts
Public ContactDegan Lu
The First Affiliated Hospital of Shandong First Medical University
Outcome results
None listed