non-small cell lung cancer
Conditions
Interventions
Trilacil group:Administer tricacil before chemotherapy
Sponsors
Henan Provincial Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1: Age >= 18 years old, male or female; 2: Patients with histopathologically confirmed, unresectable locally advanced and advanced ((IIIB, IIIC, IV)) NSCLC (no local symptoms (with or without Brain metastasis)) There is at least one measurable lesion meeting RECIST1.1 criteria3: Need to receive chemotherapy treatment (first-line chemotherapy treatment uses platinum + pemetrexed/docetaxel/nab-paclitaxel/paclitaxel; second-line chemotherapy treatment: choose the above first-line chemotherapy treatment without using chemotherapy drugs; (Note: If the first-line chemotherapy treatment is not combined with Immunotherapy, patients who subsequently add immunotherapy will not be counted as additional lines. The number of treatment lines in this trial is limited to the number of chemotherapy treatment lines) 4: Laboratory tests meet the following standards: Hemoglobin >= 100 g/L (female), 110g/L (male) neutrophil count >= 2×10^9/L platelet count >= 100×10^9/L; creatinine = 60 mL/min (Cockcroft-Gault formula); Total bilirubin = 30 g/L; 5: ECOG PS score 0-1 points; 6: Women: All women with potential childbearing potential must have a negative serum pregnancy test result during the screening period, and must take reliable contraceptive measures from signing the informed consent form to 3 months after the last dose; 7: Understand and sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1: Diagnosed with other malignant diseases other than NSCLC within 5 years before the first dose (excluding radically cured cutaneous basal cell carcinoma, cutaneous squamous cell carcinoma, and/or radically resected carcinoma in situ); 2: Uncontrolled Ischemic heart disease or clinically significant congestive heart failure (NYHA class III or IV); 3: Stroke or cardiovascular and cerebrovascular events within 6 months before enrollment; 4: QTcF at screening Interval>480msec, for patients with ventricular pacemaker implantation, QTcF>500msec; 5: Have received hematopoietic stem cell or bone marrow transplantation in the past; 6: Allergic to the study drug or its ingredients; 7: The researcher believes that it is not suitable to participate in this study researched.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of grade =3 neutropenia during chemotherapy treatment;Safety and quality of life;Anti-tumor efficacy; | — |
Secondary
| Measure | Time frame |
|---|---|
| Bone Marrow Protection; | — |
Countries
China
Contacts
Public ContactZhao Yanqiu
Henan Provincial Cancer Hospital
Outcome results
None listed