NSCLC
Conditions
Interventions
Single-arm:Patients with advanced NSCLC diagnosed by pathology were screened after signing informed consent, and eligible subjects were treated with trilaciclib before receiving platinum-containing do
Transfusion of blood products and replenishment of hematopoietic raw materials
The use of hematopoietic growth factors
Systemic antibiotic use
The QLQ-C30 scale was scored. Tumor imaging was evaluated according to RECIST1.1.
Sponsors
Xinyang Central Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1) Age = 18 years old, male or female; 2) For patients with stage IV driver negative NSCLC who are scheduled to receive platinum-containing double-drug chemotherapy, 4 to 6 cycles of chemotherapy; Presence of at least one measurable lesion that meets RECIST1.1 criteria; 3) Laboratory tests meet the following standards: Hemoglobin = 100 g/L (female), 110g/L (male) neutrophil count = 2×109/L Platelet count =100×109/L; Creatinine = 15mg/L or creatinine clearance (CrCl) = 60 mL/min (Cockcroft-Gault formula); Total bilirubin = 1.5× upper limit of normal (ULN); ALT and AST = 3 × ULN or =5× ULN (for patients with liver metastases); Albumin = 30 g/L; 4) ECOG PS score 0-1; 5) Expected survival time = 3 months; 6) Women: All women with potential fertility must have a negative serum pregnancy test result during the screening period, and must take reliable contraceptive measures from the signing of informed consent until 3 months after the last dose; 7) Understand and sign the informed consent.
Exclusion criteria
Exclusion criteria: 1) Malignant diseases other than NSCLC diagnosed within 5 years prior to initial administration (excluding radical basal cell carcinoma of the skin, squamous epithelial carcinoma of the skin, and/or carcinoma in situ after radical resection); 2) uncontrolled ischemic heart disease or clinically significant congestive heart failure (NYHA Class III or IV); 3) Stroke or cardiovascular event within 6 months prior to enrollment 4) QTcF interval > 480msec during screening, and QTcF > 500msec for patients with implanted ventricular pacemakers 5) Have previously received hematopoietic stem cell or bone marrow transplantation 6) Allergic to the investigational drug or its ingredients; 7) Those that the researchers think are not suitable to participate in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of neutropenia during chemotherapy= grade 3 ; | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of grade 4 neutropenia during chemotherapy;Incidence of grade 3 or 4 thrombocytopenia;Incidence of grade 3 or 4 anemia during chemotherapy treatment;Incidence of febrile neutropenia;Utilization rate of granulocyte colony-stimulating factor (G-CSF);Utilization rate of recombinant human interleukin-11 and/or thrombopoietin (TPO);overall response rate;disease control rate;Duration of Response;Safety and quality of life; | — |
Countries
China
Contacts
Public ContactZhan Zhixiang
Xinyang Central Hospital
Outcome results
None listed