Unresectable Stage III Non-Small Cell Lung Squamous Cell Carcinoma
Conditions
Interventions
Treatment Group:Trilaciclib Combined with Concurrent Chemoradiotherapy
Sponsors
West China Hospital of Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age >=18 years old and = 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; 6.ECOG PS score 0-1; 7. Expected survival time >=3 months; 8. Use of reliable contraception from the time of informed consent until 3 months after the last dose, all women of childbearing potential must have a negative serum pregnancy test during screening, and lactating women must have no plans to breastfeed from the start of the drug until 3 months after the last dose; 9. Understand and sign the informed consent;
Exclusion criteria
Exclusion criteria: 1.Patients with any of the following conditions: Known HIV infection, active hepatitis B (defined as HBV DNA positive) or hepatitis C (HCV RNA positive);Interstitial lung disease/pulmonary inflammation;Active or suspected autoimmune disease requiring systemic treatment within the past 2 years; 2.Uncontrolled ischemic heart disease or clinically significant congestive heart failure (NYHA Class III or IV); 3.History of stroke or cerebrovascular events within 6 months prior to enrollment; 4.QTcF interval > 480 msec at screening, or > 500 msec for patients with a ventricular pacemaker; 5.Prior history of hematopoietic stem cell or bone marrow transplantation; 6.Allergy to the investigational drug or any of its components; 7.Any other condition deemed by the investigator to be unsuitable for participation in this study;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The incidence of grade >=3 neutropenia during the treatment period; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective response rate of tumors;Myeloprotection;Duration of relief;Overall survival;Progression-free survival;Safety;Disease control rate; | — |
Countries
China
Contacts
Public ContactLi Yan
West China Hospital of Sichuan University
Outcome results
None listed