Advanced squamous non-small cell lung cancer
Conditions
Interventions
Experimental group:Albumin paclitaxel or paclitaxel + carboplatin + tislelizumab + trilaciclib
Control group:Albumin paclitaxel or paclitaxel + carboplatin + tislelizumab
Sponsors
Dongguan People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age >= 18 years old, male or female; 2. Unresectable stage IIIB or IV squamous non-small cell lung cancer confirmed histologically or cytologically; 3. No previous systemic anti-tumor therapy for advanced tumors; 4. At least one measurable lesion according to RECIST1.1 criteria; 5. Patients with asymptomatic brain metastases or stable symptoms after treatment of brain metastases; 6. Laboratory tests meet the following standards: (1) Hemoglobin >=100 g/L (female), 110g/L (male) (2) neutrophil count >= 2×10^9/L (3) platelet count >=100×10^9/L; (4) creatinine = 60 mL/min (Cockcroft-Gault formula); (5) Total bilirubin =30 g/L; 7.ECOG PS score 0-1; 8. Expected survival time >= 3 months; 9. Women: all women of childbearing potential must have a negative serum pregnancy test during the screening period and must be using a reliable contraceptive method from the time of informed consent until 3 months after the last dose; 10. Understand and sign the informed consent.
Exclusion criteria
Exclusion criteria: 1. Patients with the following diseases: (1) known HIV infection, active hepatitis B (defined as HBV DNA positive) and hepatitis C (HCV RNA positive); (2) Interstitial lung disease/pulmonary inflammation; (3) active or suspected autoimmune disease requiring systemic treatment in the past 2 years; 2. Presence of epidermal growth factor receptor (EGFR) sensitive mutation or anaplastic lymphoma kinase (ALK) gene translocation; 3. Severe infection, active meningeal leukemia or uncontrolled and untreated brain metastases; 4. Receive a live attenuated vaccine within 4 weeks before enrollment or anticipate needing a live attenuated vaccine during the study; 5. Active autoimmune disease or a history of autoimmune disease; 6. Uncontrolled ischemic heart disease or clinically significant congestive heart failure (NYHA class III or IV); 7. Stroke or cardio-cerebrovascular event within 6 months before enrollment 8. QTcF interval > 480msec at screening or > 500msec for patients with implanted ventricular pacemakers 9. Prior hematopoietic stem-cell or bone marrow transplantation 10. Allergy to the study drug or its components; 11. Those who were deemed unsuitable for the study by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate; | — |
Countries
China
Contacts
Public ContactGuanming Jiang
Dongguan People's Hospital
Outcome results
None listed