non-small cell lung cancer
Conditions
Interventions
Experimental group:Trilaciclib +PD-1 monoclonal antibody + pemetrexed/paclitaxel protein-bound + carboplatin
Control group:PD-1 monoclonal antibody + pemetrexed/paclitaxel protein-bound + carboplatin
Sponsors
Liaoning Cancer Hospital & Institute
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. The subjects voluntarily participate, sign the informed consent, and comply with the research procedures; 2. Age >=18 years old at the time of enrollment, both male and female; 3. The histology and cytology confirmed late non-small cell lung cancer, drive gene mutation negative (such as EGFR, ALK, mutated BRAF, MET, ROS1, RET, KRAS G12C, etc.), for non squamous NSCLC subjects, must be able to provide always gene detection based on histology and cytology test report. For subjects with squamous NSCLC, if the previous genetic mutation status is unknown, corresponding testing is not required before enrollment and is considered negative. 5. Measurable lesions: For non-lymph nodes, the longest diameter of at least one lesion is >=1.0 cm, or for lymph nodes, the diameter of at least one lesion is >=1.5 cm, which can be continuously measured using computed tomography/CT/MRI according to RECIST1.1. If there is only one target lesion and it is a non-lymph node, its maximum diameter should be >=1.5 cm. 6. Laboratory tests meet the following standards: Hemoglobin >= 90 g/L Neutrophil count >= 1.5×10^9/L Platelet count >=100×10^9/L; Creatinine = 60 mL/min (Cockcroft-Gault formula); Total bilirubin = 30 g/L; 7. ECOG score 0-1; 8. 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;
Exclusion criteria
Exclusion criteria: 1. Refuse to sign the informed consent or refuse follow-up; 2. Drive gene mutation positive (such as EGFR, ALK, mutated BRAF, MET, ROS1, RET, etc.); 3. Receive hematopoietic growth factor, blood transfusion or platelet transfusion within one week before blood test during the screening period 4. Present with any active autoimmune disease or history of autoimmune disease; 5. Patients with systemic use of corticosteroids (> 10mg daily or equivalent of prednisone) or other immunosuppressive drugs (e.g. Cyclophosphamide, azathioprine, methotrexate, thalidomide, TNF-a inhibitors, etc.) within 2 weeks prior to initial administration; 6. Patients with active/refractory infections who require continuous anti-infective treatment; 7. Severe cardiovascular injury (greater than a New York Heart Association (NYHA) Class II history of congestive heart failure), unstable angina or myocardial infarction within the past 6 months, or severe arrhythmia. During screening, the QTcF interval was > 480msec, and for patients with implanted ventricular pacemakers, the QTcF was > 500msec 8. Stroke or cardiovascular and cerebrovascular events within 6 months before enrollment; 9. Subjects with allogeneic organ transplants requiring immunosuppressive therapy; 10. Known human immunodeficiency virus (HIV) positive subjects; 11. Uncontrolled active hepatitis B (defined as positive HBV surface antigen HBsAG test results during screening and HBV DNA test values higher than the upper limit of normal values in the laboratory of the research center; Participants with HBV DNA levels < 500 IU/mL within 28 days prior to randomization who have received local standard antiviral therapy for at least 4 weeks and are willing to continue antiviral therapy for the duration of the study may be enrolled); Subjects with active hepatitis C (defined as positive HCsAb test results for HCV surface antibodies and positive HCV RNA during screening); 12. Cervical carcinoma in situ, basal cell or squamous cell skin cancer, local prostate cancer after radical surgery, and ductal carcinoma in situ after radical surgery with other malignant tumors that have been present for =5 years in the past are not excluded; 13. Any other form of antitumor therapy is expected to be required during the study period; 14. Patients with spinal cord compression or symptomatic or progressive brain metastases were excluded. Patients who had completed treatment for brain metastases (radiation or surgery) with stable metastases and no associated symptoms (without drug control) within 4 weeks prior to first administration were enrolled. 15. Received proprietary Chinese medicines with anti-tumor indications or immunomodulatory drugs within 2 weeks before the first administration; 16. Live vaccination within 30 days prior to the first dose of investigational therapy; 17. The investigator considers the subject unfit for any medical condition for entry into the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-Free-Survival;safety; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective relief rate;disease control rate;Overall survival;The incidence of grade >= 3 neutropenia during chemotherapy treatment; The incidence of grade >= 3 thrombocytopenia during chemotherapy treatment; Incidence of grade 3 anemia during chemotherapy treatment; | — |
Countries
China
Contacts
Public ContactYuan Liang
Liaoning Cancer Hospital & Institute
Outcome results
None listed