Advanced Driver Gene-negative Non-squamous Non-Small Cell Lung Cancer
Conditions
Interventions
Experimental Group:Trilaciclib: 240 mg/m2, administered as a 30-minute intravenous infusion completed within 4 hours prior to chemotherapy.
Sintilimab: 200 mg, administered every 3 weeks (Q3W).
Pemetr
Control Group:Sintilimab: 200 mg, administered every 3 weeks (Q3W).
Pemetrexed: 500 mg/m2, administered every 3 weeks (Q3W).
Carboplatin: AUC 5 (maximum dose 750 mg), administered every 3 weeks (Q3W).
Sponsors
Shengjing Hospital of China Medical University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Inclusion Criteria: Patients must meet all of the following criteria to be eligible for enrollment in this study: 1. The subject voluntarily participates, provides signed informed consent, and is able to comply with the study procedures. 2. Age >=18 years at the time of enrollment, male or female. 3. Histologically or cytologically confirmed, advanced (Stage IV) non-squamous NSCLC (according to the 8th edition of the Union for International Cancer Control and American Joint Committee on Cancer TNM staging system for lung cancer). 4. Genetic testing report confirms the absence of known actionable driver gene mutations (reports from local laboratories are acceptable, provided a well-validated assay that has passed external quality assessment or is approved by the NMPA is used). 5. No prior systemic anti-tumor therapy for advanced non-squamous NSCLC (patients who have previously received adjuvant chemotherapy, neoadjuvant chemotherapy, or chemoradiotherapy are eligible if the diagnosis of advanced disease is made >12 months after the completion of the last treatment). 6. Presence of at least one measurable lesion according to RECIST 1.1: For non-nodal lesions, at least one lesion with a longest diameter =1.0 cm; for nodal lesions, at least one lesion with a short-axis diameter >=1.5 cm, as measured by computed tomography/magnetic resonance imaging (CT/MRI). If there is only one target lesion and it is non-nodal, its longest diameter must be >=1.5 cm. 7. Laboratory tests meeting the following criteria within the specified timeframe: (1)Hemoglobin>= 90 g/L (2)Absolute neutrophil count >= 1.5 × 10^9/L (3)Platelet count >= 100 × 10^9/L (4) Serum creatinine = 60 mL/min (calculated using the Cockcroft-Gault formula) (5)Total bilirubin = 30 g/L 8. ECOG performance status score of 0 or 1. 9. For women of childbearing potential: a negative serum pregnancy test result during screening and agreement to use reliable contraception from signing the informed consent form until 3 months after the last dose of study drug.
Exclusion criteria
Exclusion criteria: Exclusion Criteria: Subjects meeting any of the following criteria will be excluded from the study: 1. Refusal to sign the informed consent form or to undergo follow-up. 2. Histological or cytological confirmation of small cell carcinoma component or a predominantly squamous cell carcinoma component. 3. Genetic testing report confirming the presence of a known actionable driver gene mutation (reports from local laboratories are acceptable, provided a well-validated assay that has passed external quality assessment or is approved by the NMPA is used). 4. Known hypersensitivity to trilaciclib or any of its excipients. 5. Administration of hematopoietic growth factors, blood transfusion, or platelet transfusion within one week prior to the screening hematological tests. 6. History of any active autoimmune disease or autoimmune disorder. 7. Systemic use of corticosteroids (>10 mg prednisone daily or equivalent) or other immunosuppressive medications (e.g., cyclophosphamide, azathioprine, methotrexate, thalidomide, TNF-a inhibitors) within 2 weeks prior to the first dose. 8. Active or refractory infection requiring ongoing anti-infective therapy. 9. Significant cardiovascular impairment (e.g., history of congestive heart failure greater than New York Heart Association [NYHA] Class II), unstable angina or myocardial infarction within the past 6 months, or significant cardiac arrhythmia. QTcF interval >480 msec at screening (or >500 msec for patients with ventricular pacemakers). 10. History of stroke or cerebrovascular event within 6 months prior to enrollment. 11. Recipient of an allogeneic organ transplant requiring ongoing immunosuppressive therapy. 12. Known positive serology for human immunodeficiency virus (HIV). 13. Uncontrolled active hepatitis B (defined as HBsAg positive with HBV DNA levels above the upper limit of normal [ULN] of the central laboratory at screening; subjects with HBV DNA 90%), such as adequately treated carcinoma in situ of the cervix, basal cell or squamous cell skin cancer, localized prostate cancer treated with curative intent, or ductal carcinoma in situ of the breast treated with curative intent. 15. Anticipated requirement for any other form of anti-tumor therapy during the study period. 16. Use of Chinese herbal medicines with labeled anti-tumor indications or immunomodulatory drugs within 2 weeks prior to the first dose. 17. Administration of any live vaccine within 30 days prior to the first dose of study treatment. 18. Any medical condition that, in the investigator's judgment, renders the subject unsuitable for study participation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of grade >=3 neutropenia during chemotherapy treatment; | — |
Secondary
| Measure | Time frame |
|---|---|
| Duration of grade >=3 neutropenia during chemotherapy treatment;Incidence of grade >=3 thrombocytopenia;Usage rate of recombinant human interleukin-11 (rhIL-11) and/or thrombopoietin (TPO);Incidence of platelet transfusion;Incidence of grade 3 or 4 anemia during chemotherapy treatment;Usage rate of erythropoiesis-stimulating agents (ESA);Incidence of red blood cell transfusion (from Week 5 onwards);Usage rate of granulocyte colony-stimulating factor (G-CSF);Objective Response Rate;Disease Control Rate;Progression Free Survival ;Overall Survival;Incidence of adverse events (AEs) and serious adverse events (SAEs) as assessed by NCI CTCAE, Version 5.0.; | — |
Countries
China
Contacts
Public ContactYu Li
Shengjing Hospital of China Medical University
Outcome results
None listed