Non-small cell lung cancer
Conditions
Interventions
Experimental group:Tislelizumab + Chemotherapy Sequential Thoracic Consolidation Radiotherapy
Sponsors
Cancer Hospital Affiliated of Shandong First Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: Eligibility Criteria: Patients must meet all of the following inclusion criteria to be eligible for this study: 1.Age between 18-75 years, both male and female; 2.Histologically or cytologically confirmed advanced (Stage IV) non-small cell lung cancer (NSCLC) patients who have achieved complete response (CR) or partial response (PR) after completing 4-6 cycles of immunotherapy combined with chemotherapy; 3.ECOG performance status score of 0-1; 4.No prior systemic anti-tumor treatment for advanced NSCLC; 5.Patients who have previously received neoadjuvant/adjuvant chemotherapy, radical surgery, radiotherapy, or chemoradiotherapy for non-metastatic tumors with curative intent must have completed their last treatment at least 6 months prior to enrollment; 6.Patients must be free of EGFR mutations or known ALK gene translocations; 7.Women of childbearing potential must undergo a serum pregnancy test within 7 days prior to the first dose of the study drug, and the result must be negative. Both female patients of childbearing potential and male patients with partners of childbearing potential must agree to use contraception from the time of signing the informed consent form until 24 weeks after the last dose of the study drug; 8.Laboratory values prior to the first dose of the study drug must meet the following criteria: Complete blood count (no blood transfusion or use of hematopoietic stimulating agents within 14 days prior to screening): white blood cell count (WBC) >= 3.0 × 10^9/L; absolute neutrophil count (ANC) >= 1.5 × 10^9/L; platelet count (PLT) >= 100 × 10^9/L; hemoglobin (HGB) >= 9.0 g/dL; Liver function: for patients without liver metastasis, aspartate aminotransferase (AST) = 50 mL/minute (using Cockcroft/Gault formula); Coagulation function: international normalized ratio (INR) 1.5 × ULN, patients can be enrolled if there is no clinical or imaging evidence of pancreatitis); amylase 1.5 × ULN, patients can be enrolled if there is no clinical or imaging evidence of pancreatitis); alkaline phosphatase (ALP) <= 2.5 × ULN, for patients with liver or bone metastasis, ALP <= 5 × ULN; 9. Patients must voluntarily join the study, sign the informed consent form, have good compliance, and cooperate with follow-up.
Exclusion criteria
Exclusion criteria: Patients who met any of the following criteria had to be excluded from the study: 1. Diagnosis of NSCLC with EGFR sensitive mutations or ALK rearrangement. Approved systemic anticancer therapy, including hormonal therapy, within 28 days before initiation of study treatment. 3. Prior receipt of an EGFR or ALK inhibitor 4. Prior therapy targeting PD-1 or PD-L1. 5. Receipt of systemic immunomodulatory agents (including, but not limited to, interferon, interleukin-2, and tumor necrosis factor) 4 weeks before the first dose of study drug or within five half-life periods of the drug, whichever was longer (previous receipt of cancer vaccines was permitted). 6. Received Chinese herbal medicine or proprietary Chinese medicine for cancer control within 14 days before the first dose of study drug. 7. Patients with previous or current objective evidence of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonitis, drug-related pneumonia, severe impairment of pulmonary function, or uncontrolled systemic disease history, including diabetes, hypertension, acute lung disease, etc. 8. Clinically significant pericardial effusion. 9. Clinically uncontrolled pleural effusion or ascites requiring thoracentesis or abdominal incision for drainage within 2 weeks before the first dose of study drug. 10. Severe chronic or active infections, including tuberculosis infection, requiring systemic antimicrobial, antifungal, or antiviral therapy. 11. Active leptomeningeal disease or uncontrolled untreated brain metastases: 1) Patients with a history of asymptomatic CNS metastases at screening were eligible if all of the following conditions were met: Brain imaging at screening showed no evidence of immediate progression. In the presence of measurable disease outside the CNS, only supratentorial metastases were allowed. There was no current need for glucocorticoids for CNS disease. Stable doses of anticonvulsants were allowed. No stereotactic or whole brain radiation therapy was performed within 14 days prior to the first administration of the study drug. 2) Patients with new asymptomatic CNS metastases identified at screening must undergo radiotherapy and/or surgery for CNS metastases. After treatment, such patients were eligible if they met all other criteria, including those for patients with a history of brain metastases. 12. Any major surgery was performed 500 IU/mL, or active hepatitis C virus (HCV) infection should be excluded. Notes: Inactive hepatitis B surface antigen (HBsAg) carriers, treated patients with stable hepatitis B (HBV DNA < 500 IU/mL), and
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 12-Month Progression-Free Survival Rate (PFS12); | — |
Secondary
| Measure | Time frame |
|---|---|
| Investigator-Assessed Progression-Free Survival (PFS);Investigator-Assessed Overall Response Rate (ORR);Investigator-Assessed Duration of Response (DoR);Investigator-Assessed Disease Control Rate (DCR);1-Year Overall Survival Rate (OS Rate);Overall Survival (OS);Safety; | — |
Countries
China
Contacts
Public ContactXudong Hu
Cancer Hospital Affiliated of Shandong First Medical University
Outcome results
None listed