Initial unresectable stage III non-small cell lung cancer
Conditions
Interventions
Treatment group:? Induction therapy: Patients meeting the inclusion criteria will receive Tislelizumab in combination with cisplatin/carboplatin and albumin-paclitaxel induction therapy every 3 weeks
Sponsors
West China Hospital of Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1: Able to provide written informed consent (ICF), and able to understand and agree to adhere to study requirements and evaluation schedules. 2: Male or female aged 18-70 at the time of signing the ICF. 3: Histologically confirmed Stage III initial unresectable squamous or non-squamous non-small cell lung cancer (AJCC Stage 8th edition) - Unresectable stage III NSCLC mainly refers to imaging or lymph node pathological evidence: • Lesions invade vital organs (including the diaphragm, mediastinum, great blood vessels, trachea, recurrent laryngeal nerve, esophagus, or satellite nodules in different pulmonary lobes on the same side of the primary tumor, leading to investigator's determination that R0 resection cannot be performed) (IIIA: T4N0-1); • Multiple metastases of ipsilateral mediastinal lymph nodes fused into masses or multi-station metastases (IIIA: T1-2N2 or IIIB: T3-4N2); • Metastases in the hilar, mediastinal lymph nodes, or in the scalene muscle or supraclavicular lymph nodes (IIIB: T1-2N3, IIIC: T3-4N3); ? Determination of N2/N3 lymph node involvement: PET-CT was used to confirm lymph node status. In cases where PET-CT is insufficient to determine lymph node staging (for example, lymph node diameter 1.5L/S, in line with the requirements for radical surgery and chemoradiotherapy. 9: Fertile patients must be willing to use highly effective contraception during the study period and for 120 days after the last dose of Tislelizumab.
Exclusion criteria
Exclusion criteria: 1: Prior treatment for current lung cancer, including radiation therapy and all systemic antitumor agents, including chemotherapy, immunotherapy, targeted therapy, or antiangiogenic therapy. 2: Previous chest radiation therapy, including lung, esophageal, mediastinal, or breast cancer. 3: Patients with large cell neuroendocrine carcinoma (LCNEC) components, or mixed NSCLC. 4: Patients with known EGFR gene mutation, ALK rearrangement, ROS-1 fusion, RET fusion, HER-2 mutation, MET mutation, and non-squamous NSCLC patients with unknown driver gene status. 5: Patients received other approved systemic immunomodulators (including, but not limited to, interferon, interleukin 2, tumor necrosis factor, thymus pentapeptide, and thymofasin) within 4 weeks prior to initial administration. 6: Any Chinese herbs used for cancer tratment within 14 days prior to the first administration of study drug. 7: Had received live or attenuated vaccine within 4 weeks prior to enrollment, or expected to require live or attenuated vaccine during the study period or within 5 months after the last administration of Tislelizumab. 8: Any condition requiring systemic treatment with corticosteroids (prednisone or equivalent >10 mg/ day) or other immunosuppressive drugs within 14 days prior to the first administration of study drug, and may have impacts on the study treatment as assessed by the investigator. 9: Active autoimmune diseases requiring systemic treatment, and may have impacts on the study treatment as assessed by the investigator. 10: Patients with interstitial lung disease, non-infectious pneumonia, or other diseases that have not been controlled, including diabetes, pulmonary fibrosis, acute lung disease, etc., and may have impacts on the study treatment as assessed by the investigator. 11: Patients with a history of major diseases or clinical manifestations that may affect organ system function and are considered to have an impact on the study treatment as assessed by the investigator. 12: Serious chronic or active infections (including tuberculosis infection) requiring systemic antimicrobial, antifungal or antiviral treatment =14 days before the first administration of study drug. 13: Known history of human immunodeficiency virus (HIV) infection. 14: Patients with untreated chronic hepatitis B or chronic hepatitis B virus carriers with HBV DNA=500 IU/mL (2500 copies /mL), patients with active hepatitis C. 15: Previous allogeneic stem cell transplantation or organ transplant. 16: The presence of any of the following cardiovascular risk factors: a. The presence of cardiogenic chest pain =28 days before the first administration of study drug; b. The presence of symptomatic pulmonary embolism =28 days before the first administration of study drug; c. Any history of acute myocardial infarction =6 months before the first administration of study drug; d. History of any New York Heart Association (NYHA) grade III or IV heart failure =6 months prior to initial administration of study drug; e. Any ventricular arrhythmia event with severity = grade 2 =6 months before the first administration of study drug; f. History of any cerebrovascular accident =6 months before the first administration of study drug; g. Corrected QT interval (QTc) > 450 ms (male) or > 480ms (female); h. Left ventricular ejection fraction (LVEF) = lower limit of normal (LLN) as assessed by echocardiography (ECHO); i. Poorly controlled hypertension: systolic blood pressure =160 mmHg or diastolic
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1-year event-free survival rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival;1 year /2 years /3 years OS rate;Event-free survival (EFS);2 /3 year EFS rate;Time to Distant Metastasis (TTDM);Objective response rate (ORR);Disease control rate (DCR);Clinical down-staging rate;Surgical resection rate;R0 resection rate;Major pathological response (MPR) rate;Pathological complete response (pCR) rate;Time to Local Recurrence (TTLR);Pathological down-staging rate;Adverse Events (AE) ; | — |
Countries
China
Contacts
Public ContactGuowei Che
West China Hospital of Sichuan University
Outcome results
None listed