Tislelizumab Plus Chemotherapy and BACE for Unresectable NSCLC

Korábbi kezelés

• Prior local therapy for NSCLC, including radiotherapy or interventional therapy
• Major surgery requiring general anesthesia within 4 weeks before first dose

Más betegség

• History of another malignancy within the past 5 years
• Active autoimmune disease or history of autoimmune disease requiring systemic treatment
• Known allergy to any study drug or excipient
• Interstitial lung disease, non-infectious pneumonitis, chronic obstructive pulmonary disease, or other uncontrolled systemic diseases judged to interfere with study treatment
• Severe chronic or active infection requiring systemic antibacterial, antifungal, or antiviral therapy, including active tuberculosis
• Any medical condition, alcohol or drug abuse, or dependence that may interfere with study treatment, interpretation of results, or increase treatment risk
• Psychiatric illness or history of psychotropic drug abuse that may compromise study participation
• Any condition judged by the investigator to make the patient unsuitable for the study

Laborértékek

• Known positive driver genomic alterations, including EGFR mutations, ALK rearrangements, ROS1 rearrangements, and MET exon 14 skipping alterations

Egyéb

• Distant organ metastasis
• Participation in another interventional therapeutic clinical study

• Age 18 to 80 years
• Histologically or cytologically confirmed non-small cell lung cancer (NSCLC)
• Newly diagnosed, previously untreated stage IIIA-IIIB NSCLC according to the 9th edition TNM staging system
• Initially unresectable disease as determined by multidisciplinary team (MDT) assessment
• At least 1 measurable intrapulmonary lesion according to RECIST version 1.1
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
• Forced expiratory volume in the first second (FEV1) \> 1.0 L and \> 40% of predicted normal value
• Estimated life expectancy of at least 3 months
• Adequate organ function
• Willingness to provide tumor tissue for pathology, molecular testing, and PD-L1 assessment before enrollment
• Women of childbearing potential must have a negative pregnancy test within 72 hours before the first dose and agree to use effective contraception during the study and for 3 months after the last dose of tislelizumab
• Men with partners of childbearing potential must agree to use effective contraception during the study and for 3 months after the last dose of tislelizumab
• Ability to understand and willingness to sign a written informed consent form