Tislelizumab Plus Chemotherapy and BACE for Unresectable NSCLC

The goal of this phase 2 trial is to evaluate the efficacy and safety of tislelizumab combined with intravenous chemotherapy and bronchial artery chemoembolization (BACE) as conversion therapy for patients with initially unresectable stage IIIA-IIIB non-small cell lung cancer (NSCLC). The main questions it aims to answer are: * What is the 1-year event-free survival (EFS) rate with this treatment? * Can this treatment improve tumor response and the chance of curative-intent resection? * What adverse events occur during treatment? Participants will receive tislelizumab, intravenous chemotherapy, and BACE for up to 4 cycles. Tumor response and resectability will be evaluated by imaging and multidisciplinary team (MDT) assessment every 2 cycles. Participants who become resectable may undergo surgery followed by postoperative treatment per protocol. Participants who remain unresectable after 4 cycles will receive guideline-recommended chemoradiotherapy followed by tislelizumab consolidation. Regular follow-up will be performed for efficacy and safety assessment.

Sex

All

Minimum age

18 Years

Maximum age

80 Years

Inclusion Criteria:

* 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

Exclusion Criteria:

* Prior local therapy for NSCLC, including radiotherapy or interventional therapy
* Known positive driver genomic alterations, including EGFR mutations, ALK rearrangements, ROS1 rearrangements, and MET exon 14 skipping alterations
* Distant organ metastasis
* 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
* Major surgery requiring general anesthesia within 4 weeks before first dose
* Any medical condition, alcohol or drug abuse, or dependence that may interfere with study treatment, interpretation of results, or increase treatment risk
* Participation in another interventional therapeutic clinical study
* 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

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