About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Tislelizumab
- Intravenous Chemotherapy
- Bronchial Artery Chemoembolization (BACE)
Treatment groups
Locations
1Sponsors and collaborators
Sichuan Cancer Hospital and Research Institute
Lead sponsor