Tislelizumab Plus Chemotherapy and BACE for Unresectable NSCLC

Starting soon · Phase 2

Conditions studied: Unresectable Stage III Non-small Cell Lung Cancer, Tislelizumab, Chemotherapy, Chemoembolization, Therapeutic, Conversion Therapy

In brief

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.

Key facts

Study ID

NCT07561983

Run by

Sichuan Cancer Hospital and Research Institute

People needed

39

Starts

2026-05-01

Expected to finish

2028-12-31

Last updated by the study team

2026-05-01

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Sichuan Cancer Hospital and Research Institute — Chengdu, Sichuan, China

Full record on ClinicalTrials.gov

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