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NCT07561983

PHASE2

Tislelizumab Plus Chemotherapy and BACE for Unresectable NSCLC

Sponsor: Sichuan Cancer Hospital and Research Institute

View on ClinicalTrials.gov

Summary

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.

Official title: Tislelizumab Combined With Intravenous Chemotherapy and Bronchial Artery Chemoembolization as Conversion Therapy for Unresectable Non-Small Cell Lung Cancer: A Multicenter, Single-Arm, Phase II Trial (BEACON-Lung)

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2026-05-01

Completion Date

2028-12-31

Last Updated

2026-05-01

Healthy Volunteers

Conditions

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

Interventions

DRUG

Tislelizumab

Tislelizumab 200 mg is administered intravenously on Day 0 of each 21-day cycle for up to 4 cycles. Postoperative or consolidation tislelizumab may be given according to protocol-defined treatment pathways.

DRUG

Intravenous Chemotherapy

Intravenous chemotherapy is administered on Day 1 of each 21-day cycle for up to 4 cycles. Patients with lung squamous cell carcinoma receive albumin-bound paclitaxel, and patients with lung adenocarcinoma receive pemetrexed. Carboplatin is administered intra-arterially during BACE in cycles with the procedure; if BACE is not performed in a given cycle, carboplatin is administered intravenously on the same day per protocol.

PROCEDURE

Bronchial Artery Chemoembolization (BACE)

BACE is performed on Day 1 of the first 21-day treatment cycle using intra-arterial carboplatin infusion followed by embolization with 300-500 μm blank microspheres. Subsequent BACE procedures are performed on demand, based on tumor response on contrast-enhanced chest CT and multidisciplinary team (MDT) evaluation. The total number of BACE procedures ranges from 1 to 4.

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

Locations (1)

Sichuan Cancer Hospital and Research Institute

Chengdu, Sichuan, China