NCT05058560

Tislelizumab in Addition to BACE in Patients with NSCLC

Tislelizumab in Addition to Bronchial Arterial Chemoembolization in Patients with Non-Small-Cell Lung Cancer -- a Single-arm Phase II Trial

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: The First Affiliated Hospital of Zhengzhou University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a single-arm phase II trial to determine the efficacy and safety of Tislelizumab in addition to bronchial arterial chemoembolization in stage III-Ⅳ NSCLC patients who failed, refused or ineligible to receive standard treatments.

Detailed description

Bronchial artery chemoembolization (BACE) is a technique of drug delivery and embolization performed via injecting anti-tumor drugs with drug carriers and implanting the embolization agents into the tumor feeding artery, promoting the clinical outcomes of patients and providing a palliative treatment option for patients with NSCLC. while the short-term effect of BACE is good, it is easy to relapse and metastasize. The rapid development of immunotherapy checkpoint inhibitors represented by PD-1/L1 monoclonal antibody has changed the treatment pattern of NSCLC. The publication of early research data repeatedly verified the long-term survival benefit characteristics of PD-1/L1 in NSCLC. Tislelizumab is an investigational humanized IgG4 monoclonal antibody with high affinity and binding specificity for PD-1. Tislelizumab was engineered to minimize binding to FcγR on macrophages in order to limit antibody-dependent phagocytosis, a potential mechanism of resistance to anti-PD-1 therapy. Tislelizumab in combination with platinum-based chemotherapy as first-line treatment for advanced SCLC and NSCLC, including nsq-NSCLC, resulted in robust responses in a phase 2 study (BGB-A317-206 \[NCT03432598\]), In phase 3 study, addition of tislelizumab to chemotherapy resulted in significantly improved progression-free survival (PFS) compared with chemotherapy alone in patients with stage IIIB or IV squamous NSCLC (RATIONALE 307; BGB-A317-307 \[NCT03594747\]) and nsq-NSCLC (RATIONALE 304; BGB-A317-304 \[NCT03663205\]). Second-and third-line tislelizumab monotherapy prolonged OS in the ITT and PD-L1 ≥ 25% populations vs docetaxel in patients with advanced NSCLC(RATIONALE 303; BGB-A317-303 \[NCT03358875\]). China NMPA have approved for tislelizumab + chemotherapy for 1L NSCLC. This trial is designed to determine the efficacy and safety of Tislelizumab in addition to Bronchial Arterial Chemoembolization in stage III-Ⅳ NSCLC patients who failed, refused or ineligible to receive standard treatments.

Conditions

• NSCLC

Interventions

Type	Name	Description
DRUG	Tislelizumab	tislelizumab, 200 mg IV Q3W, up to one year.

Timeline

• Start date: 2021-12-01
• Primary completion: 2025-02-04
• Completion: 2025-02-15
• First posted: 2021-09-27
• Last updated: 2025-03-13

Locations

1 site across 1 country: China