Tislelizumab in Addition to BACE in Patients with NSCLC

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.

Inclusion criteria

• Patient age between 18 and 75
• Signed Informed Consent Form.
• Confirmed TNM stage is III-Ⅳ of NSCLC ，and failed, refused or assessed ineligible to receive conventional treatments (surgery, chemoradiotherapy, Chemotherapy)；
• Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1
• Adequate hematologic and end-organ function.
• Expected life span > 3 months.
• Be able to provide fresh or archival tumor tissues for PD-L1 expression in tumor cells

Exclusion criteria

• Prior therapies of docetaxel or treatment targeting PD-1, PD-L1 or CTLA-4.
• Prior therapies of interventional therapy (I seeds implantation, Ablation, BACE).
• Harboring EGFR sensitizing mutation or ALK gene translocation
• History of interstitial lung disease, non-infectious pneumonitis or participants with significantly impaired pulmonary function, or who require supplemental oxygen at baseline.
• With uncontrollable pleural effusion, pericardial effusion, or clinically significant ascites requiring interventional treatment.
• Symptomatic central nervous system metastasis
• Known HIV infection, participants with untreated chronic hepatitis B, active vaccination treatment.
• Prior allogeneic stem cell transplantation or organ transplantation
• Active autoimmune diseases or history of autoimmune diseases that may relapse.
• With conditions requiring systemic treatment with either corticosteroids (>10 mg daily prednisone or equivalent) or other immunosuppressive medications
• Known to be hypersensitive to contrast agent;
• Pregnant or breastfeeding women;
• Other protocol defined Inclusion/Exclusion criteria may apply