Tislelizumab in Addition to BACE in Patients With NSCLC

• Status: Not yet recruiting
• Trial end date: 2023-12-15
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The First Affiliated Hospital of Zhengzhou University
• Collaborator: BeiGene

Criteria

Inclusion Criteria:

1. Patient age between 18 and 75

2. Signed Informed Consent Form.

3. Confirmed TNM stage is III-Ⅳ of NSCLC ，and failed, refused or assessed ineligible to receive conventional treatments (surgery, chemoradiotherapy, Chemotherapy)；

4. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1

5. Adequate hematologic and end-organ function.

6. Expected life span > 3 months.

7. Be able to provide fresh or archival tumor tissues for PD-L1 expression in tumor cells

Exclusion Criteria:

1. Prior therapies of docetaxel or treatment targeting PD-1, PD-L1 or CTLA-4.

2. Prior therapies of interventional therapy (I seeds implantation, Ablation, BACE).

3. Harboring EGFR sensitizing mutation or ALK gene translocation

4. History of interstitial lung disease, non-infectious pneumonitis or participants with significantly impaired pulmonary function, or who require supplemental oxygen at baseline.

5. With uncontrollable pleural effusion, pericardial effusion, or clinically significant ascites requiring interventional treatment.

6. Symptomatic central nervous system metastasis

7. Known HIV infection, participants with untreated chronic hepatitis B, active vaccination treatment.

8. Prior allogeneic stem cell transplantation or organ transplantation

9. Active autoimmune diseases or history of autoimmune diseases that may relapse.

10. With conditions requiring systemic treatment with either corticosteroids (>10 mg daily prednisone or equivalent) or other immunosuppressive medications

11. Known to be hypersensitive to contrast agent;

12. Pregnant or breastfeeding women;

13. Other protocol defined Inclusion/Exclusion criteria may apply