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NCT05058560 | COMPLETED | NSCLC

Tislelizumab in Addition to BACE in Patients with NSCLC
Sponsor:

The First Affiliated Hospital of Zhengzhou University

Information provided by (Responsible Party):

X U-d u-press

Brief 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.

Condition or disease

NSCLC

Intervention/treatment

Tislelizumab

Phase

PHASE2

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.

Study Type : INTERVENTIONAL
Estimated Enrollment : 30 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : Tislelizumab in Addition to Bronchial Arterial Chemoembolization in Patients with Non-Small-Cell Lung Cancer -- a Single-arm Phase II Trial
Actual Study Start Date : 2021-12-01
Estimated Primary Completion Date : 2025-02-04
Estimated Study Completion Date : 2025-02-15

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 75 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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
Tislelizumab in Addition to BACE in Patients with NSCLC

Location Details

NCT05058560

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How to Participate

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Locations

Not yet recruiting

China, Henna

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henna, China, 450000