Tislelizumab in Addition to BACE in Patients With NSCLC
Study Details
Study Description
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 | Intervention/Treatment | Phase |
|---|---|---|
| Phase 2 |
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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: BACE+Tislelizumab BACE was performed on the first day of the first cycle, and the first 200 mg of tislelizumab was given 3-5 days later. |
Drug: Tislelizumab
tislelizumab, 200 mg IV Q3W, up to one year.
Other Names:
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Outcome Measures
Primary Outcome Measures
- Progression-free survival (PFS) [Time from the first BACE treatment to either radiological progression or death or up to 12 months]
Time from the first BACE treatment to either radiological progression or death
Secondary Outcome Measures
- Objective response rate (ORR) [2, 4, 6 months after the first BACE treatment, up to death or 12 months]
Proportion of patients with reduction in stable in tumor burden of a predefined amount
- Disease control rate (DCR) [2, 4, 6 months after the first BACE treatment, up to death or 12 months]
Proportion of patients with reduction or keeping in stable in tumor burden of a predefined amount
- Overall survival (OS) [1 years or more]
Time from the first BACE treatment to death from any cause or the end of the study
- Quality of life score (EORTC, QLQ-30) [Every two months after treatment when the patient was assessed complete response; every month after treatment when assessed partial response, stable disease or progressive disease; up to progressive disease after the second treatment or within 12 months]
Changes of quality of life score; using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-30) Scores
Eligibility Criteria
Criteria
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)；
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Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1
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Adequate hematologic and end-organ function.
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Expected life span > 3 months.
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Be able to provide fresh or archival tumor tissues for PD-L1 expression in tumor cells
Exclusion Criteria:
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Prior therapies of docetaxel or treatment targeting PD-1, PD-L1 or CTLA-4.
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Prior therapies of interventional therapy (I seeds implantation, Ablation, BACE).
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Harboring EGFR sensitizing mutation or ALK gene translocation
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History of interstitial lung disease, non-infectious pneumonitis or participants with significantly impaired pulmonary function, or who require supplemental oxygen at baseline.
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With uncontrollable pleural effusion, pericardial effusion, or clinically significant ascites requiring interventional treatment.
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Symptomatic central nervous system metastasis
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Known HIV infection, participants with untreated chronic hepatitis B, active vaccination treatment.
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Prior allogeneic stem cell transplantation or organ transplantation
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Active autoimmune diseases or history of autoimmune diseases that may relapse.
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With conditions requiring systemic treatment with either corticosteroids (>10 mg daily prednisone or equivalent) or other immunosuppressive medications
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Known to be hypersensitive to contrast agent;
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Pregnant or breastfeeding women;
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Other protocol defined Inclusion/Exclusion criteria may apply
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | The First Affiliated Hospital of Zhengzhou University | Zhengzhou | Hennan | China | 450000 |
Sponsors and Collaborators
- The First Affiliated Hospital of Zhengzhou University
Investigators
- Principal Investigator: Xuhua Duan, Zhengzhou University - First Affiliated Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 20210831