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Tislelizumab in Addition to BACE in Patients With NSCLC

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT05058560
Recruitment Status : Not yet recruiting
First Posted : September 27, 2021
Last Update Posted : September 27, 2021
Information provided by (Responsible Party):
Xuhua Duan, The First Affiliated Hospital of Zhengzhou University

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
NSCLC Drug: Tislelizumab 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
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
Estimated Study Start Date : November 15, 2021
Estimated Primary Completion Date : June 15, 2023
Estimated Study Completion Date : December 15, 2023

Resource links provided by the National Library of Medicine

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 Name: Bronchial artery chemoembolization (BACE)

Primary Outcome Measures :
  1. Progression-free survival (PFS) [ Time Frame: 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 :
  1. Objective response rate (ORR) [ Time Frame: 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

  2. Disease control rate (DCR) [ Time Frame: 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

  3. Overall survival (OS) [ Time Frame: 1 years or more ]
    Time from the first BACE treatment to death from any cause or the end of the study

  4. Quality of life score (EORTC, QLQ-30) [ Time Frame: 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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
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Responsible Party: Xuhua Duan, Associate Professor, The First Affiliated Hospital of Zhengzhou University Identifier: NCT05058560    
Other Study ID Numbers: 20210831
First Posted: September 27, 2021    Key Record Dates
Last Update Posted: September 27, 2021
Last Verified: September 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Xuhua Duan, The First Affiliated Hospital of Zhengzhou University: