A Study of Tislelizumab (BGB-A317) Plus Chemoradiotherapy Followed by Tislelizumab Monotherapy in Newly Diagnosed, Stage III Subjects With Locally Advanced, Unresectable Non-small Cell Lung Cancer
Condition: Carcinoma, Non-Small-Cell Lung
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Intervention: Tislelizumab; Concurrent chemoradiotherapy (cCRT); Placebo
Intervention description: PD-1 inhibitor (monoclonal antibody against PD-1); Chemotherapy options include carboplatin/paclitaxel and cisplatin/etoposide per standard of care. Radiotherapy will also be given concurrently with chemotherapy.; Placebo
Intervention MeSH terms: Tislelizumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 1.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Locally Advanced, Unresectable Non-Small Cell Lung Cancer; Non-Small Cell Lung Cancer; NSCLC; Randomized; BGB-A317; Tislelizumab; PD-1

Summary:

      This is a Phase 3, randomized, double-blind, placebo-controlled multicenter global study
      designed to compare the efficacy and safety of tislelizumab in combination with concurrent
      chemoradiotherapy (cCRT) followed by tislelizumab monotherapy versus cCRT alone, and
      tislelizumab given sequentially after cCRT versus cCRT alone, in newly diagnosed stage III
      subjects with locally advanced, unresectable non-small cell lung cancer (NSCLC). The primary
      endpoint is centrally-assessed progression free survival (PFS) in the intent-to-treat (ITT)
      population. .
    

Eligibility criteria:

        Inclusion Criteria:

          1. Newly diagnosed, histologically confirmed, locally advanced, stage III unresectable
             non small cell lung cancer (NSCLC).

             Staging will be confirmed at screening by positron emission tomography-computed
             tomography (PET/CT) and brain imaging by magnetic resonance imaging (MRI) or computed
             tomography (CT) with contrast.

          2. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1.

          3. Epidermal growth factor receptor (EGFR) mutation and anaplastic lymphoma kinase (ALK)
             gene translocation status available prior to randomization.

          4. Provision of fresh or archival tumor tissue or discussion with Sponsor.

          5. Adequate hematologic and end-organ function.

        Exclusion Criteria:

          1. Prior therapies including those targeting PD-1 or PD-L1 or chemotherapy, radiation,
             targeted therapy, biologic therapy, immunotherapy or investigational agent used to
             control non-small cell lung cancer (NSCLC).

          2. History of severe hypersensitivity reactions to other monoclonal antibodies or any
             contraindication to the planned chemotherapy regimen.

          3. History of, or ongoing, interstitial lung disease; pneumonitis requiring steroids; or
             clinically significant pericardial effusion.

          4. Any active malignancy less than or equal to 2 years before randomization, with the
             exception of non-small cell lung cancer (NSCLC) and any locally recurring cancer that
             has been treated curatively.

          5. Severe chronic or active infections including those requiring systemic antibacterial,
             antifungal or antiviral therapy; known human immunodeficiency virus (HIV) infection;
             untreated chronic hepatitis B or chronic hepatitis B virus carries or active hepatitis
             C; or active autoimmune disease.

          6. Prior allogeneic stem cell transplantation or organ transplantation.

          7. Significant cardiovascular disease or other condition which places the patient at
             risk.