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
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. .
Checked against the public recordLast updated Jul 15, 2020 · Source: ClinicalTrials.gov
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 3
- Sponsor
- Celgene
- Interventions being studied
- Drug: Tislelizumab; Drug: Concurrent chemoradiotherapy (cCRT); Other: Placebo
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
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.
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- USC Norris Comprehensive Cancer CenterLos Angeles, California
- Cancer Specialists of North Florida - JacksonvilleJacksonville, Florida
- Bond Clinic, P.A.Winter Haven, Florida
- University of Chicago Medical CenterChicago, Illinois
- Fort Wayne Medical Oncology and HematologyFort Wayne, Indiana
- Appalachian Regional Healthcare, Inc.Hazard, Kentucky
- Norton Healthcare - Norton Cancer InstituteLouisville, Kentucky
- Center For Cancer and Blood DisordersBethesda, Maryland
- University of Mississippi Medical CenterJackson, Mississippi
- Dayton Physicians, LLCKettering, Ohio
- Mercy Health Youngstown Hospital, LLCYoungstown, Ohio
- Allegheny General HospitalPittsburgh, Pennsylvania
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Jul 15, 2020. Always confirm current availability with the study team.