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

Stopped early · Phase 3 · Has a placebo group

Conditions studied: Carcinoma, Non-Small-Cell Lung

In brief

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. .

Key facts

Study ID

NCT03745222

Run by

Celgene

People needed

1

Starts

2019-05-22

Expected to finish

2019-06-26

Last updated by the study team

2020-07-15

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.
• Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1.
• Epidermal growth factor receptor (EGFR) mutation and anaplastic lymphoma kinase (ALK) gene translocation status available prior to randomization.
• Provision of fresh or archival tumor tissue or discussion with Sponsor.
• Adequate hematologic and end-organ function.

You may not qualify if…

• 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).
• History of severe hypersensitivity reactions to other monoclonal antibodies or any contraindication to the planned chemotherapy regimen.
• History of, or ongoing, interstitial lung disease; pneumonitis requiring steroids; or clinically significant pericardial effusion.
• 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.
• 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.
• Prior allogeneic stem cell transplantation or organ transplantation.
• Significant cardiovascular disease or other condition which places the patient at risk.

Where it is running

• Cancer Specialists of North Florida - Jacksonville — Jacksonville, Florida, United States
• Bond Clinic, P.A. — Winter Haven, Florida, United States
• University of Chicago Medical Center — Chicago, Illinois, United States
• Fort Wayne Medical Oncology and Hematology — Fort Wayne, Indiana, United States
• Appalachian Regional Healthcare, Inc. — Hazard, Kentucky, United States
• Norton Healthcare - Norton Cancer Institute — Louisville, Kentucky, United States
• Center For Cancer and Blood Disorders — Bethesda, Maryland, United States
• University of Mississippi Medical Center — Jackson, Mississippi, United States
• Dayton Physicians, LLC — Kettering, Ohio, United States
• Mercy Health Youngstown Hospital, LLC — Youngstown, Ohio, United States
• Allegheny General Hospital — Pittsburgh, Pennsylvania, United States
• Millennium Oncology — Houston, Texas, United States
• Medical Oncology Associates, P.S. — Spokane, Washington, United States
• Universitair Ziekenhuis Brussel — Brussels, Belgium
• Cliniques Universitaires Saint-Luc — Brussels, Belgium
• Jewish General Hospital — Montreal, Quebec, Canada
• Cancer Hospital Chinese Academy of Medical Sciences — Beijing, China
• Chinese PLA General Hospital / 307 Hospital — Beijing, China
• Beijing Cancer Hospital - Beijing Institute for Cancer Research — Beijing, China
• Bengbu Medical College - First Affiliated Hospital — Bengbu Shi, China
• Jilin Province Cancer Hospital — Changchun, China
• First Hospital of Jilin University — Changchun, China
• Central South University - Xiangya School of Medicine - Hunan Cancer Hospital — Changsha, China
• Central South University - Xiangya School of Medicine - Hunan Cancer Hospital — Changsha-shi, China
• USC Norris Comprehensive Cancer Center — Los Angeles, California, United States

Full record on ClinicalTrials.gov

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