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



Status:Recruiting
Conditions:Lung Cancer, Lung Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:1/17/2019
Start Date:January 7, 2019
End Date:October 26, 2023
Contact:Associate Director Clinical Trial Disclosure
Email:clinicaltrialdisclosure@celgene.com
Phone:1-888-260-1599

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A PHASE 3, RANDOMIZED, BLINDED, PLACEBO-CONTROLLED 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 PFS in the intent-to-treat (ITT) population. Newly diagnosed
stage III subjects with histologically confirmed, locally advanced, unresectable NSCLC are
eligible.


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 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. EGFR mutation and 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 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.
We found this trial at
5
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Hazard, Kentucky
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11143 Parkview Plaza Dr # 100
Fort Wayne, Indiana 46845
(260) 484-8830
Fort Wayne Medical Oncology and Hematology Fort Wayne Medical Oncology and Hematology provides state-of-the-art cancer...
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Fort Wayne, IN
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6410 Rockledge Dr #660
Bethesda, Maryland 20817
(301) 571-0019
Center for Cancer & Blood Disorders Widely recognized for its compassionate, expert care, the Center...
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Bethesda, MD
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Houston, Texas 77090
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Houston, TX
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Spokane, Washington 99208
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Spokane, WA
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