Back to resultsA Study to Evaluate LBL-007 in Combination With Tislelizumab Plus Chemotherapy in Participants With Unresectable Locally Advanced or Metastatic Esophageal Squamous Cell Carcinoma
Primary Purpose
Esophageal Cancer, Esophageal Squamous Cell Carcinoma, Esophageal Squamous Cell Carcinoma by AJCC V8 Stage
Status
Not yet recruiting
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
LBL-007
Tislelizumab
Chemotherapy Doublet
Sponsored by
About this trial
This is an interventional treatment trial for Esophageal Cancer
Eligibility Criteria
Inclusion Criteria: Able to provide written informed consent and can agree to comply with the study requirements. Participants with metastatic ESCC or unresectable, locally advanced ESCC. Histologically confirmed diagnosis of ESCC. Can provide a tumor sample. At least 1 measurable lesion as defined by RECIST v1.1. Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 1. Exclusion Criteria: Prior treatment for advanced or metastatic ESCC within the past 6 months Locally advanced ESCC that is either resectable or potentially curable with definitive chemoradiation treatment per local investigator Palliative radiation treatment for ESCC within the past 4 weeks Participants with an esophageal/bronchial or esophageal/aorta fistula Prior treatment with programmed cell death protein-1 (PD-1) or other immune-oncological drugs Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
LBL-007
Tislelizumab and Chemotherapy
Arm Description
LBL-007 in combination with tislelizumab plus chemotherapy doublet.
Tislelizumab plus chemotherapy doublet.
Outcomes
Primary Outcome Measures
Overall Response Rate (ORR)
Percentage of participants whose best overall response (BOR) is complete response (CR) or partial response (PR) as assessed by the investigator per Response Evaluation Criteria for Solid Tumors (RECIST) v1.1.
Secondary Outcome Measures
Progression Free Survival (PFS)
Time from the date of randomization to the date of first documentation of disease progression assessed by the investigator per RECIST v1.1 or death, whichever occurs first.
Duration of Response (DOR)
Time from the first determination of an overall response until the first documentation of progression assessed by the investigator per RECIST v1.1 or death, whichever occurs first.
Disease Control Rate (DCR)
Percentage of participants whose BOR is CR, PR, and stable disease as assessed by the investigator per RECIST v1.1.
Number of Participants with Adverse Events (AEs)
Number of participants with AEs, including findings from physical examinations, electrocardiograms, and laboratory assessments according to the National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) v5.0.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT06010303
Brief Title
A Study to Evaluate LBL-007 in Combination With Tislelizumab Plus Chemotherapy in Participants With Unresectable Locally Advanced or Metastatic Esophageal Squamous Cell Carcinoma
Official Title
A Phase 2, Randomized, Active-Controlled, Open-Label Study to Evaluate the Efficacy and Safety of LBL-007 in Combination With Tislelizumab Plus Chemotherapy as First-Line Treatment in Patients With Unresectable Locally Advanced or Metastatic Esophageal Squamous Cell Carcinoma
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
November 2023 (Anticipated)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
September 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
BeiGene
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This is a randomized, open-label study to compare how well LBL-007 works in combination with tislelizumab and chemotherapy versus tislelizumab and chemotherapy when given as the first-line treatment in participants with inoperable locally advanced or metastatic esophageal squamous cell carcinoma (ESCC).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Esophageal Cancer, Esophageal Squamous Cell Carcinoma, Esophageal Squamous Cell Carcinoma by AJCC V8 Stage
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
116 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
LBL-007
Arm Type
Experimental
Arm Description
LBL-007 in combination with tislelizumab plus chemotherapy doublet.
Arm Title
Tislelizumab and Chemotherapy
Arm Type
Active Comparator
Arm Description
Tislelizumab plus chemotherapy doublet.
Intervention Type
Drug
Intervention Name(s)
LBL-007
Intervention Description
LBL-007 will be administered at a standard dose intravenously.
Intervention Type
Drug
Intervention Name(s)
Tislelizumab
Other Intervention Name(s)
BGB-A317
Intervention Description
Tislelizumab will be administered at a standard dose intravenously.
Intervention Type
Drug
Intervention Name(s)
Chemotherapy Doublet
Intervention Description
Doublet 1: cisplatin + 5-fluorouracil Doublet 2: cisplatin + paclitaxel
Choice of chemotherapy doublet will be determined by the investigator and will be administered at standard doses intravenously.
Primary Outcome Measure Information:
Title
Overall Response Rate (ORR)
Description
Percentage of participants whose best overall response (BOR) is complete response (CR) or partial response (PR) as assessed by the investigator per Response Evaluation Criteria for Solid Tumors (RECIST) v1.1.
Time Frame
Approximately 14 months
Secondary Outcome Measure Information:
Title
Progression Free Survival (PFS)
Description
Time from the date of randomization to the date of first documentation of disease progression assessed by the investigator per RECIST v1.1 or death, whichever occurs first.
Time Frame
Approximately 14 months
Title
Duration of Response (DOR)
Description
Time from the first determination of an overall response until the first documentation of progression assessed by the investigator per RECIST v1.1 or death, whichever occurs first.
Time Frame
Approximately 14 months
Title
Disease Control Rate (DCR)
Description
Percentage of participants whose BOR is CR, PR, and stable disease as assessed by the investigator per RECIST v1.1.
Time Frame
Approximately 14 months
Title
Number of Participants with Adverse Events (AEs)
Description
Number of participants with AEs, including findings from physical examinations, electrocardiograms, and laboratory assessments according to the National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) v5.0.
Time Frame
Approximately 14 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Able to provide written informed consent and can agree to comply with the study requirements.
Participants with metastatic ESCC or unresectable, locally advanced ESCC.
Histologically confirmed diagnosis of ESCC.
Can provide a tumor sample.
At least 1 measurable lesion as defined by RECIST v1.1.
Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 1.
Exclusion Criteria:
Prior treatment for advanced or metastatic ESCC within the past 6 months
Locally advanced ESCC that is either resectable or potentially curable with definitive chemoradiation treatment per local investigator
Palliative radiation treatment for ESCC within the past 4 weeks
Participants with an esophageal/bronchial or esophageal/aorta fistula
Prior treatment with programmed cell death protein-1 (PD-1) or other immune-oncological drugs
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Study Director
Phone
1.877.828.5568
Email
clinicaltrials@beigene.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Study Director
Organizational Affiliation
BeiGene
Official's Role
Study Director
12. IPD Sharing Statement
Plan to Share IPD
Yes
Learn more about this trial
A Study to Evaluate LBL-007 in Combination With Tislelizumab Plus Chemotherapy in Participants With Unresectable Locally Advanced or Metastatic Esophageal Squamous Cell Carcinoma
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