Esophageal Cancer, Esophageal Squamous Cell Carcinoma, Esophageal Squamous Cell Carcinoma by AJCC V8 Stage
Conditions
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).
Interventions
DRUGLBL-007
LBL-007 will be administered at a standard dose intravenously.
DRUGTislelizumab
Tislelizumab will be administered at a standard dose intravenously.
DRUGChemotherapy Doublet
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.
Sponsors
BeiGene
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Response Rate (ORR) | Approximately 10 months | 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
| Measure | Time frame | Description |
|---|---|---|
| Progression Free Survival (PFS) | Approximately 18 months | 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) | Approximately 18 months | 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) | Approximately 18 months | 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) | Approximately 18 months | 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. |
Countries
China, South Korea, Taiwan, Thailand
Outcome results
None listed