A Study to Evaluate LBL-007 in Combination With Tislelizumab Plus Chemotherapy in Participants With Unresectable Locally Advanced or Metastatic Esophageal Squamous Cell Carcinoma

Phase 2Active Not RecruitingNCT06010303

BeiGene118 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

118

Conditions

Esophageal Cancer Esophageal Squamous Cell Carcinoma Esophageal Squamous Cell Carcinoma by AJCC V8 Stage

Interventions

Chemotherapy DoubletDRUG

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (38)

Anhui Provincial Hospital

Hefei, Anhui, China

The First Affiliated Hospital of Anhui Medical University

Hefei, Anhui, China

Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

Fujian Medical University Union Hospital

Fuzhou, Fujian, China

Fujian Cancer Hospital

Fuzhou, Fujian, China

Outcomes

Primary Outcomes

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.

Time frame: Approximately 10 months

Secondary Outcomes

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.

Time frame: Approximately 18 months

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.

Time frame: Approximately 18 months

Disease Control Rate (DCR)

Percentage of participants whose BOR is CR, PR, and stable disease as assessed by the investigator per RECIST v1.1.

Time frame: Approximately 18 months

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.

Time frame: Approximately 18 months