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 2

Active, not recruiting

• Conditions: Esophageal Cancer; Esophageal Squamous Cell Carcinoma; Esophageal Squamous Cell Carcinoma by AJCC V8 Stage
• Interventions: Drug: LBL-007; Drug: Tislelizumab; Drug: Chemotherapy Doublet

• Registration Number: NCT06010303
• Lead Sponsor: BeiGene

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-08-21
• Study First Submitted QC: 2023-08-21
• Study First Posted: 2023-08-24
• Study Start: 2023-11-08
• Primary Completion: 2024-09-11
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-19
• Last Update Posted: 2025-05-22
• Study Completion: 2026-05-23

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 118

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
LBL-007	Chemotherapy Doublet	LBL-007 in combination with tislelizumab plus chemotherapy doublet.
LBL-007	Tislelizumab	LBL-007 in combination with tislelizumab plus chemotherapy doublet.
Tislelizumab and Chemotherapy	Tislelizumab	Tislelizumab plus chemotherapy doublet.
Tislelizumab and Chemotherapy	Chemotherapy Doublet	Tislelizumab plus chemotherapy doublet.
LBL-007	LBL-007	LBL-007 in combination with tislelizumab plus chemotherapy doublet.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
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.
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.

Trial Locations

Locations (38)

Changhua Christian Hospital; 🇨🇳 Changhua, Taiwan

Kaohsiung Medical University Chung Ho Memorial Hospital; 🇨🇳 Kaohsiung, Taiwan

China Medical University Hospital; 🇨🇳 Taichung, Taiwan

National Taiwan University Hospital; 🇨🇳 Taipei, Taiwan

Taipei Veterans General Hospital; 🇨🇳 Taipei, Taiwan

Anhui Provincial Hospital; 🇨🇳 Hefei, Anhui, China

The First Affiliated Hospital of Anhui Medical University; 🇨🇳 Hefei, Anhui, China

Peking Union Medical College Hospital; 🇨🇳 Beijing, Beijing, China

Fujian Medical University Union Hospital; 🇨🇳 Fuzhou, Fujian, China

Fujian Cancer Hospital; 🇨🇳 Fuzhou, Fujian, China

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