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Completed

NCT Number: NCT06010303

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

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).

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Key information

Conditions

Esophageal Cancer Carcinoma Carcinoma, Squamous Cell Digestive System Diseases Digestive System Neoplasms Esophageal Diseases Esophageal Neoplasms Esophageal Squamous Cell Carcinoma Esophageal Squamous Cell Carcinoma by AJCC V8 Stage Gastrointestinal Diseases Gastrointestinal Neoplasms Head and Neck Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Neoplasms, Squamous Cell

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Anhui Provincial Hospital, Hefei, Anhui, China

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

LBL-007

Drug

LBL-007 will be administered at a standard dose intravenously.

Other names: Alcestobart

Tislelizumab

Drug

Tislelizumab will be administered at a standard dose intravenously.

Other names: BGB-A317

Chemotherapy Doublet

Drug

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 outcomes

  1. Overall Response Rate (ORR)

    Time frame: 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 outcomes

  1. Progression Free Survival (PFS)

    Time frame: 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.

  2. Duration of Response (DOR)

    Time frame: 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.

  3. Disease Control Rate (DCR)

    Time frame: Approximately 18 months

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

  4. Number of Participants with Adverse Events (AEs)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

BeiGene

Industry

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2025
Study completion
2026
First posted
Aug 24, 2023
Registry last updated
May 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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