Active — Not RecruitingPhase 2

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

China118 participantsStarted 2023-11-08

Plain-language 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).

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Overall Response Rate (ORR)

Timeframe: Approximately 10 months

Trial details

NCT IDNCT06010303

SponsorBeiGene

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-05-30

View on ClinicalTrials.gov More Esophageal Cancer trials