A Study to Evaluate LBL-007 in Combination With Tislelizumab Plus Chemotherapy in Participants With Unresectable Locally Advanced or Metastatic Esophageal Squamous Cell Carcinoma
- Conditions
- Esophageal CancerEsophageal Squamous Cell CarcinomaEsophageal Squamous Cell Carcinoma by AJCC V8 Stage
- Interventions
- 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
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 118
- 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.
- 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.
Related Research Topics
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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
Lanzhou University Second Hospital
🇨🇳Lanzhou, Gansu, China
The Tumor Hospital Affiliated to Guangxi Medical University
🇨🇳Nanning, Guangxi, China
Harbin Medical University Cancer Hospital
🇨🇳Harbin, Heilongjiang, China
Anyang Cancer Hospital
🇨🇳Anyang, Henan, China
Nanyang Central Hospital
🇨🇳Nanyang, Henan, China
The First Affiliated Hospital of Xinxiang Medical University
🇨🇳Xinxiang, Henan, China
Henan Cancer Hospital
🇨🇳Zhengzhou, Henan, China
The First Affiliated Hospital of Zhengzhou University
🇨🇳Zhengzhou, Henan, China
Hunan Cancer Hospital
🇨🇳Changsha, Hunan, China
The First Peoples Hospital of Changzhou
🇨🇳Changzhou, Jiangsu, China
Nanjing Drum Tower Hospital,the Affiliated Hospital of Nanjing University Medical School
🇨🇳Nanjing, Jiangsu, China
Nantong Tumor Hospital Branch North
🇨🇳Nantong, Jiangsu, China
The Affiliated Hospital of Xuzhou Medical University
🇨🇳Xuzhou, Jiangsu, China
General Hospital of Ningxia Medical University
🇨🇳Yinchuan, Ningxia, China
Shandong Cancer Hospital
🇨🇳Jinan, Shandong, China
The Second Affiliated Hospital of Shandong First Medical University
🇨🇳Taian, Shandong, China
Sichuan Cancer Hospital and Institute
🇨🇳Chengdu, Sichuan, China
Sichuan Academy of Medical Sciences and Sichuan Provincial Peoples Hospital
🇨🇳Chengdu, Sichuan, China
Tianjin Medical University Cancer Institute and Hospital
🇨🇳Tianjin, Tianjin, China
National Cancer Center
🇰🇷Goyangsi, Gyeonggi-do, Korea, Republic of
Chonnam National University Hwasun Hospital
🇰🇷HwasunGun, Jeollanam-do, Korea, Republic of
Seoul National University Hospital
🇰🇷Seoul, Seoul Teugbyeolsi, Korea, Republic of
The Catholic University of Korea, Seoul St Marys Hospital
🇰🇷Seoul, Seoul Teugbyeolsi, Korea, Republic of
Severance Hospital Yonsei University Health System
🇰🇷Seoul, Seoul Teugbyeolsi, Korea, Republic of
Ramathibodi Hospital Mahidol University
🇹🇭Bangkok, Thailand
Siriraj Hospital
🇹🇭Bangkok, Thailand
Hrh Princess Maha Chakri Sirindhorn Medical Center (Srinakharinwirot University)
🇹🇭Ongkharak, Thailand
Phramongkutklao Hospital
🇹🇭Ratchathewi, Thailand