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NCT06010303 Clinical Trial

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

Esophageal Cancer Clinical Trial

Official 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

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT06010303
Other study ID # BGB-A317-LBL-007-202
Secondary ID CTR20233227
Status Active, not recruiting
Phase Phase 2
First received
Last updated
Start date November 8, 2023
Est. completion date September 2025

Study information
Verified date June 2024
Source BeiGene
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 118
Est. completion date September 2025
Est. primary completion date December 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Drug:
• LBL-007
LBL-007 will be administered at a standard dose intravenously.
• Tislelizumab
Tislelizumab will be administered at a standard dose intravenously.
• Chemotherapy Doublet
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.

Locations
Country Name City State
China Anyang Cancer Hospital Anyang Henan
China Peking Union Medical College Hospital Beijing Beijing
China Hunan Cancer Hospital Changsha Hunan
China The First Peoples Hospital of Changzhou Changzhou Jiangsu
China Sichuan Academy of Medical Sciences and Sichuan Provincial Peoples Hospital Chengdu Sichuan
China Sichuan Cancer Hospital and Institute Chengdu Sichuan
China Fujian Cancer Hospital Fuzhou Fujian
China Fujian Medical University Union Hospital Fuzhou Fujian
China Harbin Medical University Cancer Hospital Harbin Heilongjiang
China Anhui Provincial Hospital Hefei Anhui
China The First Affiliated Hospital of Anhui Medical University Hefei Anhui
China Shandong Cancer Hospital Jinan Shandong
China Lanzhou University Second Hospital Lanzhou Gansu
China Nanjing Drum Tower Hospital,the Affiliated Hospital of Nanjing University Medical School Nanjing Jiangsu
China The Tumor Hospital Affiliated to Guangxi Medical University Nanning Guangxi
China Nantong Tumor Hospital Branch North Nantong Jiangsu
China Nanyang Central Hospital Nanyang Henan
China The Second Affiliated Hospital of Shandong First Medical University Taian Shandong
China Tianjin Medical University Cancer Institute and Hospital Tianjin Tianjin
China The First Affiliated Hospital of Xinxiang Medical University Xinxiang Henan
China The Affiliated Hospital of Xuzhou Medical University Xuzhou Jiangsu
China General Hospital of Ningxia Medical University Yinchuan Ningxia
China Henan Cancer Hospital Zhengzhou Henan
China The First Affiliated Hospital of Zhengzhou University Zhengzhou Henan
Korea, Republic of National Cancer Center Goyangsi Gyeonggido
Korea, Republic of Chonnam National University Hwasun Hospital Hwasungun Jeonranamdo
Korea, Republic of Gachon University Gil Medical Center Incheon Incheon Gwang'yeogsi
Korea, Republic of Asan Medical Center Seoul Seoul Teugbyeolsi
Korea, Republic of Korea University Guro Hospital Seoul Seoul Teugbyeolsi
Korea, Republic of Seoul National University Hospital Seoul Seoul Teugbyeolsi
Korea, Republic of Severance Hospital Yonsei University Health System Seoul Seoul Teugbyeolsi
Korea, Republic of The Catholic University of Korea, Seoul St Marys Hospital Seoul Seoul Teugbyeolsi
Thailand Ramathibodi Hospital Mahidol University Bangkok
Thailand Siriraj Hospital Bangkok
Thailand Songklanagarind Hospital (Prince of Songkhla University) Hat Yai
Thailand Hrh Princess Maha Chakri Sirindhorn Medical Center (Srinakharinwirot University) Ongkharak
Thailand Phramongkutklao Hospital Ratchathewi

Sponsors (1)
Lead Sponsor Collaborator
BeiGene

Countries where clinical trial is conducted

China,  Korea, Republic of,  Thailand, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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. Approximately 14 months
Secondary 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. Approximately 14 months
Secondary 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. Approximately 14 months
Secondary Disease Control Rate (DCR) Percentage of participants whose BOR is CR, PR, and stable disease as assessed by the investigator per RECIST v1.1. Approximately 14 months
Secondary 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. Approximately 14 months
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