Clinical trial 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
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Esophageal Cancer
Esophageal Squamous Cell Carcinoma
Esophageal Squamous Cell Carcinoma by AJCC V8 Stage
Lead sponsor: BeiGene
Sponsor class: INDUSTRY
First posted: 2023-08-24
Enrollment: 118
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


Eligibility criteria: 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.

Primary outcomes:
measure: Overall Response Rate (ORR)
timeFrame: Approximately 10 months
Secondary outcomes:
measure: Progression Free Survival (PFS)
timeFrame: Approximately 18 months
measure: Duration of Response (DOR)
timeFrame: Approximately 18 months
measure: Disease Control Rate (DCR)
timeFrame: Approximately 18 months
measure: Number of Participants with Adverse Events (AEs)
timeFrame: Approximately 18 months
Other outcomes:
Locations:
city: Hefei
country: China
facility: Anhui Provincial Hospital
state: Anhui
city: Hefei
country: China
facility: The First Affiliated Hospital of Anhui Medical University
state: Anhui
city: Beijing
country: China
facility: Peking Union Medical College Hospital
state: Beijing
city: Fuzhou
country: China
facility: Fujian Medical University Union Hospital
state: Fujian
city: Fuzhou
country: China
facility: Fujian Cancer Hospital
state: Fujian
city: Lanzhou
country: China
facility: Lanzhou University Second Hospital
state: Gansu
city: Nanning
country: China
facility: The Tumor Hospital Affiliated to Guangxi Medical University
state: Guangxi
city: Harbin
country: China
facility: Harbin Medical University Cancer Hospital
state: Heilongjiang
city: Anyang
country: China
facility: Anyang Cancer Hospital
state: Henan
city: Nanyang
country: China
facility: Nanyang Central Hospital
state: Henan
city: Xinxiang
country: China
facility: The First Affiliated Hospital of Xinxiang Medical University
state: Henan
city: Zhengzhou
country: China
facility: Henan Cancer Hospital
state: Henan
city: Zhengzhou
country: China
facility: The First Affiliated Hospital of Zhengzhou University
state: Henan
city: Changsha
country: China
facility: Hunan Cancer Hospital
state: Hunan
city: Changzhou
country: China
facility: The First Peoples Hospital of Changzhou
state: Jiangsu
city: Nanjing
country: China
facility: Nanjing Drum Tower Hospital,the Affiliated Hospital of Nanjing University Medical School
state: Jiangsu
city: Nantong
country: China
facility: Nantong Tumor Hospital Branch North
state: Jiangsu
city: Xuzhou
country: China
facility: The Affiliated Hospital of Xuzhou Medical University
state: Jiangsu
city: Yinchuan
country: China
facility: General Hospital of Ningxia Medical University
state: Ningxia
city: Jinan
country: China
facility: Shandong Cancer Hospital
state: Shandong
city: Taian
country: China
facility: The Second Affiliated Hospital of Shandong First Medical University
state: Shandong
city: Chengdu
country: China
facility: Sichuan Cancer Hospital and Institute
state: Sichuan
city: Chengdu
country: China
facility: Sichuan Academy of Medical Sciences and Sichuan Provincial Peoples Hospital
state: Sichuan
city: Tianjin
country: China
facility: Tianjin Medical University Cancer Institute and Hospital
state: Tianjin
city: Goyangsi
country: Korea, Republic of
facility: National Cancer Center
state: Gyeonggi-do
city: HwasunGun
country: Korea, Republic of
facility: Chonnam National University Hwasun Hospital
state: Jeollanam-do
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
state: Seoul Teugbyeolsi
city: Seoul
country: Korea, Republic of
facility: Severance Hospital Yonsei University Health System
state: Seoul Teugbyeolsi
city: Seoul
country: Korea, Republic of
facility: The Catholic University of Korea, Seoul St Marys Hospital
state: Seoul Teugbyeolsi
city: Changhua
country: Taiwan
facility: Changhua Christian Hospital
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Medical University Chung Ho Memorial Hospital
city: Taichung
country: Taiwan
facility: China Medical University Hospital
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hospital
city: Bangkok
country: Thailand
facility: Ramathibodi Hospital Mahidol University
city: Bangkok
country: Thailand
facility: Siriraj Hospital
city: Ongkharak
country: Thailand
facility: Hrh Princess Maha Chakri Sirindhorn Medical Center (Srinakharinwirot University)
city: Ratchathewi
country: Thailand
facility: Phramongkutklao Hospital
Study officials:
affiliation: BeiGene
name: Study Director
role: STUDY_DIRECTOR
References: