Lung Cancer Clinical Trial

Study of Ociperlimab Plus Tislelizumab Plus Chemoradiotherapy in Participants With Untreated Limited-Stage Small Cell Lung Cancer

Summary

This phase 2 trial examining the combination of ociperlimab plus tislelizumab plus cCRT is expected to provide valuable data to advance treatment options in the serious unmet medical need population of LS-SCLC patients. Immunotherapy combined with chemoradiotherapy may have a synergetic anti -cancer activities. The combination of anti-TIGIT antibody and anti-PD-1/L1 antibody may augment the immune effect with tolerable safety profile. The novel therapeutic strategy with dule immune therapy in combination with CRT is expected to provide valuable data to advance treatment options in the population of LS-SCLC patients.

View Eligibility Criteria

Eligibility Criteria

Key Inclusion Criteria:

Patient has pathologically (histologically or cytologically) proven diagnosis of small cell lung cancer
Has limited-stage disease (stage Tx, T1-T4, N0-3, M0; AJCC staging, 8th edition), and can be safely treated with definitive radiation doses.
Patient has not received any prior treatment for LS-SCLC.
Patient has measurable disease as assessed according to RECIST v1.1 that is appropriate for selection as a target lesion for repeat measurement, as determined by local site investigator/radiology review
ECOG Performance Status ≤ 2 assessed within 7 days before the first administration of study intervention, and must have a life expectancy of ≥ 12 weeks.

Key Exclusion Criteria:

Mixed small cell lung cancer histology. Note: mixed SCLC with the component of neuroendocrine carcinoma origin is considered eligible
Have received surgical resection for LS-SCLC
Any patient for whom the tumor is considered resectable by surgery or stereotactic body radiation therapy/stereotactic ablative radiotherapy should be considered ineligible
Is expected to require any other form of antineoplastic therapy while on study.
Prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-TIGIT, or any other antibody or drug specifically targeting T-cell costimulation or checkpoint pathways

Note: Other protocol-defined Inclusion/Exclusion criteria may apply

Study is for people with:

Lung Cancer

Phase:

Phase 2

Estimated Enrollment:

126

Study ID:

NCT04952597

Recruitment Status:

Active, not recruiting

Sponsor:

BeiGene

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There are 39 Locations for this study

See Locations Near You

Cancer Heartland Cancer Center
Garden City Kansas, 67846, United States
XCancer Heartland Cancer Center
Garden City Kansas, 67846, United States
Xcancer Tennesee Cancer Specialist
Knoxville Tennessee, 37909, United States
Tennesee Cancer Specialists
Knoxville Tennessee, 37932, United States
Beijing Cancer Hospital
Beijing Beijing, 10014, China
West China Hospital of Sichuan University
Sichuan Chengdu, , China
Gansu Cancer Hospital
Lanzhou Gansu, 73005, China
The First Affiliated Hospital, Sun Yat-sen University
Guangzhou Guangdong, 51008, China
The People's Hospital of Guangxi Zhuang Autonomous Region
Nanning Guangxi, 53002, China
Henan Cancer Hospital
Zhengzhou Henan, 45000, China
First Affiliated Hospital of Zhengzhou University
Zhengzhou Henan, 45005, China
Union Hospital of Tongji Medical College, Huazhong University of Science and Technology
Wuhan Hubei, 43002, China
The Second Xiangya Hospital central South University
Changsha Hunan, 41001, China
The Second Xiangya Hospital of Central South University
Changsha Hunan, 41001, China
Huai'an First People's Hospital
Huai'an Jiangsu, 22300, China
The Affiliated Hospital of Xuzhou Medical University
Xuzhou Jiangsu, 22100, China
Qingdao Shandong Central Hospital
Shangdong Qingdao, 26603, China
Qilu Hospital of Shandong University
Jinan Shandong, 25001, China
Fudan University Shanghai Cancer Center
Shanghai Shanghai, 20000, China
Fudan University Affiliated Zhongshan Hospital
Shanghai Shanghai, 20003, China
Hanzhong Central Hopital
Hanzhong Shanxi, 72300, China
Mianyang Central Hospital
Mianyang Sichuan, 62100, China
Tianjin Medical University General Hospital
Tianjin Tianjin, 30005, China
General Hospital of Tianjin Medical University
Tianjin Tianjin, 30007, China
Tianjin Medical University Cancer institute & Hospital
Tianjin Tianjin, 30007, China
The Second Affiliated Hospital of Kunming Medical University
Kunming Yunnan, 65000, China
Sir Run Run Shaw Hospital Zhejiang University School of Medicine
Hangzhou Zhejiang, 31000, China
Zhejiang Cancer Hospital
Hangzhou Zhejiang, 31002, China
The First Affiliated Hospital, College of Medicine, Zhejiang University
Hangzhou Zhejiang, , China
Peking University First Hospital
Beijing , , China
Hunan Cancer Hospital
Changsha , 41001, China
Changzhou Cancer Hospital
Changzhou , 21300, China
Guangxi Medical University Affiliated Tumor Hospital
Guangxi , , China
The First Affiliated Hospital of Nanchang University
Nanchang , 33000, China
Affiliated Hospital of North Sichuan medical College
Nanchong , 63700, China
Nanjing Chest Hospital
Nanjing , 21002, China
The People's Hospital of Guangxi Zhuang Autonomous Region
Nanning , 53002, China
Linyi Cancer Hospital
Shandong , 27600, China
Yantai Yuhuangding Hospital
Yantai , 26400, China
Hwa Mei Hospital, University of Chinese Academy of Sciences
Zhejiang , , China
Henan Provincial People's Hospital
Zhengzhou , 45000, China
Affiliated Hospital of Jiangsu University
Zhenjiang , 21200, China
The Catholic University of Korea, Bucheon St. Mary's Hospital
Gyeonggi-do Bucheon-si, 14647, Korea, Republic of
Kyungpook National University Chilgok Hospital
Daegu Buk-gu, 41404, Korea, Republic of
Chungbuk National University Hospital
Cheongju-si Chungcheongbuk-do, 28644, Korea, Republic of
The Catholic University of Korea Eunpyeong St. Mary's Hospital
Seoul Eunpyeong-gu, 03312, Korea, Republic of
The Catholic University of Korea - St. Vincent's Hospital
Suwon Gyeonggi-do, 16247, Korea, Republic of
SMG-SNU Boramae Medical Center - Oncology
Seoul Seoul Teugbyeolsi [Seoul-T'ukp, 07061, Korea, Republic of
Ajou University Hospital
Gyeonggi-do , , Korea, Republic of
The Catholic University of Korea - Seoul St. Mary's Hospital (Kangnam St. Mary's Hospital)
Seoul , 06591, Korea, Republic of
The Catholic University of Korea - St. Vincent's Hospital - Lung Cancer Center
Seoul , 16247, Korea, Republic of
Ulsan University Hospital
Ulsan , 44033, Korea, Republic of

How clear is this clinincal trial information?

Study is for people with:

Lung Cancer

Phase:

Phase 2

Estimated Enrollment:

126

Study ID:

NCT04952597

Recruitment Status:

Active, not recruiting

Sponsor:


BeiGene

How clear is this clinincal trial information?

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