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

Limited Stage Small Cell Lung Cancer Clinical Trial

Official title:

A Phase 2, Multicenter, Randomized, 3-Arm, Open-Label Study to Investigate the Preliminary Efficacy and Safety of the Anti-TIGIT Monoclonal Antibody Ociperlimab (BGB-A1217) Plus Tislelizumab Plus Concurrent Chemoradiotherapy in Patients With Untreated Limited-Stage Small Cell Lung Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04952597
• Other study ID #: AdvanTIG-204
• Secondary ID: CTR20211531
• Status: Completed
• Phase: Phase 2
• Start date: July 15, 2021
• Est. completion date: July 26, 2023

Study information

• Verified date: November 2023
• Source: BeiGene
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 126
• Est. completion date: July 26, 2023
• Est. primary completion date: July 26, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Limited Stage Small Cell Lung Cancer
• Lung Neoplasms
• Small Cell Lung Carcinoma

Intervention

Drug:
• Ociperlimab
Ociperlimab is a monoclonal antibody formulated for intravenous injection.
• Tislelizumab
Tislelizumab is a monoclonal antibody formulated for intravenous injection.
• Concurrent Chemoradiotherapy
Cisplatin / Carboplatin and Etoposide, intravenous therapy Radiotherapy

Locations

Country	Name	City	State
China	Beijing Cancer Hospital	Beijing	Beijing
China	Peking University First Hospital	Beijing
China	Hunan Cancer Hospital	Changsha
China	The Second Xiangya Hospital central South University	Changsha	Hunan
China	The Second Xiangya Hospital of Central South University	Changsha	Hunan
China	Changzhou Cancer Hospital	Changzhou
China	Guangxi Medical University Affiliated Tumor Hospital	Guangxi
China	The First Affiliated Hospital, Sun Yat-sen University	Guangzhou	Guangdong
China	Sir Run Run Shaw Hospital Zhejiang University School of Medicine	Hangzhou	Zhejiang
China	The First Affiliated Hospital, College of Medicine, Zhejiang University	Hangzhou	Zhejiang
China	Zhejiang Cancer Hospital	Hangzhou	Zhejiang
China	Hanzhong Central Hopital	Hanzhong	Shanxi
China	Huai'an First People's Hospital	Huai'an	Jiangsu
China	Qilu Hospital of Shandong University	Jinan	Shandong
China	The Second Affiliated Hospital of Kunming Medical University	Kunming	Yunnan
China	Gansu Cancer Hospital	Lanzhou	Gansu
China	Mianyang Central Hospital	Mianyang	Sichuan
China	The First Affiliated Hospital of Nanchang University	Nanchang
China	Affiliated Hospital of North Sichuan medical College	Nanchong
China	Nanjing Chest Hospital	Nanjing
China	The People's Hospital of Guangxi Zhuang Autonomous Region	Nanning
China	The People's Hospital of Guangxi Zhuang Autonomous Region	Nanning	Guangxi
China	Linyi Cancer Hospital	Shandong
China	Qingdao Shandong Central Hospital	Shangdong	Qingdao
China	Fudan University Affiliated Zhongshan Hospital	Shanghai	Shanghai
China	Fudan University Shanghai Cancer Center	Shanghai	Shanghai
China	West China Hospital of Sichuan University	Sichuan	Chengdu
China	General Hospital of Tianjin Medical University	Tianjin	Tianjin
China	Tianjin Medical University Cancer institute & Hospital	Tianjin	Tianjin
China	Tianjin Medical University General Hospital	Tianjin	Tianjin
China	Union Hospital of Tongji Medical College, Huazhong University of Science and Technology	Wuhan	Hubei
China	The Affiliated Hospital of Xuzhou Medical University	Xuzhou	Jiangsu
China	Yantai Yuhuangding Hospital	Yantai
China	Hwa Mei Hospital, University of Chinese Academy of Sciences	Zhejiang
China	First Affiliated Hospital of Zhengzhou University	Zhengzhou	Henan
China	Henan Cancer Hospital	Zhengzhou	Henan
China	Henan Provincial People's Hospital	Zhengzhou
China	Affiliated Hospital of Jiangsu University	Zhenjiang
Korea, Republic of	Chungbuk National University Hospital	Cheongju-si	Chungcheongbuk-do
Korea, Republic of	Kyungpook National University Chilgok Hospital	Daegu	Buk-gu
Korea, Republic of	Ajou University Hospital	Gyeonggi-do
Korea, Republic of	The Catholic University of Korea, Bucheon St. Mary's Hospital	Gyeonggi-do	Bucheon-si
Korea, Republic of	SMG-SNU Boramae Medical Center - Oncology	Seoul	Seoul Teugbyeolsi [Seoul-T'ukp
Korea, Republic of	The Catholic University of Korea - Seoul St. Mary's Hospital (Kangnam St. Mary's Hospital)	Seoul
Korea, Republic of	The Catholic University of Korea - St. Vincent's Hospital - Lung Cancer Center	Seoul
Korea, Republic of	The Catholic University of Korea Eunpyeong St. Mary's Hospital	Seoul	Eunpyeong-gu
Korea, Republic of	The Catholic University of Korea - St. Vincent's Hospital	Suwon	Gyeonggi-do
Korea, Republic of	Ulsan University Hospital	Ulsan
United States	Cancer Heartland Cancer Center	Garden City	Kansas
United States	XCancer Heartland Cancer Center	Garden City	Kansas
United States	Tennesee Cancer Specialists	Knoxville	Tennessee
United States	Xcancer Tennesee Cancer Specialist	Knoxville	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
BeiGene

Countries where clinical trial is conducted

United States,  China,  Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression free survival (PFS)	Determined from investigator derived tumor assessments per Response Evaluation Criteria in Solid Tumors (RECIST) v. 1.1.	30 months from First Patient In date
Secondary	Complete Response (CR) rate as assessed by investigator per RECIST v1.1	Determined from investigator derived tumor assessments per Response Evaluation Criteria in Solid Tumors (RECIST) v. 1.1.	30 months from First Patient In date
Secondary	Duration of response (DOR)	Determined from investigator derived tumor assessments per Response Evaluation Criteria in Solid Tumors (RECIST) v. 1.1.	30 months from First Patient In date
Secondary	Overall Response Rate (ORR)	Determined from investigator derived tumor assessments per Response Evaluation Criteria in Solid Tumors (RECIST) v. 1.1.	30 months from First Patient In date
Secondary	Overall Survival (OS)	Determined from investigator derived tumor assessments per Response Evaluation Criteria in Solid Tumors (RECIST) v. 1.1.	30 months from First Patient In date
Secondary	Safety and tolerability: The incidence and severity of treatment-emergent adverse events (TEAEs)	graded according to National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0 (NCI-CTCAE v5.0).	30 months from First Patient In date
Secondary	Distant metastasis-free survival (DMFS)	Determined from investigator derived tumor assessments per Response Evaluation Criteria in Solid Tumors (RECIST) v. 1.1.	30 months from First Patient In date