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.
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
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There are 39 Locations for this study
Garden City Kansas, 67846, United States
Garden City Kansas, 67846, United States
Knoxville Tennessee, 37909, United States
Knoxville Tennessee, 37932, United States
Beijing Beijing, 10014, China
Sichuan Chengdu, , China
Lanzhou Gansu, 73005, China
Guangzhou Guangdong, 51008, China
Nanning Guangxi, 53002, China
Zhengzhou Henan, 45000, China
Zhengzhou Henan, 45005, China
Wuhan Hubei, 43002, China
Changsha Hunan, 41001, China
Changsha Hunan, 41001, China
Huai'an Jiangsu, 22300, China
Xuzhou Jiangsu, 22100, China
Shangdong Qingdao, 26603, China
Jinan Shandong, 25001, China
Shanghai Shanghai, 20000, China
Shanghai Shanghai, 20003, China
Hanzhong Shanxi, 72300, China
Mianyang Sichuan, 62100, China
Tianjin Tianjin, 30005, China
Tianjin Tianjin, 30007, China
Tianjin Tianjin, 30007, China
Kunming Yunnan, 65000, China
Hangzhou Zhejiang, 31000, China
Hangzhou Zhejiang, 31002, China
Hangzhou Zhejiang, , China
Beijing , , China
Changsha , 41001, China
Changzhou , 21300, China
Guangxi , , China
Nanchang , 33000, China
Nanchong , 63700, China
Nanjing , 21002, China
Nanning , 53002, China
Shandong , 27600, China
Yantai , 26400, China
Zhejiang , , China
Zhengzhou , 45000, China
Zhenjiang , 21200, China
Gyeonggi-do Bucheon-si, 14647, Korea, Republic of
Daegu Buk-gu, 41404, Korea, Republic of
Cheongju-si Chungcheongbuk-do, 28644, Korea, Republic of
Seoul Eunpyeong-gu, 03312, Korea, Republic of
Suwon Gyeonggi-do, 16247, Korea, Republic of
Seoul Seoul Teugbyeolsi [Seoul-T'ukp, 07061, Korea, Republic of
Gyeonggi-do , , Korea, Republic of
Seoul , 06591, Korea, Republic of
Seoul , 16247, Korea, Republic of
Ulsan , 44033, Korea, Republic of
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