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

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

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.

Study Overview

• Status: Completed
• Conditions: Limited Stage Small Cell Lung Cancer
• Intervention / Treatment: Drug: Tislelizumab; Drug: Ociperlimab; Drug: Concurrent Chemoradiotherapy

• Study Type: Interventional
• Enrollment (Actual): 126
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Beijing, China
    • Peking University First Hospital
  • Changsha, China, 410013
    • Hunan Cancer Hospital
  • Changzhou, China, 213000
    • Changzhou Cancer hospital
  • Guangxi, China
    • Guangxi Medical University Affiliated Tumor Hospital
  • Nanchang, China, 330006
    • The First Affiliated Hospital of Nanchang University
  • Nanchong, China, 637000
    • Affiliated Hospital of North Sichuan Medical College
  • Nanjing, China, 210029
    • Nanjing Chest Hospital
  • Nanning, China, 530021
    • The People's Hospital of Guangxi Zhuang Autonomous Region
  • Shandong, China, 276002
    • LinYi Cancer Hospital
  • Yantai, China, 264000
    • Yantai Yuhuangding Hospital
  • Zhejiang, China
    • Hwa Mei Hospital, University of Chinese Academy of Sciences
  • Zhengzhou, China, 450003
    • Henan provincial people's hospital
  • Zhenjiang, China, 212001
    • Affiliated Hospital of Jiangsu University
  • Beijing
    • Beijing, Beijing, China, 100142
      • Beijing Cancer Hospital
  • Chengdu
    • Sichuan, Chengdu, China
      • West China Hospital of Sichuan University
  • Gansu
    • Lanzhou, Gansu, China, 730050
      • Gansu Cancer Hospital
  • Guangdong
    • Guangzhou, Guangdong, China, 510080
      • The First Affiliated Hospital, Sun Yat-sen University
  • Guangxi
    • Nanning, Guangxi, China, 530021
      • The People's Hospital of Guangxi Zhuang Autonomous Region
  • Henan
    • Zhengzhou, Henan, China, 450008
      • Henan Cancer Hospital
    • Zhengzhou, Henan, China, 450052
      • First Affiliated Hospital of Zhengzhou University
  • Hubei
    • Wuhan, Hubei, China, 430022
      • Union Hospital of Tongji Medical College, Huazhong University of Science and Technology
  • Hunan
    • Changsha, Hunan, China, 410011
      • The Second Xiangya Hospital of Central South University
    • Changsha, Hunan, China, 410011
      • The Second Xiangya Hospital central South University
  • Jiangsu
    • Huai'an, Jiangsu, China, 223002
      • Huai'an First People's Hospital
    • Xuzhou, Jiangsu, China, 221002
      • The Affiliated Hospital Of Xuzhou Medical University
  • Qingdao
    • Shangdong, Qingdao, China, 266031
      • Qingdao Shandong Central Hospital
  • Shandong
    • Jinan, Shandong, China, 250012
      • Qilu Hospital of Shandong University
  • Shanghai
    • Shanghai, Shanghai, China, 200032
      • Fudan University Affiliated Zhongshan Hospital
    • Shanghai, Shanghai, China, 20000
      • Fudan University Shanghai Cancer Center
  • Shanxi
    • Hanzhong, Shanxi, China, 723000
      • Hanzhong Central Hopital
  • Sichuan
    • Mianyang, Sichuan, China, 621000
      • Mianyang Central Hospital
  • Tianjin
    • Tianjin, Tianjin, China, 300052
      • Tianjin Medical University General Hospital
    • Tianjin, Tianjin, China, 300070
      • Tianjin Medical University Cancer Institute & Hospital
    • Tianjin, Tianjin, China, 300070
      • General Hospital of Tianjin Medical University
  • Yunnan
    • Kunming, Yunnan, China, 650000
      • The Second Affiliated Hospital of Kunming Medical University
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310022
      • Zhejiang Cancer Hospital
    • Hangzhou, Zhejiang, China
      • The First Affiliated Hospital, College of Medicine, Zhejiang University
    • Hangzhou, Zhejiang, China, 310000
      • Sir Run Run Shaw Hospital Zhejiang University School of Medicine
• Korea, Republic of
  • Gyeonggi-do, Korea, Republic of
    • Ajou University Hospital
  • Seoul, Korea, Republic of, 06591
    • The Catholic University of Korea - Seoul St. Mary's Hospital (Kangnam St. Mary's Hospital)
  • Seoul, Korea, Republic of, 16247
    • The Catholic University of Korea - St. Vincent's Hospital - Lung Cancer Center
  • Ulsan, Korea, Republic of, 44033
    • Ulsan University Hospital
  • Bucheon-si
    • Gyeonggi-do, Bucheon-si, Korea, Republic of, 14647
      • The Catholic University of Korea, Bucheon St. Mary's Hospital
  • Buk-gu
    • Daegu, Buk-gu, Korea, Republic of, 41404
      • Kyungpook National University Chilgok Hospital
  • Chungcheongbuk-do
    • Cheongju-si, Chungcheongbuk-do, Korea, Republic of, 28644
      • Chungbuk National University Hospital
  • Eunpyeong-gu
    • Seoul, Eunpyeong-gu, Korea, Republic of, 03312
      • The Catholic University of Korea Eunpyeong St. Mary's Hospital
  • Gyeonggi-do
    • Suwon, Gyeonggi-do, Korea, Republic of, 16247
      • The Catholic University of Korea - St. Vincent's Hospital
  • Seoul Teugbyeolsi [Seoul-T'ukp
    • Seoul, Seoul Teugbyeolsi [Seoul-T'ukp, Korea, Republic of, 07061
      • SMG-SNU Boramae Medical Center - Oncology
• United States
  • Kansas
    • Garden City, Kansas, United States, 67846
      • Cancer Heartland Cancer Center
    • Garden City, Kansas, United States, 67846
      • XCancer Heartland Cancer Center
  • Tennessee
    • Knoxville, Tennessee, United States, 37909
      • Xcancer Tennesee Cancer Specialist
    • Knoxville, Tennessee, United States, 37932
      • Tennesee Cancer Specialists

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm A: Ociperlimab + Tislelizumab; Ociperlimab + tislelizumab + cCRT for 4 cycles followed by ociperlimab + tislelizumab	Drug: Tislelizumab; Tislelizumab is a monoclonal antibody formulated for intravenous injection.; Other Names: BGB-A317; Drug: Ociperlimab; Ociperlimab is a monoclonal antibody formulated for intravenous injection.; Other Names: BGB-A1217; Drug: Concurrent Chemoradiotherapy; Cisplatin / Carboplatin and Etoposide, intravenous therapy Radiotherapy
Experimental: Arm B: Tislelizumab; Tislelizumab + cCRT for 4 cycles followed by tislelizumab alone	Drug: Tislelizumab; Tislelizumab is a monoclonal antibody formulated for intravenous injection.; Other Names: BGB-A317; Drug: Concurrent Chemoradiotherapy; Cisplatin / Carboplatin and Etoposide, intravenous therapy Radiotherapy
Experimental: Arm C: Concurrent Chemoradiotherapy (cCRT); cCRT for 4 cycles	Drug: Concurrent Chemoradiotherapy; Cisplatin / Carboplatin and Etoposide, intravenous therapy Radiotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: BeiGene
• Investigators: Principal Investigator: You Lu, West China Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 15, 2021
• Primary Completion (Actual): July 26, 2023
• Study Completion (Actual): July 26, 2023

Study Registration Dates

• First Submitted: June 28, 2021
• First Submitted That Met QC Criteria: June 28, 2021
• First Posted (Actual): July 7, 2021

Study Record Updates

• Last Update Posted (Actual): August 14, 2023
• Last Update Submitted That Met QC Criteria: August 11, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Small Cell Lung Carcinoma; Antineoplastic Agents; Antineoplastic Agents, Immunological; Tislelizumab
• Other Study ID Numbers: AdvanTIG-204

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No