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 examined whether the preliminary efficacy and safety of ociperlimab, tislelizumab, and cCRT when used in combination is expected to advance treatment options in the serious unmet medical need population of Limited-Stage Small Cell Lung Cancer (LS-SCLC) participants .

Study Overview

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

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

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100034
      • Peking University First Hospital
    • Beijing, Beijing, China, 100142
      • Beijing Cancer Hospital
  • Gansu
    • Lanzhou, Gansu, China, 730050
      • Gansu Provincial Cancer Hospital
  • Guangdong
    • Guangzhou, Guangdong, China, 510080
      • The First Affiliated Hospital, Sun Yat Sen University
  • Guangxi
    • Nanning, Guangxi, China, 530021
      • The Tumor Hospital Affiliated to Guangxi Medical University
  • Henan
    • Zhengzhou, Henan, China, 450052
      • The First Affiliated Hospital of Zhengzhou University
    • Zhengzhou, Henan, China, 450000
      • Henan Cancer Hospital
  • Hubei
    • Wuhan, Hubei, China, 430022
      • Union Hospital of Tongji Medical College, Huazhong University of Science and Technology
  • Hunan
    • Changsha, Hunan, China, 410013
      • Hunan Cancer Hospital
    • Changsha, Hunan, China, 410011
      • The Second Xiangya Hospital of Central South University
  • Jiangsu
    • Huaian, Jiangsu, China, 223300
      • Huai An First Peoples Hospital
    • Nanjing, Jiangsu, China, 210029
      • Nanjing Chest Hospital
    • Xuzhou, Jiangsu, China, 221000
      • The Affiliated Hospital of Xuzhou Medical University
  • Shaanxi
    • Hanzhong, Shaanxi, China, 72300
      • Hanzhong Central Hospital
  • Shandong
    • Jinan, Shandong, China, 250000
      • Qilu Hospital of Shandong University
    • Linyi, Shandong, China, 276001
      • Linyi Cancer Hospital
    • Qingdao, Shandong, China, 266031
      • Qingdao Central Hospital
    • Yantai, Shandong, China, 264000
      • Yantai Yuhuangding Hospital
  • Shanghai
    • Shanghai, Shanghai, China, 200000
      • Fudan University Shanghai Cancer Center
    • Shanghai, Shanghai, China, 200032
      • Affiliated Zhongshan Hospital of Fudan University
  • Sichuan
    • Chengdu, Sichuan, China, 610041
      • West China Hospital, Sichuan University
    • Nanchong, Sichuan, China, 637000
      • Affiliated Hospital of North Sichuan Medical College
  • Tianjin
    • Tianjin, Tianjin, China, 300060
      • Tianjin Medical University Cancer Institute and Hospital
    • Tianjin, Tianjin, China, 300052
      • Tianjin Medical University General Hospital
  • Yunnan
    • Kunming, Yunnan, China, 650000
      • The Second Affiliated Hospital of Kunming Medical University
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310022
      • Zhejiang Cancer Hospital
    • Ningbo, Zhejiang, China, 315000
      • Hwa Mei Hospital, University of Chinese Academy of Sciences (Ningbo No Hospital)
• Korea, Republic of
  • Chungcheongbukdo
    • Cheongjusi, Chungcheongbukdo, Korea, Republic of, 28644
      • Chungbuk National University Hospital
  • Gyeonggi-do
    • Gyeonggido, Gyeonggi-do, Korea, Republic of, 13496
      • CHA Bundang Medical Center, CHA University
    • Suwonsi, Gyeonggi-do, Korea, Republic of, 16247
      • The Catholic University of Korea, St Vincents Hospital
    • Suwonsi, Gyeonggi-do, Korea, Republic of, 16499
      • Ajou University Hospital
  • Gyeongsangbukdo
    • Daegu, Gyeongsangbukdo, Korea, Republic of, 41404
      • Kyungpook National University Chilgok Hospital
• United States
  • Tennessee
    • Knoxville, Tennessee, United States, 37909
      • Tennessee Cancer Specialist

Participation Criteria

Eligibility Criteria

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

Description

Key Inclusion Criteria:

• Participant 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.
• Participant has not received any prior treatment for LS-SCLC.
• Participant 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 participant 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 plus tislelizumab combined with cCRT (at the investigator's discretion) for 4 cycles (each cycle is 28 days), followed by ociperlimab plus tislelizumab	Drug: Ociperlimab; Ociperlimab 900 milligrams (mg) administered intravenously once every 3 weeks on Day 1 of each cycle; Other Names: BGB-A1217; Drug: Tislelizumab; Tislelizumab 200 mg administered intravenously once every 3 weeks on Day 1 of each cycle; Other Names: BGB-A317; Drug: Concurrent Chemoradiotherapy; Cisplatin/Carboplatin: Either cisplatin 75 milligrams/meters squared (mg/m2) administered intravenously once every 3 weeks on Day 1 of each cycle for 4 cycles or carboplatin at a dose of area under the curve (AUC) 5 administered intravenously once every 3 weeks on Day 1 of each cycle for 4 cycles. Etoposide: (100 mg/m2) administered intravenously on Days 1, 2, and 3 of each cycle for 4 cycles Thoracic radiation therapy (TRT): once daily fractions for 6 to 7 weeks for a total dose of 60 to 70 units of absorbed dose of ionizing radiation (Gy)
Experimental: Arm B: Tislelizumab; Tislelizumab combined with cCRT (at the investigator's discretion) for 4 cycles, followed by tislelizumab alone	Drug: Tislelizumab; Tislelizumab 200 mg administered intravenously once every 3 weeks on Day 1 of each cycle; Other Names: BGB-A317; Drug: Concurrent Chemoradiotherapy; Cisplatin/Carboplatin: Either cisplatin 75 milligrams/meters squared (mg/m2) administered intravenously once every 3 weeks on Day 1 of each cycle for 4 cycles or carboplatin at a dose of area under the curve (AUC) 5 administered intravenously once every 3 weeks on Day 1 of each cycle for 4 cycles. Etoposide: (100 mg/m2) administered intravenously on Days 1, 2, and 3 of each cycle for 4 cycles Thoracic radiation therapy (TRT): once daily fractions for 6 to 7 weeks for a total dose of 60 to 70 units of absorbed dose of ionizing radiation (Gy)
Experimental: Arm C: Concurrent Chemoradiotherapy (cCRT); cCRT only for 4 cycles at the investigator's discretion	Drug: Concurrent Chemoradiotherapy; Cisplatin/Carboplatin: Either cisplatin 75 milligrams/meters squared (mg/m2) administered intravenously once every 3 weeks on Day 1 of each cycle for 4 cycles or carboplatin at a dose of area under the curve (AUC) 5 administered intravenously once every 3 weeks on Day 1 of each cycle for 4 cycles. Etoposide: (100 mg/m2) administered intravenously on Days 1, 2, and 3 of each cycle for 4 cycles Thoracic radiation therapy (TRT): once daily fractions for 6 to 7 weeks for a total dose of 60 to 70 units of absorbed dose of ionizing radiation (Gy)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression Free Survival (PFS)	Defined as the time from the date of randomization to the date of the first documented disease progression as determined by the investigator per RECIST v1.1 or death from any cause (whichever occurs first)	Up to approximately 2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complete Response Rate (CR)	defined as the percentage of participants who had CR as assessed by the investigator per RECIST v1.1	Up to approximately 2 years
Overall Response Rate (ORR)	defined as the percentage of participants who had CR or partial response (PR) as assessed by the investigator per RECIST v1.1	Up to approximately 2 years
Overall Response Rate (ORR) in the Programmed Death-Ligand 1 (PD-L1) Analysis Set	defined as the percentage of participants who had CR or partial response (PR) as assessed by the investigator per RECIST v1.1	Up to approximately 2 years
Overall Response Rate (ORR) in the T Cell Immunoreceptor With Immunoglobulin and ITIM Domain (TIGIT) Analysis Set	defined as the percentage of participants who had CR or partial response (PR) as assessed by the investigator per RECIST v1.1	Up to approximately 2 years
Duration of Response (DOR)	defined as the time from the date of the first occurrence of a documented objective response to the date of documented disease progression as assessed by the investigator per RECIST v1.1 or death from any cause (whichever occurs first)	Up to approximately 2 years
Overall Survival (OS) in the ITT Analysis Set	Defined as the time from the date of randomization to the date of death due to any cause	Up to approximately 2 years
Overall Survival (OS) in the PD-L1 Analysis Set	defined as the time from the date of randomization to the date of death due to any cause	Up to approximately 2 years
Overall Survival (OS) in the TIGIT Analysis Set	defined as the time from the date of randomization to the date of death due to any cause	Up to approximately 2 years
Distant Metastasis-free Survival (DMFS)	defined as the time from the date of randomization to the date of the first documented distant metastasis as assessed by the investigator per RECIST v1.1 or death from any cause (whichever occurs first)	Up to approximately 2 years
PFS in the PD-L1 Analysis Set	defined as the time from the date of randomization to the date of the first documented disease progression as determined by the investigator per RECIST v1.1 or death from any cause (whichever occurs first),	Up to approximately 2 years
PFS in the TIGIT Analysis Set	defined as the time from the date of randomization to the date of the first documented disease progression as determined by the investigator per RECIST v1.1 or death from any cause (whichever occurs first),	Up to approximately 2 years
Number of Participants Experiencing Adverse Events (AEs)	Number of participants with treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), v4.03	From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years

Collaborators and Investigators

• Sponsor: BeiGene
• Investigators: Study Director: BeiGene, Study Director

Publications and helpful links

General Publications

• Youling Gong, Qingsong Pang, Rong Yu, Zhengfei Zhu, Jiangqiong Huang, Yufeng Cheng, Diansheng Zhong, Hongbo Wu, Seung Soo Yoo, Tracy Dobbs, Zinan Bao, Yunxia Zuo, Boxian Wei, Pu Sun, You Lu; Abstract CT255: AdvanTIG-204: A phase 2, multicenter, randomized, 3-arm, open-label study investigating the preliminary efficacy and safety of ociperlimab (anti-TIGIT) + tislelizumab (anti-PD-1) + concurrent chemoradiotherapy (cCRT) in patients with untreated limited-stage small cell lung cancer (SCLC). Cancer Res 1 April 2024; 84 (7_Supplement): CT255. https://doi.org/10.1158/1538-7445.AM2024-CT255

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): October 26, 2024
• Last Update Submitted That Met QC Criteria: October 23, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Lung Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Small Cell Lung Carcinoma; Antineoplastic Agents, Immunological; Antineoplastic Agents; Tislelizumab
• Other Study ID Numbers: AdvanTIG-204; CTR20211531 (Other Identifier: ChinaDrugTrials); BGB-A317-A1217-204 (Other Identifier: BeiGene ID)

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