Back to resultsStudy of Ociperlimab Plus Tislelizumab Plus Chemoradiotherapy in Participants With Untreated Limited-Stage Small Cell Lung Cancer
Primary Purpose
Limited Stage Small Cell Lung Cancer
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Ociperlimab
Tislelizumab
Concurrent Chemoradiotherapy
Sponsored by
About this trial
This is an interventional treatment trial for Limited Stage Small Cell Lung Cancer
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
Sites / Locations
- Cancer Heartland Cancer Center
- XCancer Heartland Cancer Center
- Xcancer Tennesee Cancer Specialist
- Tennesee Cancer Specialists
- Beijing Cancer Hospital
- West China Hospital of Sichuan University
- Gansu Cancer Hospital
- The First Affiliated Hospital, Sun Yat-sen University
- The People's Hospital of Guangxi Zhuang Autonomous Region
- Henan Cancer Hospital
- First Affiliated Hospital of Zhengzhou University
- Union Hospital of Tongji Medical College, Huazhong University of Science and Technology
- The Second Xiangya Hospital central South University
- The Second Xiangya Hospital of Central South University
- Huai'an First People's Hospital
- The Affiliated Hospital of Xuzhou Medical University
- Qingdao Shandong Central Hospital
- Qilu Hospital of Shandong University
- Fudan University Shanghai Cancer Center
- Fudan University Affiliated Zhongshan Hospital
- Hanzhong Central Hopital
- Mianyang Central Hospital
- Tianjin Medical University General Hospital
- General Hospital of Tianjin Medical University
- Tianjin Medical University Cancer institute & Hospital
- The Second Affiliated Hospital of Kunming Medical University
- Sir Run Run Shaw Hospital Zhejiang University School of Medicine
- Zhejiang Cancer Hospital
- The First Affiliated Hospital, College of Medicine, Zhejiang University
- Peking University First Hospital
- Hunan Cancer Hospital
- Changzhou Cancer Hospital
- Guangxi Medical University Affiliated Tumor Hospital
- The First Affiliated Hospital of Nanchang University
- Affiliated Hospital of North Sichuan medical College
- Nanjing Chest Hospital
- The People's Hospital of Guangxi Zhuang Autonomous Region
- Linyi Cancer Hospital
- Yantai Yuhuangding Hospital
- Hwa Mei Hospital, University of Chinese Academy of Sciences
- Henan Provincial People's Hospital
- Affiliated Hospital of Jiangsu University
- The Catholic University of Korea, Bucheon St. Mary's Hospital
- Kyungpook National University Chilgok Hospital
- Chungbuk National University Hospital
- The Catholic University of Korea Eunpyeong St. Mary's Hospital
- The Catholic University of Korea - St. Vincent's Hospital
- SMG-SNU Boramae Medical Center - Oncology
- Ajou University Hospital
- The Catholic University of Korea - Seoul St. Mary's Hospital (Kangnam St. Mary's Hospital)
- The Catholic University of Korea - St. Vincent's Hospital - Lung Cancer Center
- Ulsan University Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Arm A: Ociperlimab + Tislelizumab
Arm B: Tislelizumab
Arm C: Concurrent Chemoradiotherapy (cCRT)
Arm Description
Ociperlimab + tislelizumab + cCRT for 4 cycles followed by ociperlimab + tislelizumab
Tislelizumab + cCRT for 4 cycles followed by tislelizumab alone
cCRT for 4 cycles
Outcomes
Primary Outcome Measures
Progression free survival (PFS)
Determined from investigator derived tumor assessments per Response Evaluation Criteria in Solid Tumors (RECIST) v. 1.1.
Secondary Outcome Measures
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.
Duration of response (DOR)
Determined from investigator derived tumor assessments per Response Evaluation Criteria in Solid Tumors (RECIST) v. 1.1.
Overall Response Rate (ORR)
Determined from investigator derived tumor assessments per Response Evaluation Criteria in Solid Tumors (RECIST) v. 1.1.
Overall Survival (OS)
Determined from investigator derived tumor assessments per Response Evaluation Criteria in Solid Tumors (RECIST) v. 1.1.
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).
Distant metastasis-free survival (DMFS)
Determined from investigator derived tumor assessments per Response Evaluation Criteria in Solid Tumors (RECIST) v. 1.1.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04952597
Brief Title
Study of Ociperlimab Plus Tislelizumab Plus Chemoradiotherapy in Participants With Untreated Limited-Stage Small Cell Lung Cancer
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
July 15, 2021 (Actual)
Primary Completion Date
July 26, 2023 (Actual)
Study Completion Date
July 26, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
BeiGene
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Limited Stage Small Cell Lung Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
126 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arm A: Ociperlimab + Tislelizumab
Arm Type
Experimental
Arm Description
Ociperlimab + tislelizumab + cCRT for 4 cycles followed by ociperlimab + tislelizumab
Arm Title
Arm B: Tislelizumab
Arm Type
Experimental
Arm Description
Tislelizumab + cCRT for 4 cycles followed by tislelizumab alone
Arm Title
Arm C: Concurrent Chemoradiotherapy (cCRT)
Arm Type
Experimental
Arm Description
cCRT for 4 cycles
Intervention Type
Drug
Intervention Name(s)
Ociperlimab
Other Intervention Name(s)
BGB-A1217
Intervention Description
Ociperlimab is a monoclonal antibody formulated for intravenous injection.
Intervention Type
Drug
Intervention Name(s)
Tislelizumab
Other Intervention Name(s)
BGB-A317
Intervention Description
Tislelizumab is a monoclonal antibody formulated for intravenous injection.
Intervention Type
Drug
Intervention Name(s)
Concurrent Chemoradiotherapy
Intervention Description
Cisplatin / Carboplatin and Etoposide, intravenous therapy Radiotherapy
Primary Outcome Measure Information:
Title
Progression free survival (PFS)
Description
Determined from investigator derived tumor assessments per Response Evaluation Criteria in Solid Tumors (RECIST) v. 1.1.
Time Frame
30 months from First Patient In date
Secondary Outcome Measure Information:
Title
Complete Response (CR) rate as assessed by investigator per RECIST v1.1
Description
Determined from investigator derived tumor assessments per Response Evaluation Criteria in Solid Tumors (RECIST) v. 1.1.
Time Frame
30 months from First Patient In date
Title
Duration of response (DOR)
Description
Determined from investigator derived tumor assessments per Response Evaluation Criteria in Solid Tumors (RECIST) v. 1.1.
Time Frame
30 months from First Patient In date
Title
Overall Response Rate (ORR)
Description
Determined from investigator derived tumor assessments per Response Evaluation Criteria in Solid Tumors (RECIST) v. 1.1.
Time Frame
30 months from First Patient In date
Title
Overall Survival (OS)
Description
Determined from investigator derived tumor assessments per Response Evaluation Criteria in Solid Tumors (RECIST) v. 1.1.
Time Frame
30 months from First Patient In date
Title
Safety and tolerability: The incidence and severity of treatment-emergent adverse events (TEAEs)
Description
graded according to National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0 (NCI-CTCAE v5.0).
Time Frame
30 months from First Patient In date
Title
Distant metastasis-free survival (DMFS)
Description
Determined from investigator derived tumor assessments per Response Evaluation Criteria in Solid Tumors (RECIST) v. 1.1.
Time Frame
30 months from First Patient In date
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
You Lu
Organizational Affiliation
West China Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cancer Heartland Cancer Center
City
Garden City
State/Province
Kansas
ZIP/Postal Code
67846
Country
United States
Facility Name
XCancer Heartland Cancer Center
City
Garden City
State/Province
Kansas
ZIP/Postal Code
67846
Country
United States
Facility Name
Xcancer Tennesee Cancer Specialist
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37909
Country
United States
Facility Name
Tennesee Cancer Specialists
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37932
Country
United States
Facility Name
Beijing Cancer Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100142
Country
China
Facility Name
West China Hospital of Sichuan University
City
Sichuan
State/Province
Chengdu
Country
China
Facility Name
Gansu Cancer Hospital
City
Lanzhou
State/Province
Gansu
ZIP/Postal Code
730050
Country
China
Facility Name
The First Affiliated Hospital, Sun Yat-sen University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510080
Country
China
Facility Name
The People's Hospital of Guangxi Zhuang Autonomous Region
City
Nanning
State/Province
Guangxi
ZIP/Postal Code
530021
Country
China
Facility Name
Henan Cancer Hospital
City
Zhengzhou
State/Province
Henan
ZIP/Postal Code
450008
Country
China
Facility Name
First Affiliated Hospital of Zhengzhou University
City
Zhengzhou
State/Province
Henan
ZIP/Postal Code
450052
Country
China
Facility Name
Union Hospital of Tongji Medical College, Huazhong University of Science and Technology
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430022
Country
China
Facility Name
The Second Xiangya Hospital central South University
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410011
Country
China
Facility Name
The Second Xiangya Hospital of Central South University
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410011
Country
China
Facility Name
Huai'an First People's Hospital
City
Huai'an
State/Province
Jiangsu
ZIP/Postal Code
223002
Country
China
Facility Name
The Affiliated Hospital of Xuzhou Medical University
City
Xuzhou
State/Province
Jiangsu
ZIP/Postal Code
221002
Country
China
Facility Name
Qingdao Shandong Central Hospital
City
Shangdong
State/Province
Qingdao
ZIP/Postal Code
266031
Country
China
Facility Name
Qilu Hospital of Shandong University
City
Jinan
State/Province
Shandong
ZIP/Postal Code
250012
Country
China
Facility Name
Fudan University Shanghai Cancer Center
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
20000
Country
China
Facility Name
Fudan University Affiliated Zhongshan Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200032
Country
China
Facility Name
Hanzhong Central Hopital
City
Hanzhong
State/Province
Shanxi
ZIP/Postal Code
723000
Country
China
Facility Name
Mianyang Central Hospital
City
Mianyang
State/Province
Sichuan
ZIP/Postal Code
621000
Country
China
Facility Name
Tianjin Medical University General Hospital
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300052
Country
China
Facility Name
General Hospital of Tianjin Medical University
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300070
Country
China
Facility Name
Tianjin Medical University Cancer institute & Hospital
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300070
Country
China
Facility Name
The Second Affiliated Hospital of Kunming Medical University
City
Kunming
State/Province
Yunnan
ZIP/Postal Code
650000
Country
China
Facility Name
Sir Run Run Shaw Hospital Zhejiang University School of Medicine
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310000
Country
China
Facility Name
Zhejiang Cancer Hospital
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310022
Country
China
Facility Name
The First Affiliated Hospital, College of Medicine, Zhejiang University
City
Hangzhou
State/Province
Zhejiang
Country
China
Facility Name
Peking University First Hospital
City
Beijing
Country
China
Facility Name
Hunan Cancer Hospital
City
Changsha
ZIP/Postal Code
410013
Country
China
Facility Name
Changzhou Cancer Hospital
City
Changzhou
ZIP/Postal Code
213000
Country
China
Facility Name
Guangxi Medical University Affiliated Tumor Hospital
City
Guangxi
Country
China
Facility Name
The First Affiliated Hospital of Nanchang University
City
Nanchang
ZIP/Postal Code
330006
Country
China
Facility Name
Affiliated Hospital of North Sichuan medical College
City
Nanchong
ZIP/Postal Code
637000
Country
China
Facility Name
Nanjing Chest Hospital
City
Nanjing
ZIP/Postal Code
210029
Country
China
Facility Name
The People's Hospital of Guangxi Zhuang Autonomous Region
City
Nanning
ZIP/Postal Code
530021
Country
China
Facility Name
Linyi Cancer Hospital
City
Shandong
ZIP/Postal Code
276002
Country
China
Facility Name
Yantai Yuhuangding Hospital
City
Yantai
ZIP/Postal Code
264000
Country
China
Facility Name
Hwa Mei Hospital, University of Chinese Academy of Sciences
City
Zhejiang
Country
China
Facility Name
Henan Provincial People's Hospital
City
Zhengzhou
ZIP/Postal Code
450003
Country
China
Facility Name
Affiliated Hospital of Jiangsu University
City
Zhenjiang
ZIP/Postal Code
212001
Country
China
Facility Name
The Catholic University of Korea, Bucheon St. Mary's Hospital
City
Gyeonggi-do
State/Province
Bucheon-si
ZIP/Postal Code
14647
Country
Korea, Republic of
Facility Name
Kyungpook National University Chilgok Hospital
City
Daegu
State/Province
Buk-gu
ZIP/Postal Code
41404
Country
Korea, Republic of
Facility Name
Chungbuk National University Hospital
City
Cheongju-si
State/Province
Chungcheongbuk-do
ZIP/Postal Code
28644
Country
Korea, Republic of
Facility Name
The Catholic University of Korea Eunpyeong St. Mary's Hospital
City
Seoul
State/Province
Eunpyeong-gu
ZIP/Postal Code
03312
Country
Korea, Republic of
Facility Name
The Catholic University of Korea - St. Vincent's Hospital
City
Suwon
State/Province
Gyeonggi-do
ZIP/Postal Code
16247
Country
Korea, Republic of
Facility Name
SMG-SNU Boramae Medical Center - Oncology
City
Seoul
State/Province
Seoul Teugbyeolsi [Seoul-T'ukp
ZIP/Postal Code
07061
Country
Korea, Republic of
Facility Name
Ajou University Hospital
City
Gyeonggi-do
Country
Korea, Republic of
Facility Name
The Catholic University of Korea - Seoul St. Mary's Hospital (Kangnam St. Mary's Hospital)
City
Seoul
ZIP/Postal Code
06591
Country
Korea, Republic of
Facility Name
The Catholic University of Korea - St. Vincent's Hospital - Lung Cancer Center
City
Seoul
ZIP/Postal Code
16247
Country
Korea, Republic of
Facility Name
Ulsan University Hospital
City
Ulsan
ZIP/Postal Code
44033
Country
Korea, Republic of
12. IPD Sharing Statement
Plan to Share IPD
Yes
Learn more about this trial
Study of Ociperlimab Plus Tislelizumab Plus Chemoradiotherapy in Participants With Untreated Limited-Stage Small Cell Lung Cancer
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