Study Stopped
This decision was conducted by the sponsor and not driven by safety concerns as no new safety signals have been observed in the ociperlimab program.
A Study to Compare Ociperlimab Plus Tislelizumab Versus Durvalumab Following Concurrent Chemoradiotherapy (cCRT) in Participants With Stage III Unresectable Non-Small Cell Lung Cancer
A Phase 3, Randomized, Open-Label Study to Compare Ociperlimab (BGB-A1217) Plus Tislelizumab (BGB-A317) Versus Durvalumab in Patients With Locally Advanced, Unresectable, PD-L1-Selected Non-Small Cell Lung Cancer Whose Disease Has Not Progressed After Concurrent Chemoradiotherapy
3 other identifiers
interventional
63
5 countries
35
Brief Summary
The purpose of this study was to evaluate the safety and efficacy of ociperlimab in combination with tislelizumab compared to durvalumab in adults with stage III unresectable PD-L1-selected non-small cell lung cancer whose disease has not progressed after cCRT.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Jun 2021
35 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 28, 2020
CompletedFirst Posted
Study publicly available on registry
April 29, 2021
CompletedStudy Start
First participant enrolled
June 17, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 17, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
October 17, 2023
CompletedResults Posted
Study results publicly available
October 31, 2024
CompletedOctober 31, 2024
October 1, 2024
2.3 years
October 28, 2020
October 9, 2024
October 9, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Progression-Free Survival (PFS) as Assessed by the Independent Review Committee (IRC)
PFS is defined as the time from the date of randomization to the date of first documentation of disease progression as assessed by the IRC per Response Evaluation Criteria in Solid Tumors (RECIST) Version (v) 1.1 or death, whichever occurred first.
From randomization through to the end of study, planned duration was 20 months
Secondary Outcomes (15)
Overall Survival (OS)
From randomization through to the end of study, planned duration was 20 months
Overall Response Rate (ORR)
From randomization through to the end of study, planned duration was 20 months
Duration of Response (DOR)
From randomization through to the end of study, planned duration was 20 months
Time to Death or Distant Metastasis (TTDM) as Assessed by the Investigator
From randomization through to the end of study, planned duration was 20 months
Progression-Free Survival 2 (PFS2)
From randomization through to the end of study, planned duration was 20 months
- +10 more secondary outcomes
Study Arms (3)
Ociperlimab + Tislelizumab + cCRT
EXPERIMENTALParticipants enrolled under PA1 recieved two cycles of ociperlimab combined with tislelizumab and cCRT, followed by ociperlimab combined with tislelizumab up to 1 year after the cCRT phase
Tislelizumab + cCRT
EXPERIMENTALParticipants enrolled under PA1 recieved two cycles of tislelizumab combined with cCRT, followed by tislelizumab up to 1 year after the cCRT phase
cCRT followed by Durvalumab
EXPERIMENTALParticipants enrolled under PA1 recieved two cycles of cCRT, followed by durvalumab to 1 year after the cCRT phase
Interventions
200 mg intravenously every three weeks
10 milligrams per kilogram (mg/kg) intravenously once every 2 weeks (or 1500 mg intravenously once every 4 weeks where the dosage has been approved by a local health authority)
900 milligrams (mg) intravenously every three weeks
The chemotherapy regimen for the study treatment was selected at the investigator's discretion and may include one of the following options: * Cisplatin (50 mg/m²) on days 1 to 5 of each cycle, combined with etoposide (50 mg/m²) on days 1 and 8, both administered intravenously for 2 cycles. Each cycle was 28 days. * Carboplatin (AUC 2) weekly for 6 weeks, combined with paclitaxel (40-50 mg/m²) weekly for 6 weeks, both administered intravenously. * Cisplatin (75 mg/m²) combined with pemetrexed (500 mg/m²) on day 1 of each cycle, administered intravenously for 2 cycles. Each cycle was 21 days. * Carboplatin (AUC 5) combined with pemetrexed (500 mg/m²) on day 1 of each cycle, administered intravenously for 2 cycles. Each cycle was 21 days. The pemetrexed plus platinum regimen was only for participants with non-squamous histology.
All participants recieved radiotherapy using either a standardized 3-dimensional conformal radiotherapy technique, or intensity modulated radiotherapy (IMRT) on a linear accelerator delivering a beam energy of ≥ 6 MV. The total dose of radiotherapy was 60 Gy, administered in 30 once-daily fractions of 2 Gy and 5 fractions per week for 6 weeks.
Eligibility Criteria
You may qualify if:
- Age ≥ 18 years on the day of signing the informed consent form (or the legal age of consent in the jurisdiction in which the study is taking place).
- Participant has histologically or cytologically confirmed, locally advanced, unresectable Stage III NSCLC (AJCC Cancer Staging Manual 2017, derived from IASLC) prior to initiation of cCRT.
- Participant must have completed at least 2 cycles of platinum-based chemotherapy concurrent with radiotherapy
- Participants must have not experienced PD following definitive, platinum-based cCRT.
- Eastern Co-operative Oncology Group (ECOG) Performance Status of 0 or 1.
- Participants must have adequate organ function
- Agree to provide archival tissue (formalin-fixed paraffin-embedded block containing tumor \[preferred\] or approximately 6 to 15 freshly cut unstained slides) or fresh biopsy obtained prior to cCRT (if archival tissue is not available) for prospective central evaluation of PD-L1 levels and retrospective analysis of other biomarkers.
You may not qualify if:
- Prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2, TIGIT, or any other antibody or drugs specifically targeting T-cell co-stimulation or checkpoint pathways.
- Diagnosed with NSCLC that harbors an epidermal growth factor receptor (EGFR) sensitizing mutation, anaplastic lymphoma kinase (ALK) gene translocation, ROS1 gene translocation or RET gene rearrangement.
- Participants who received systemic anticancer treatment besides the specified cCRT.
- Any unresolved toxicity CTCAE \> Grade 2 from the prior cCRT.
- Active autoimmune diseases or history of autoimmune diseases that may relapse.
- Any condition that required systemic treatment with either corticosteroids (\> 10 mg daily of prednisone \[in Japan, prednisolone\] or equivalent) or other immunosuppressive medication ≤ 14 days before the first dose of study treatment.
- Infection (including tuberculosis infection, etc) requiring systemic antibacterial, antifungal, or antiviral therapy within 14 days before the first dose of study treatment.
- Note: Antiviral therapy is permitted for participants with chronic hepatitis B virus (HBV) or hepatitis C virus (HCV) infection.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- BeiGenelead
Study Sites (35)
XCancer/Centeral Care Center
Bolivar, Missouri, 65613, United States
Southern Medical Day Care Centre
Wollongong, New South Wales, NSW 2500, Australia
Townsville Hospital
Douglas, Queensland, 4814, Australia
Lyell McEwin Hospital
Elizabeth Vale, South Australia, 5112, Australia
Royal Hobart Hospital
Hobart, Tasmania, Australia
Cabrini Hospital
Malvern, Victoria, 3144, Australia
Gold Coast University Hospital
Gold Coast, 4215, Australia
Hollywood Private Hospital
Perth, Australia
Beijing Cancer Hospital
Beijing, Beijing Municipality, 100142, China
Chongqing University Cancer Hospital
Chongqing, Chongqing Municipality, 400030, China
Fujian Cancer Hospital
Fuzhou, Fujian, 350014, China
Nanfang Hospital of Southern Medical University
Guangzhou, Guangdong, 510515, China
The First Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China
Hunan Cancer Hospital - GCP Office
Changsha, Hunan, 410013, China
Nanjing First Hospital
Nanjing, Jiangsu, 210009, China
The First Affiliated Hospital of Soochow University Branch Shizi
Suzhou, Jiangsu, 215006, China
The First Affiliated Hospital of Nanchang University Branch Donghu
Nanchang, Jiangxi, 330006, China
Jilin Cancer Hospital
Changchun, Jilin, 130021, China
The First Hospital of Jilin University
Changchun, Jilin, 130021, China
General Hospital of Ningxia Medical University
Yinchuan, Ningxia, 750004, China
Shandong Cancer Hospital and Institute, Shandong First Medical University
Jinan, Shandong, 250117, China
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200000, China
West China Hospital, Sichuan University
Chengdu, Sichuan, 610041, China
Tianjin Medical University Cancer Institute & Hospital
Tianjin, Tianjin Municipality, 300060, China
Sir Run Run Shaw Hospital, Zhejiang University, School of Medicine
Hangzhou, Zhejiang, 310016, China
Peking University Third Hospital
Beijing, China
Changzhou Cancer Hospital
Changzhou, 213000, China
Jieyang People'S Hospital (Jieyang Affiliated Hospital, Sun Yat-Sen University )
Jieyang, 522091, China
Hospital Universitario Fundación Jiménez Díaz
Alcorcón, Madrid, 28040, Spain
Instituto Oncologico Dr. Rosell
Barcelona, 08028, Spain
Ico Girona
Girona, 17007, Spain
Changhua Christian Hospital
Changhua, 50006, Taiwan
Chung Shan Medical University Hospital
Taichung, 40201, Taiwan
Taichung Veterans General Hospital
Taichung, Taiwan
Taipei Veterans General Hospital
Taipei, 11217, Taiwan
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
Since no participants were enrolled under PA 2, no analyses of the primary or secondary endpoints were conducted. Participants enrolled under PA 1 were excluded from the primary and secondary analyses outlined for PA 2.
Results Point of Contact
- Title
- Study Director
- Organization
- BeiGene
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 28, 2020
First Posted
April 29, 2021
Study Start
June 17, 2021
Primary Completion
October 17, 2023
Study Completion
October 17, 2023
Last Updated
October 31, 2024
Results First Posted
October 31, 2024
Record last verified: 2024-10
Data Sharing
- IPD Sharing
- Will share