Ociperlimab With Tislelizumab and Chemotherapy in Participants With Untreated Metastatic Non-Small Cell Lung Cancer
- Conditions
- Locally Advanced, Unresectable, or Metastatic Nonsmall Cell Lung Cancer (NSCLC)Nonsmall Cell Lung Cancer, Stage IV
- Interventions
- Registration Number
- NCT05014815
- Lead Sponsor
- BeiGene
- Brief Summary
This is a randomized investigator and participant blinded, sponsor unblinded, multicenter study that evaluates the safety and efficacy of ociperlimab with tislelizumab and histology-based chemotherapy compared with treatment with tislelizumab and histology-based chemotherapy in participants with previously untreated locally advanced, unresectable, or metastatic NSCLC
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 272
-
Histologically or cytologically documented locally advanced or recurrent NSCLC that is not eligible for curative surgery and/or definitive radiotherapy, with or without chemotherapy, or metastatic non-squamous or squamous NSCLC.
-
No prior systemic therapy for locally advanced or metastatic squamous or non-squamous NSCLC, including but not limited to chemotherapy or targeted therapy. Participants who have received prior neoadjuvant, adjuvant chemotherapy, or chemoradiotherapy with curative intent for nonmetastatic disease must have experienced a disease-free interval of ≥ 6 months from the last dose of chemotherapy and/or concurrent radiotherapy prior to randomization.
-
Archival tumor tissue or fresh biopsy (if archival tissue is not available) for the determination of PD-L1 levels and retrospective analyses of other biomarkers. Only participantswho have evaluable PD-L1 results are eligible.
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At least one measurable lesion by the investigator per RECIST v1.1.
.
-
Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 1.
Key
-
Known mutations in:
- EGFR gene Note: For non-squamous NSCLC, articipants with unknown EGFR mutation status will be required to have a tissue-based EGFR test either locally or at the central laboratory before enrollment, or endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA)-based EGFR test locally. Participants found to have EGFR-sensitizing mutations will be excluded.
- ALK fusion oncogene.
- BRAF V600E
- ROS1
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Prior treatment with EGFR inhibitors, ALK inhibitors, or targeted therapy for other driver mutations.
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Any prior therapy targeting T-cell costimulation or checkpoint pathways in metastatic NSCLC.
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Any condition that required systemic treatment with either corticosteroids (> 10 mg daily of prednisone or equivalent) or other immunosuppressive medication ≤ 14 days before randomization.
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Infection (including tuberculosis infection, etc.) requiring systemic antibacterial, antifungal, or antiviral therapy within 14 days before randomization.
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm A: Ociperlimab + tislelizumab histology-based chemotherapy Ociperlimab - Arm A: Ociperlimab + tislelizumab histology-based chemotherapy Tislelizumab - Arm A: Ociperlimab + tislelizumab histology-based chemotherapy histology-based chemotherapy - Arm B: Placebo + tislelizumab + histology-based chemotherapy Tislelizumab - Arm B: Placebo + tislelizumab + histology-based chemotherapy histology-based chemotherapy - Arm B: Placebo + tislelizumab + histology-based chemotherapy Placebo -
- Primary Outcome Measures
Name Time Method Progression-free Survival (PFS) as Assessed by Investigators Up to approximately 30 months PFS will be defined as the time from the date of randomization to the date of the first objectively documented tumor progression per RECIST v1.1, or death, whichever occurs first
- Secondary Outcome Measures
Name Time Method Overall Response Rate (ORR) as Assessed by Investigators Up to approximately 30 months ORR will be defined as the proportion of participants with a documented, confirmed complete response or partial response per RECIST v1.1.
Duration of Response (DoR) As Assessed by Investigators Up to approximately 30 months DOR is defined as the time from the first determination of an objective response (OR) per RECIST v1.1 until the first documentation of progression.
Overall Survival (OS) Up to approximately 30 months OS will be defined as the time from the date of randomization to the date of death due to any cause.
Number of Participants Experiencing Adverse Events (AEs) 90 days (±14) after last dose The incidence and severity of AEs will be determined according to National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0 (NCI CTCAE v5.0).
Trial Locations
- Locations (76)
Port Macquarie Base Hospital
🇦🇺Port Macquarie, New South Wales, Australia
Universitätsklinikum Krems
🇦🇹Krems, Krems an der Donau, Austria
University of Iowa Hospitals and Clinics
🇺🇸Iowa City, Iowa, United States
Valkyrie Clinical Trials
🇺🇸Los Angeles, California, United States
Comprehensive Cancer Center of Nevada
🇺🇸Henderson, Nevada, United States
Northwell Health-Monter Cancer Center
🇺🇸Lake Success, New York, United States
Xcancer_Dayton Physician Network
🇺🇸Dayton, Ohio, United States
Cancer Care Northwest
🇺🇸Spokane Valley, Washington, United States
Tennessee Cancer Specialist
🇺🇸Knoxville, Tennessee, United States
Northern Beaches Hospital
🇦🇺Frenchs Forest, New South Wales, Australia
Townsville University Hospital
🇦🇺Douglas, Queensland, Australia
Peninsula & South Eastern Hematology and Oncology Group
🇦🇺Frankston, Victoria, Australia
Toowoomba Hospital
🇦🇺Toowoomba, Queensland, Australia
Olivia Newton-John Cancer Wellness & Research Centre
🇦🇺Heidelberg, Victoria, Australia
Beijing Cancer Hospital
🇨🇳Beijing, Beijing, China
China-Japan Friendship Hospital
🇨🇳Beijing, Beijing, China
Xin Qiao Hospital Affiliated to The Army Medical University
🇨🇳Chongqing, Chongqing, China
Fujian Cancer Hospital
🇨🇳Fujian, Fujian, China
Army Medical Center of PLA
🇨🇳Chongqing, Chongqing, China
First Hospital of Lanzhou University
🇨🇳Lanzhou, Gansu, China
Affiliated Tumor Hospital of Harbin Medical University
🇨🇳Harbin, Heilongjiang, China
Jingzhou Central Hospital
🇨🇳Jingzhou, Hubei, China
First Affiliated Hospital of Zhengzhou University
🇨🇳Zhengzhou, Henan, China
Cancer Center of Guangzhou Medical University
🇨🇳Guangzhou, Guangdong, China
Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology
🇨🇳Wuhan, Hubei, China
Chenzhou First People's Hospital
🇨🇳Chenzhou, Hunan, China
Changzhou Cancer Hospital
🇨🇳Changzhou, Jiangsu, China
Ansteel Group General Hospital
🇨🇳Anshan, Liaoning, China
Shandong Cancer Hospital
🇨🇳Jinan, Shandong, China
Liaocheng People's Hospital
🇨🇳Liaocheng, Shandong, China
Fudan university Shanghai Cancer Center
🇨🇳Shanghai, Shanghai, China
Shanghai Pulmonary Hospital
🇨🇳Shanghai, Shanghai, China
First Affiliated Hospital, School of Medicine, Shihezi University
🇨🇳Shihezi, Xinjiang, China
Zhejiang Provincial People's Hospital
🇨🇳Hangzhou, Zhejiang, China
West China Hospital ,Sichuan University
🇨🇳Chengdu, Sichuan, China
Huashan hospital affiliated to Fudan University
🇨🇳Shanghai, Shanghai, China
The First People's Hospital of Kashgar
🇨🇳Kashgar, Xinjiang, China
Zhejiang Cancer Hospital
🇨🇳Hangzhou, Zhejiang, China
The First Hospital of Jiaxing
🇨🇳Jiaxing, Zhejiang, China
Institut Curie
🇫🇷Paris, France
Huzhou Central Hospital
🇨🇳Huzhou, Zhejiang, China
Hôpital Européen Georges Pompidou
🇫🇷Paris, Cedex, France
Jinhua Municipal Central Hospital
🇨🇳Jinhua, Zhejiang, China
Hopital Charles Nicolle - Centre Hospitalier Universitaire de Rouen
🇫🇷Rouen, Cedex, France
Dong-A University Hospital
🇰🇷Busan, Korea, Republic of
CHA Bundang Medical Center, CHA University
🇰🇷Gyeonggi-do, Korea, Republic of
Gangnam Severance Hospital, Yonsei University Health System
🇰🇷Seoul, Gangnam-Gu, Korea, Republic of
Ajou University Hospital
🇰🇷Gyeonggi-do, Korea, Republic of
Kangbuk Samsung Hospital
🇰🇷Seoul, Korea, Republic of
Hospital Universitario Central de Asturias
🇪🇸Oviedo, Austrias, Spain
Samsung Medical Center
🇰🇷Seoul, Korea, Republic of
Ulsan University Hospital
🇰🇷Ulsan, Korea, Republic of
Centro Oncológico de Galicia
🇪🇸A Coruña, Spain
Instituto Valenciano de Oncologia-IVO
🇪🇸Valencia, Comunidad De Valencia, Spain
Hospital Universitario de León
🇪🇸León, Leon, Spain
Consorcio Hospitalario Provincial de Castellón
🇪🇸Castillón, Comunidad De Valencia, Spain
Seoul National University Hospital
🇰🇷Seoul, Korea, Republic of
Severance Hospital, Yonsei University Health System
🇰🇷Seoul, Korea, Republic of
Korea University Guro Hospital
🇰🇷Seoul, Korea, Republic of
MD Anderson Cancer Center - Madrid
🇪🇸Madrid, Spain
Texas Oncology (Tyler) - USOR
🇺🇸Tyler, Texas, United States
Ny Cancer and Blood Specialists
🇺🇸Bronx, New York, United States
Rj Zuckerberg Cancer Center
🇺🇸Lake Success, New York, United States
North Shore Hematology Oncology Associates Dba New York Cancer and Blood Specialists (New York)
🇺🇸New York, New York, United States
North Shore Hematology Oncology Associates Dba New York Cancer and Blood Specialists
🇺🇸Port Jefferson Station, New York, United States
University of North Carolina At Chapel Hill
🇺🇸Chapel Hill, North Carolina, United States
Xcancerdayton Physician Network
🇺🇸Dayton, Ohio, United States
Texas Oncology Tyler Longview
🇺🇸Tyler, Texas, United States
Border Medical Oncology
🇦🇺East Albury, New South Wales, Australia
Darling Downs Hospital and Health Service Toowoomba Hospital
🇦🇺Toowoomba, Queensland, Australia
Launceston General Hospital
🇦🇺Launceston, Tasmania, Australia
Peninsula and South Eastern Haematology and Oncology Group
🇦🇺Frankston, Victoria, Australia
Olivia Newton John Cancer Wellness and Research Centre
🇦🇺Heidelberg, Victoria, Australia
Klinik Penzing Wien, Abteilung Fur Atemwegs
🇦🇹Vienna, Austria
Xinqiao Hospital Affiliated to the Army Medical University
🇨🇳Chongqing, Chongqing, China
Daping Hospital, Third Military Medical University
🇨🇳Chongqing, Chongqing, China