Lung Cancer Clinical Trial

Ociperlimab With Tislelizumab and Chemotherapy in Patients With Untreated Metastatic Non-Small Cell Lung Cancer

Summary

This is a randomized investigator and patient 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

View Eligibility Criteria

Eligibility Criteria

Key Inclusion Criteria:

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. Patients 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 patients who have evaluable PD-L1 results are eligible.

At least one measurable lesion by the investigator per RECIST v1.1.

.

Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 1.

Key Exclusion Criteria:

Known mutations in:

EGFR gene Note: For non-squamous NSCLC, patients 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. Patients found to have EGFR-sensitizing mutations will be excluded.
ALK fusion oncogene.
BRAF V600E
ROS1
Prior treatment with EGFR inhibitors, ALK inhibitors, or targeted therapy for other driver mutations.
Any prior therapy targeting T-cell costimulation or checkpoint pathways in metastatic NSCLC.
Any condition that required systemic treatment with either corticosteroids (> 10 mg daily of prednisone or equivalent) or other immunosuppressive medication ≤ 14 days before randomization.
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 is for people with:

Lung Cancer

Phase:

Phase 2

Estimated Enrollment:

270

Study ID:

NCT05014815

Recruitment Status:

Recruiting

Sponsor:

BeiGene

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There are 77 Locations for this study

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Valkyrie Clinical Trials
Los Angeles California, 90067, United States
University of Iowa Hospitals and Clinics
Iowa City Iowa, 52242, United States
Comprehensive Cancer Center of Nevada
Henderson Nevada, 89074, United States
Northwell Health-Monter Cancer Center
Lake Success New York, 11040, United States
Ny Cancer And Blood Specialists
Port Jefferson Station New York, 11776, United States
University of North Carolina at Chapel Hill
Chapel Hill North Carolina, 27514, United States
Xcancer_Dayton Physician Network
Dayton Ohio, 45409, United States
Tennessee Cancer Specialist
Knoxville Tennessee, 37909, United States
Texas Oncology (Tyler) - USOR
Tyler Texas, 75702, United States
Cancer Care Northwest
Spokane Valley Washington, 99216, United States
Northern Beaches Hospital
Frenchs Forest New South Wales, 2086, Australia
Port Macquarie Base Hospital
Port Macquarie, New South Wales, 2444, Australia
Townsville University Hospital
Douglas Queensland, 4814, Australia
Toowoomba Hospital
Toowoomba Queensland, 4350, Australia
Launceston general hospital
Launceston Tasmania, 7250, Australia
Peninsula & South Eastern Hematology and Oncology Group
Frankston Victoria, 3199, Australia
Olivia Newton-John Cancer Wellness & Research Centre
Heidelberg Victoria, 3084, Australia
Border Medical Oncology
Wodonga Victoria, , Australia
Universitätsklinikum Krems
Krems Krems An Der Donau, 3500, Austria
Klinikum Klagenfurt am Wörthersee
Klagenfurt Wörthersee, 9020, Austria
Universitätsklinik für Innere Medizin III, mit Hämatologie, internistischer Onkologie, Hämostaseologie, Infektiologie, Rheumatologie und Onkologisches Zentrum
Salzburg , 5020, Austria
Klinik Penzing - Wiener Gesundheitsverband
Wien , 1140, Austria
China-Japan Friendship Hospital
Beijing Beijing, 10002, China
Beijing Cancer Hospital
Beijing Beijing, 10014, China
The second Affiliated Hospital of Chongqing Medical University
Chongqing Chongqing, 40001, China
Xin Qiao Hospital Affiliated to The Army Medical University
Chongqing Chongqing, 40037, China
Army Medical Center of PLA
Chongqing Chongqing, 40042, China
Fujian Cancer Hospital
Fujian Fujian, , China
First Hospital of Lanzhou University
Lanzhou Gansu, 73000, China
Cancer Center of Guangzhou Medical University
Guangzhou Guangdong, 51005, China
Affiliated Tumor Hospital of Harbin Medical University
Harbin Heilongjiang, 10014, China
First Affiliated Hospital of Zhengzhou University
Zhengzhou Henan, 45005, China
Jingzhou Central Hospital
Jingzhou Hubei, 43402, China
Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology
Wuhan Hubei, 43007, China
Chenzhou First People's Hospital
Chenzhou Hunan, 42309, China
Changzhou Cancer Hospital
Changzhou Jiangsu, 21300, China
Ansteel Group General Hospital
Anshan Liaoning, 11400, China
Shandong Cancer Hospital
Jinan Shandong, 25011, China
Liaocheng People's Hospital
Liaocheng Shandong, 25200, China
Fudan university Shanghai Cancer Center
Shanghai Shanghai, 20003, China
Huashan hospital affiliated to Fudan University
Shanghai Shanghai, 20004, China
Shanghai Pulmonary Hospital
Shanghai Shanghai, 20043, China
West China Hospital ,Sichuan University
Chengdu Sichuan, 61004, China
The First People's Hospital of Kashgar
Kashgar Xinjiang, 84409, China
First Affiliated Hospital, School of Medicine, Shihezi University
Shihezi Xinjiang, 83209, China
Zhejiang Provincial People's Hospital
Hangzhou Zhejiang, 31001, China
Zhejiang Cancer Hospital
Hangzhou Zhejiang, 31002, China
Huzhou Central Hospital
Huzhou Zhejiang, 3100, China
The First Hospital of Jiaxing
Jiaxing Zhejiang, 31400, China
Jinhua Municipal Central Hospital
Jinhua Zhejiang, 32100, China
Hôpital Européen Georges Pompidou
Paris Cedex, 75098, France
Hopital Charles Nicolle - Centre Hospitalier Universitaire de Rouen
Rouen Cedex, 76031, France
Institut Curie
Paris , 75005, France
Gangnam Severance Hospital, Yonsei University Health System
Seoul Gangnam-Gu, 06273, Korea, Republic of
Dong-A University Hospital
Busan , 49201, Korea, Republic of
CHA Bundang Medical Center, CHA University
Gyeonggi-do , 13496, Korea, Republic of
Ajou University Hospital
Gyeonggi-do , 16499, Korea, Republic of
Seoul National University Hospital
Seoul , 03080, Korea, Republic of
Kangbuk Samsung Hospital
Seoul , 03181, Korea, Republic of
Severance Hospital, Yonsei University Health System
Seoul , 03722, Korea, Republic of
Samsung Medical Center
Seoul , 06351, Korea, Republic of
Korea University Guro Hospital
Seoul , 08308, Korea, Republic of
Ulsan University Hospital
Ulsan , 44033, Korea, Republic of
Wojewodzki Szpital Zespolony IM. L. Rydygiera W Toruniu
Torun , 87-10, Poland
Narodowky Instytut Onkologii Marii Sklodowskiej-Curie
Warsaw , 02-78, Poland
Hospital Universitario Central de Asturias
Oviedo Austrias, 33011, Spain
Hospital Clinic de Barcelona
Barcelona Catalunya, 08036, Spain
Consorcio Hospitalario Provincial de Castellón
Castillón Comunidad De Valencia, 50009, Spain
Instituto Valenciano de Oncologia-IVO
Valencia Comunidad De Valencia, 46009, Spain
Hospital Universitario de León
León Leon, 24071, Spain
Centro Oncológico de Galicia
A Coruña , 15009, Spain
Hospital General Universitario Gregorio Marañon
Madrid , 28009, Spain
Clinica Universitaria de Navarra, Madrid
Madrid , 28027, Spain
MD Anderson Cancer Center - Madrid
Madrid , 28033, Spain
Clinica Universitaria de Navarra Pamplona
Pamplona , 31008, Spain
Acibadem Atakent Hospital
Küçükçekmece, Istanbul, 34303, Turkey
Adana City Education and Research Hospital
Adana , 01060, Turkey
ASV Yassam Hospital
Antalya , 07300, Turkey
Acibadem Maslak Hospital
Istanbul , 34457, Turkey
Marmara University Pendik Research and Training Hospital
Pendik , 34809, Turkey

How clear is this clinincal trial information?

Study is for people with:

Lung Cancer

Phase:

Phase 2

Estimated Enrollment:

270

Study ID:

NCT05014815

Recruitment Status:

Recruiting

Sponsor:


BeiGene

How clear is this clinincal trial information?

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