Ociperlimab With Tislelizumab and Chemotherapy in Participants With Untreated Metastatic Non-Small Cell Lung Cancer
NCT ID: NCT05014815
Last Updated: 2025-09-16
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
272 participants
INTERVENTIONAL
2021-11-16
2024-09-04
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Arm A (O+T+C)
During the induction phase, participants received ociperlimab (O) 900 mg IV, tislelizumab (T) 200 mg IV, and histology-based chemotherapy (C) every 21 days for 4-6 cycles. For squamous NSCLC, chemotherapy included carboplatin AUC 5 or 6 (on Day 1) + paclitaxel 175 or 200 mg/m² (Day 1) or nab-paclitaxel 100 mg/m² (Days 1, 8, 15) every 3 weeks. For non-squamous NSCLC, chemotherapy included cisplatin 75 mg/m² or carboplatin AUC 5 (Day 1) + pemetrexed (P) 500 mg/m² IV (Day 1), every 3 weeks.
In the maintenance phase, non-squamous NSCLC participants received O 900 mg IV, T 200 mg IV, and pemetrexed 500 mg/m² IV every 3 weeks. Squamous NSCLC participants received O 900 mg IV and T 200 mg IV every 3 weeks until toxicity, consent withdrawal, or investigator-determined lack of benefit.
Ociperlimab
900 mg intravenously (IV) once every 3 weeks (Q3W)
Tislelizumab
200 mg IV Q3W
Carboplatin
Area under the concentration-time curve (AUC) of 5 or 6, administered on Day 1 of each 21-day cycle
Paclitaxel
75 or 200 mg per square meter (mg/m²) of body surface area, administered on Day 1 of each 21-day cycle
Nab paclitaxel
100 mg/m², administered intravenously on Days 1, 8, and 15 of each 21-day cycle
Cisplatin
75 mg/m², administered intravenously on Day 1 of each 21-day cycle
Pemetrexed
500 mg/m² administered intravenously on Day 1 of each 21-day cycle
Arm B (P+T+C)
During the induction phase, participants received placebo (P) 900 mg IV, tislelizumab (T) 200 mg IV, and histology-based chemotherapy (C) every 21 days for 4-6 cycles. For squamous NSCLC, chemotherapy included carboplatin AUC 5 or 6 (Day 1) + paclitaxel 175 or 200 mg/m² (Day 1) or nab-paclitaxel 100 mg/m² (Days 1, 8, 15) every 3 weeks. For non-squamous NSCLC, chemotherapy included cisplatin 75 mg/m² or carboplatin AUC 5 (Day 1) + pemetrexed (P) 500 mg/m² IV (Day 1), every 3 weeks.
In the maintenance phase, non-squamous NSCLC participants received placebo 900 mg IV, T 200 mg IV, and pemetrexed 500 mg/m² IV every 3 weeks. Squamous NSCLC participants received placebo IV and T 200 mg IV every 3 weeks until toxicity, consent withdrawal, or investigator-determined lack of benefit.
Tislelizumab
200 mg IV Q3W
Carboplatin
Area under the concentration-time curve (AUC) of 5 or 6, administered on Day 1 of each 21-day cycle
Paclitaxel
75 or 200 mg per square meter (mg/m²) of body surface area, administered on Day 1 of each 21-day cycle
Nab paclitaxel
100 mg/m², administered intravenously on Days 1, 8, and 15 of each 21-day cycle
Cisplatin
75 mg/m², administered intravenously on Day 1 of each 21-day cycle
Pemetrexed
500 mg/m² administered intravenously on Day 1 of each 21-day cycle
Placebo
Administered intravenously Q3W to match ociperlimab
Interventions
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Ociperlimab
900 mg intravenously (IV) once every 3 weeks (Q3W)
Tislelizumab
200 mg IV Q3W
Carboplatin
Area under the concentration-time curve (AUC) of 5 or 6, administered on Day 1 of each 21-day cycle
Paclitaxel
75 or 200 mg per square meter (mg/m²) of body surface area, administered on Day 1 of each 21-day cycle
Nab paclitaxel
100 mg/m², administered intravenously on Days 1, 8, and 15 of each 21-day cycle
Cisplatin
75 mg/m², administered intravenously on Day 1 of each 21-day cycle
Pemetrexed
500 mg/m² administered intravenously on Day 1 of each 21-day cycle
Placebo
Administered intravenously Q3W to match ociperlimab
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Participants had not received any prior systemic therapy for locally advanced or metastatic squamous or non-squamous NSCLC, including but not limited to chemotherapy or targeted therapies. Those who had previously received neoadjuvant or adjuvant chemotherapy, or chemoradiotherapy with curative intent for non-metastatic disease, were required to have experienced a disease-free interval of at least 6 months from the last dose of chemotherapy and/or concurrent radiotherapy prior to randomization.
3. Archival tumor tissue or a fresh biopsy (if archival tissue was unavailable) was required for programmed death-ligand 1 (PD-L1) level assessment and retrospective biomarker analyses. Only participants with evaluable PD-L1 results were considered eligible.
4. Participants were required to have had at least one measurable lesion as assessed by the investigator in accordance with the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
5. Participants had an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.
Exclusion Criteria
* Epidermal Growth Factor Receptor (EGFR): For participants with non-squamous NSCLC and unknown EGFR mutation status, tissue-based EGFR testing (performed either locally or at a central laboratory) or an endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA)-based EGFR test was required prior to enrollment. Those found to harbor EGFR-sensitizing mutations were excluded.
* Anaplastic Lymphoma Kinase (ALK) fusion oncogene.
* B-Raf Proto-Oncogene (BRAF) V600E mutation.
* ROS Proto-Oncogene 1 (ROS1) rearrangement.
2. Participants who had received prior treatment with EGFR inhibitors, ALK inhibitors, or other targeted therapies for known driver mutations.
3. Participants who had received any prior therapies targeting T-cell costimulatory or checkpoint pathways (e.g., programmed cell death protein 1 \[PD-1\], programmed death-ligand 1 \[PD-L1\], or cytotoxic T-lymphocyte-associated protein 4 \[CTLA-4\]) for metastatic NSCLC were excluded.
4. Participants who had any condition requiring systemic treatment with corticosteroids at a dose greater than 10 mg of prednisone (or equivalent) daily, or other immunosuppressive medications within 14 days prior to randomization.
5. Participants who had an active infection, including but not limited to tuberculosis, requiring systemic antibacterial, antifungal, or antiviral treatment within 14 days prior to randomization were excluded.
18 Years
ALL
No
Sponsors
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BeiGene
INDUSTRY
Responsible Party
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Locations
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Valkyrie Clinical Trials
Los Angeles, California, United States
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States
Comprehensive Cancer Center of Nevada
Las Vegas, Nevada, United States
Rj Zuckerberg Cancer Center
New Hyde Park, 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
Ny Cancer and Blood Specialists
The Bronx, New York, United States
Xcancerdayton Physician Network
Dayton, Ohio, United States
Tennessee Cancer Specialist
Knoxville, Tennessee, United States
Texas Oncology Tyler Longview
Austin, Texas, United States
Cancer Care Northwest
Spokane Valley, Washington, United States
Border Medical Oncology
East Albury, New South Wales, Australia
Northern Beaches Hospital
Frenchs Forest, New South Wales, Australia
Port Macquarie Base Hospital
Port Macquarie, New South Wales, Australia
Townsville University Hospital
Douglas, Queensland, Australia
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
Beijing Cancer Hospital
Beijing, Beijing Municipality, China
Xinqiao Hospital Affiliated to the Army Medical University
Chongqing, Chongqing Municipality, China
Daping Hospital, Third Military Medical University
Chongqing, Chongqing Municipality, China
Fujian Cancer Hospital
Fuzhou, Fujian, China
The First Hospital of Lanzhou University
Lanzhou, Gansu, China
Cancer Center of Guangzhou Medical University
Guangzhou, Guangdong, China
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
Jingzhou Central Hospital
Jingzhou, Hubei, China
The First Peoples Hospital of Chenzhou
Chenzhou, Hunan, China
Changzhou Cancer Hospital
Changzhou, Jiangsu, China
Ansteel Group General Hospital
Anshan, Liaoning, China
Shandong Cancer Hospital
Jinan, Shandong, China
Liaocheng Peoples Hospital
Liaocheng, Shandong, China
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China
Huashan Hospital Affiliated to Fudan University
Shanghai, Shanghai Municipality, China
Shanghai Pulmonary Hospital
Shanghai, Shanghai Municipality, China
West China Hospital, Sichuan University
Chengdu, Sichuan, China
The First Peoples Hospital of Kashgar
Kashgar, Xinjiang, China
Zhejiang Provincial Peoples Hospital
Hangzhou, Zhejiang, China
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China
Huzhou Central Hospital
Huzhou, Zhejiang, China
The First Hospital of Jiaxing
Jiaxing, Zhejiang, China
Jinhua Municipal Central Hospital
Jinhua, Zhejiang, China
Centre Hospitalier Regional Universitaire de Caen
Caen, , France
Institut Curie
Paris, , France
Hopital Europeen Georges Pompidou
Paris, , France
Hopital Charles Nicolle Clinique Pneumologique
Rouen, , France
St Lukes Hospital
Thessaloniki, , Greece
Dong A University Hospital
Seogu, Busan Gwang'yeogsi, South Korea
Cha Bundang Medical Center, Cha University
BundangGu SeongnamSi, Gyeonggi-do, South Korea
Samsung Medical Center
GangnamGu, Seoul Teugbyeolsi, South Korea
Korea University Guro Hospital
GuroGu, Seoul Teugbyeolsi, South Korea
Kangbuk Samsung Hospital
JongnoGu, Seoul Teugbyeolsi, South Korea
Severance Hospital Yonsei University Health System
SeodaemunGu, Seoul Teugbyeolsi, South Korea
Seoul National University Hospital
Seoul, Seoul Teugbyeolsi, South Korea
Gangnam Severance Hospital, Yonsei University Health System
Seoul, Seoul Teugbyeolsi, South Korea
Ulsan University Hospital
Donggu, Ulsan Gwang'yeogsi, South Korea
Ajou University Hospital
Suwon, , South Korea
Centro Oncologico de Galicia
A Coruña, , Spain
Ch Provincial de Castellon
Castellon, , Spain
Complejo Asistencial Universitario de Leon
León, , Spain
Hospital Universitario Central de Asturias
Oviedo, , Spain
Fundacion Instituto Valenciano de Oncologia Ivo
Valencia, , Spain
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2021-001075-17
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CTR20212782
Identifier Type: OTHER
Identifier Source: secondary_id
AdvanTIG-205
Identifier Type: -
Identifier Source: org_study_id
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