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

NCT05014815 | Completed Phase 2 Results DMC FDA Drug

• 3 other identifiers: AdvanTIG-2052021-001075-17CTR20212782
• Study Type: interventional
• Target: 272
• Locations: 7 countries
• Sites: 56

Brief Summary

This study aimed to evaluate the safety and effectiveness of ociperlimab combined with tislelizumab and chemotherapy, compared to tislelizumab and chemotherapy alone, in participants with non-small cell lung cancer (NSCLC) that was locally advanced, could not be removed by surgery, or had spread to other parts of the body.

Conditions

Locally Advanced, Unresectable, or Metastatic Nonsmall Cell Lung Cancer (NSCLC); Nonsmall Cell Lung Cancer, Stage IIIB; Nonsmall Cell Lung Cancer, Stage IV

Keywords

metastatic; Lung Cancer; Non-Squamous; Ociperlimab; Tislelizumab; Anti-PD-1; BGB-A317; BGB-A1217; Anti-TIGIT

Outcome Measures

Primary Outcomes (1)

• Progression-free Survival (PFS)

  PFS was defined as the time from randomization to the first objectively documented disease progression as assessed by the investigator per Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST v1.1) or death from any cause, whichever occurred first. Median PFS was estimated using the Kaplan-Meier method.

  From randomization up to the final efficacy analysis data cut-off date of 04 September 2024; Up to 33 months

Secondary Outcomes (4)

• Objective Response Rate (ORR)

  From randomization up to the final efficacy analysis data cut-off date of 04 September 2024; Up to 33 months

• Duration of Response (DOR)

  From randomization up to the final efficacy analysis data cut-off date of 04 September 2024; Up to 33 months

• Overall Survival (OS)

  From randomization up to the final efficacy analysis data cut-off date of 04 September 2024; Up to 33 months

• Number of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)

  From first dose of study drug to 30 days after last dose, up to the study completion date cut-off date of 04 September 2024 (up to 32.4 months)

Study Arms (2)

Arm A (O+T+C)

EXPERIMENTAL

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.

Drug: Ociperlimab; Drug: Tislelizumab; Drug: Carboplatin; Drug: Paclitaxel; Drug: Nab paclitaxel; Drug: Cisplatin; Drug: Pemetrexed

Arm B (P+T+C)

PLACEBO COMPARATOR

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.

Drug: Tislelizumab; Drug: Carboplatin; Drug: Paclitaxel; Drug: Nab paclitaxel; Drug: Cisplatin; Drug: Pemetrexed; Drug: Placebo

Interventions

Ociperlimab DRUG

900 mg intravenously (IV) once every 3 weeks (Q3W)

Also known as: BGB-A1217

Arm A (O+T+C)

Tislelizumab DRUG

200 mg IV Q3W

Also known as: BGB-A317

Arm A (O+T+C); Arm B (P+T+C)

Carboplatin DRUG

Area under the concentration-time curve (AUC) of 5 or 6, administered on Day 1 of each 21-day cycle

Arm A (O+T+C); Arm B (P+T+C)

Paclitaxel DRUG

75 or 200 mg per square meter (mg/m²) of body surface area, administered on Day 1 of each 21-day cycle

Arm A (O+T+C); Arm B (P+T+C)

Nab paclitaxel DRUG

100 mg/m², administered intravenously on Days 1, 8, and 15 of each 21-day cycle

Arm A (O+T+C); Arm B (P+T+C)

Cisplatin DRUG

75 mg/m², administered intravenously on Day 1 of each 21-day cycle

Arm A (O+T+C); Arm B (P+T+C)

Pemetrexed DRUG

500 mg/m² administered intravenously on Day 1 of each 21-day cycle

Arm A (O+T+C); Arm B (P+T+C)

Placebo DRUG

Administered intravenously Q3W to match ociperlimab

Arm B (P+T+C)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants had histologically or cytologically confirmed locally advanced or recurrent non-small cell lung cancer (NSCLC) that was not eligible for curative surgical resection and/or definitive radiotherapy, with or without chemotherapy. Alternatively, participants had metastatic non-squamous or squamous NSCLC.
• 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.
• 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.
• 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.
• Participants had an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.

You may not qualify if:

• Participants were excluded if they had known mutations in any of the following genes:
• 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.
• Participants who had received prior treatment with EGFR inhibitors, ALK inhibitors, or other targeted therapies for known driver mutations.
• 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.
• 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.
• 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.

Sponsors & Collaborators

• BeiGene: lead

Study Sites (64)

Valkyrie Clinical Trials

Los Angeles, California, 90067-2011, United States

Location

University of Iowa Hospitals and Clinics

Iowa City, Iowa, 52242-1009, United States

Location

Comprehensive Cancer Center of Nevada

Las Vegas, Nevada, 89169-3321, United States

Location

Rj Zuckerberg Cancer Center

New Hyde Park, New York, 11042-1118, United States

Location

North Shore Hematology Oncology Associates Dba New York Cancer and Blood Specialists (New York)

New York, New York, 10028-0517, United States

Location

North Shore Hematology Oncology Associates Dba New York Cancer and Blood Specialists

Port Jefferson Station, New York, 11776-8066, United States

Location

Ny Cancer and Blood Specialists

The Bronx, New York, 10469-5930, United States

Location

Xcancerdayton Physician Network

Dayton, Ohio, 45409-1328, United States

Location

Tennessee Cancer Specialist

Knoxville, Tennessee, 37909-1327, United States

Location

Texas Oncology Tyler Longview

Austin, Texas, 78705-1163, United States

Location

Cancer Care Northwest

Spokane Valley, Washington, 99216-1020, United States

Location

Border Medical Oncology

East Albury, New South Wales, 2640, Australia

Location

Northern Beaches Hospital

Frenchs Forest, New South Wales, 2086, Australia

Location

Port Macquarie Base Hospital

Port Macquarie, New South Wales, 2444, Australia

Location

Townsville University Hospital

Douglas, Queensland, 4814, Australia

Location

Toowoomba Hospital

Toowoomba, Queensland, 4350, Australia

Location

Launceston General Hospital

Launceston, Tasmania, 7250, Australia

Location

Peninsula and South Eastern Haematology and Oncology Group

Frankston, Victoria, 3199, Australia

Location

Olivia Newton John Cancer Wellness and Research Centre

Heidelberg, Victoria, 3084, Australia

Location

Klinik Penzing Wien, Abteilung Fur Atemwegs

Vienna, 1140, Austria

Location

Beijing Cancer Hospital

Beijing, Beijing Municipality, 100142, China

Location

Xinqiao Hospital Affiliated to the Army Medical University

Chongqing, Chongqing Municipality, 400037, China

Location

Daping Hospital, Third Military Medical University

Chongqing, Chongqing Municipality, 400042, China

Location

Fujian Cancer Hospital

Fuzhou, Fujian, 350014, China

Location

The First Hospital of Lanzhou University

Lanzhou, Gansu, 730000, China

Location

Cancer Center of Guangzhou Medical University

Guangzhou, Guangdong, 510030, China

Location

Harbin Medical University Cancer Hospital

Harbin, Heilongjiang, 150000, China

Location

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, 450052, China

Location

Jingzhou Central Hospital

Jingzhou, Hubei, 434020, China

Location

The First Peoples Hospital of Chenzhou

Chenzhou, Hunan, 423000, China

Location

Changzhou Cancer Hospital

Changzhou, Jiangsu, 213001, China

Location

Ansteel Group General Hospital

Anshan, Liaoning, 114000, China

Location

Shandong Cancer Hospital

Jinan, Shandong, 250117, China

Location

Liaocheng Peoples Hospital

Liaocheng, Shandong, 252000, China

Location

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200000, China

Location

Huashan Hospital Affiliated to Fudan University

Shanghai, Shanghai Municipality, 200040, China

Location

Shanghai Pulmonary Hospital

Shanghai, Shanghai Municipality, 200433, China

Location

West China Hospital, Sichuan University

Chengdu, Sichuan, 610041, China

Location

The First Peoples Hospital of Kashgar

Kashgar, Xinjiang, 844099, China

Location

Zhejiang Provincial Peoples Hospital

Hangzhou, Zhejiang, 310014, China

Location

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, 310022, China

Location

Huzhou Central Hospital

Huzhou, Zhejiang, 313003, China

Location

The First Hospital of Jiaxing

Jiaxing, Zhejiang, 314001, China

Location

Jinhua Municipal Central Hospital

Jinhua, Zhejiang, 321000, China

Location

Centre Hospitalier Regional Universitaire de Caen

Caen, 14000, France

Location

Institut Curie

Paris, 75005, France

Location

Hopital Europeen Georges Pompidou

Paris, 75015, France

Location

Hopital Charles Nicolle Clinique Pneumologique

Rouen, 76000, France

Location

St Lukes Hospital

Thessaloniki, 55236, Greece

Location

Dong A University Hospital

Seogu, Busan Gwang'yeogsi, 49201, South Korea

Location

Cha Bundang Medical Center, Cha University

BundangGu SeongnamSi, Gyeonggi-do, 13496, South Korea

Location

Samsung Medical Center

GangnamGu, Seoul Teugbyeolsi, 06351, South Korea

Location

Korea University Guro Hospital

GuroGu, Seoul Teugbyeolsi, 08308, South Korea

Location

Kangbuk Samsung Hospital

JongnoGu, Seoul Teugbyeolsi, 03181, South Korea

Location

Severance Hospital Yonsei University Health System

SeodaemunGu, Seoul Teugbyeolsi, 03722, South Korea

Location

Seoul National University Hospital

Seoul, Seoul Teugbyeolsi, 03080, South Korea

Location

Gangnam Severance Hospital, Yonsei University Health System

Seoul, Seoul Teugbyeolsi, 06273, South Korea

Location

Ulsan University Hospital

Donggu, Ulsan Gwang'yeogsi, 44033, South Korea

Location

Ajou University Hospital

Suwon, 16499, South Korea

Location

Centro Oncologico de Galicia

A Coruña, 15009, Spain

Location

Ch Provincial de Castellon

Castellon, 50009, Spain

Location

Complejo Asistencial Universitario de Leon

León, 24071, Spain

Location

Hospital Universitario Central de Asturias

Oviedo, 33011, Spain

Location

Fundacion Instituto Valenciano de Oncologia Ivo

Valencia, 46009, Spain

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Neoplasm Metastasis; Lung Neoplasms

Interventions

tislelizumab; Carboplatin; Paclitaxel; Taxes; Cisplatin; Pemetrexed

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Diterpenes; Terpenes; Economics; Health Care Economics and Organizations; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Dicarboxylic

Results Point of Contact

• Title: Study Director
• Organization: BeiGene

clinicaltrials@beigene.com

1 877-828-5568

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 16, 2021
• First Posted: August 20, 2021
• Study Start: November 16, 2021
• Primary Completion: September 4, 2024
• Study Completion: September 4, 2024
• Last Updated: September 16, 2025
• Results First Posted: September 16, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: See plan description
• Access Criteria: See plan description

Locations

KR (10); ES (5); AU (1); CN (24); FR (4); GR (1); US (11)