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

AdvanTIG-205: A Phase 2, Randomized Study of Ociperlimab (BGB-A1217) and Tislelizumab With Chemotherapy in Patients With Previously Untreated Locally Advanced, Unresectable, or Metastatic Non-Small Cell Lung Cancer (NSCLC)

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.

Study Overview

• Status: Completed
• Conditions: Nonsmall Cell Lung Cancer, Stage IV; Locally Advanced, Unresectable, or Metastatic Nonsmall Cell Lung Cancer (NSCLC); Nonsmall Cell Lung Cancer, Stage IIIB
• Intervention / Treatment: Drug: Tislelizumab; Drug: Ociperlimab; Drug: Carboplatin; Drug: Paclitaxel; Drug: Nab paclitaxel; Drug: Cisplatin; Drug: Pemetrexed; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 272
• Phase: Phase 2

Contacts and Locations

Study Locations

• Australia
  • New South Wales
    • East Albury, New South Wales, Australia, 2640
      • Border Medical Oncology
    • Frenchs Forest, New South Wales, Australia, 2086
      • Northern Beaches Hospital
    • Port Macquarie, New South Wales, Australia, 2444
      • Port Macquarie Base Hospital
  • Queensland
    • Douglas, Queensland, Australia, 4814
      • Townsville University Hospital
    • Toowoomba, Queensland, Australia, 4350
      • Toowoomba Hospital
  • Tasmania
    • Launceston, Tasmania, Australia, 7250
      • Launceston General Hospital
  • Victoria
    • Frankston, Victoria, Australia, 3199
      • Peninsula and South Eastern Haematology and Oncology Group
    • Heidelberg, Victoria, Australia, 3084
      • Olivia Newton John Cancer Wellness and Research Centre
• Austria
  • Vienna, Austria, 1140
    • Klinik Penzing Wien, Abteilung Fur Atemwegs
• China
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 100142
      • Beijing Cancer Hospital
  • Chongqing Municipality
    • Chongqing, Chongqing Municipality, China, 400037
      • Xinqiao Hospital Affiliated to the Army Medical University
    • Chongqing, Chongqing Municipality, China, 400042
      • Daping Hospital, Third Military Medical University
  • Fujian
    • Fuzhou, Fujian, China, 350014
      • Fujian Cancer Hospital
  • Gansu
    • Lanzhou, Gansu, China, 730000
      • The First Hospital of Lanzhou University
  • Guangdong
    • Guangzhou, Guangdong, China, 510030
      • Cancer Center of Guangzhou Medical University
  • Heilongjiang
    • Harbin, Heilongjiang, China, 150000
      • Harbin medical university cancer hospital
  • Henan
    • Zhengzhou, Henan, China, 450052
      • The first affiliated hospital of Zhengzhou university
  • Hubei
    • Jingzhou, Hubei, China, 434020
      • Jingzhou Central Hospital
  • Hunan
    • Chenzhou, Hunan, China, 423000
      • The First Peoples Hospital of Chenzhou
  • Jiangsu
    • Changzhou, Jiangsu, China, 213001
      • Changzhou Cancer hospital
  • Liaoning
    • Anshan, Liaoning, China, 114000
      • Ansteel Group General Hospital
  • Shandong
    • Jinan, Shandong, China, 250117
      • Shandong Cancer Hospital
    • Liaocheng, Shandong, China, 252000
      • Liaocheng Peoples Hospital
  • Shanghai Municipality
    • Shanghai, Shanghai Municipality, China, 200433
      • Shanghai Pulmonary Hospital
    • Shanghai, Shanghai Municipality, China, 200000
      • Fudan University Shanghai Cancer Center
    • Shanghai, Shanghai Municipality, China, 200040
      • Huashan Hospital affiliated to Fudan University
  • Sichuan
    • Chengdu, Sichuan, China, 610041
      • West China Hospital, Sichuan University
  • Xinjiang
    • Kashgar, Xinjiang, China, 844099
      • The First Peoples Hospital of Kashgar
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310022
      • Zhejiang Cancer Hospital
    • Hangzhou, Zhejiang, China, 310014
      • Zhejiang Provincial Peoples Hospital
    • Huzhou, Zhejiang, China, 313003
      • Huzhou Central Hospital
    • Jiaxing, Zhejiang, China, 314001
      • The First Hospital of Jiaxing
    • Jinhua, Zhejiang, China, 321000
      • Jinhua municipal central hospital
• France
  • Caen, France, 14000
    • Centre Hospitalier Regional Universitaire de Caen
  • Paris, France, 75015
    • Hôpital Européen Georges Pompidou
  • Paris, France, 75005
    • Institut Curie
  • Rouen, France, 76000
    • Hopital Charles Nicolle Clinique Pneumologique
• Greece
  • Thessaloniki, Greece, 55236
    • St Lukes Hospital
• South Korea
  • Suwon, South Korea, 16499
    • Ajou University Hospital
  • Busan Gwang'yeogsi
    • Seogu, Busan Gwang'yeogsi, South Korea, 49201
      • Dong A University Hospital
  • Gyeonggi-do
    • BundangGu SeongnamSi, Gyeonggi-do, South Korea, 13496
      • CHA Bundang Medical Center, CHA University
  • Seoul Teugbyeolsi
    • GangnamGu, Seoul Teugbyeolsi, South Korea, 06351
      • Samsung Medical Center
    • GuroGu, Seoul Teugbyeolsi, South Korea, 08308
      • Korea University Guro Hospital
    • JongnoGu, Seoul Teugbyeolsi, South Korea, 03181
      • Kangbuk Samsung Hospital
    • SeodaemunGu, Seoul Teugbyeolsi, South Korea, 03722
      • Severance Hospital Yonsei University Health System
    • Seoul, Seoul Teugbyeolsi, South Korea, 03080
      • Seoul National University Hospital
    • Seoul, Seoul Teugbyeolsi, South Korea, 06273
      • Gangnam Severance Hospital, Yonsei University Health System
  • Ulsan Gwang'yeogsi
    • Donggu, Ulsan Gwang'yeogsi, South Korea, 44033
      • Ulsan University Hospital
• Spain
  • A Coruña, Spain, 15009
    • Centro Oncologico de Galicia
  • Castellon, Spain, 50009
    • Ch Provincial de Castellon
  • León, Spain, 24071
    • Complejo Asistencial Universitario de León
  • Oviedo, Spain, 33011
    • Hospital Universitario Central de Asturias
  • Valencia, Spain, 46009
    • Fundacion Instituto Valenciano de Oncologia Ivo
• United States
  • California
    • Los Angeles, California, United States, 90067-2011
      • Valkyrie Clinical Trials
  • Iowa
    • Iowa City, Iowa, United States, 52242-1009
      • University of Iowa Hospitals and Clinics
  • Nevada
    • Las Vegas, Nevada, United States, 89169-3321
      • Comprehensive Cancer Center of Nevada
  • New York
    • New Hyde Park, New York, United States, 11042-1118
      • Rj Zuckerberg Cancer Center
    • New York, New York, United States, 10028-0517
      • North Shore Hematology Oncology Associates Dba New York Cancer and Blood Specialists (New York)
    • Port Jefferson Station, New York, United States, 11776-8066
      • North Shore Hematology Oncology Associates Dba New York Cancer and Blood Specialists
    • The Bronx, New York, United States, 10469-5930
      • Ny Cancer and Blood Specialists
  • Ohio
    • Dayton, Ohio, United States, 45409-1328
      • Xcancerdayton Physician Network
  • Tennessee
    • Knoxville, Tennessee, United States, 37909-1327
      • Tennessee Cancer Specialist
  • Texas
    • Austin, Texas, United States, 78705-1163
      • Texas Oncology Tyler Longview
  • Washington
    • Spokane Valley, Washington, United States, 99216-1020
      • Cancer Care Northwest

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Key Inclusion Criteria:

1. 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.
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.

Key Exclusion Criteria:

1. 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.
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.

Note: Additional protocol-defined inclusion and exclusion criteria may have applied.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: Tislelizumab; 200 mg IV Q3W; Other Names: BGB-A317; Drug: Ociperlimab; 900 mg intravenously (IV) once every 3 weeks (Q3W); Other Names: BGB-A1217; Drug: Carboplatin; Area under the concentration-time curve (AUC) of 5 or 6, administered on Day 1 of each 21-day cycle; Drug: Paclitaxel; 75 or 200 mg per square meter (mg/m²) of body surface area, administered on Day 1 of each 21-day cycle; Drug: Nab paclitaxel; 100 mg/m², administered intravenously on Days 1, 8, and 15 of each 21-day cycle; Drug: Cisplatin; 75 mg/m², administered intravenously on Day 1 of each 21-day cycle; Drug: Pemetrexed; 500 mg/m² administered intravenously on Day 1 of each 21-day cycle
Placebo Comparator: 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.	Drug: Tislelizumab; 200 mg IV Q3W; Other Names: BGB-A317; Drug: Carboplatin; Area under the concentration-time curve (AUC) of 5 or 6, administered on Day 1 of each 21-day cycle; Drug: Paclitaxel; 75 or 200 mg per square meter (mg/m²) of body surface area, administered on Day 1 of each 21-day cycle; Drug: Nab paclitaxel; 100 mg/m², administered intravenously on Days 1, 8, and 15 of each 21-day cycle; Drug: Cisplatin; 75 mg/m², administered intravenously on Day 1 of each 21-day cycle; Drug: Pemetrexed; 500 mg/m² administered intravenously on Day 1 of each 21-day cycle; Drug: Placebo; Administered intravenously Q3W to match ociperlimab

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Objective Response Rate (ORR)	Objective response rate is defined as the percentage of participants who had a confirmed complete response (CR) or partial response (PR) as assessed by the investigator per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 Tumor assessments. CR is defined as the disappearance of all target and non-target lesions and no new lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm. PR is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.	From randomization up to the final efficacy analysis data cut-off date of 04 September 2024; Up to 33 months
Duration of Response (DOR)	DOR was defined as the time from the first documented objective response to documented radiological disease progression as assessed by the investigator using RECIST v1.1, or death from any cause, whichever occurred first. Median DOR was estimated using the Kaplan-Meier method. Progressive disease is captured as at least a 20% increase in the sum of diameters of target lesions, using the smallest sum on study as the reference (including the baseline sum if it was the smallest). In addition to the 20% relative increase, the sum also had to show an absolute increase of at least 5 mm.	From randomization up to the final efficacy analysis data cut-off date of 04 September 2024; Up to 33 months
Overall Survival (OS)	OS was defined as the time from randomization to the documented date of death for participants who died on or before the clinical cutoff date. Median OS was calculated using the Kaplan-Meier method. Data for participants who were alive at the clinical cutoff date were censored at their last known alive date, defined as either the clinical cutoff date for those still on treatment or the most recent available date confirming they were alive, whichever occurred first.	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)	The number of participants who experienced TEAEs and SAEs was reported. An adverse event refers to any unintended or unfavorable sign, symptom, or condition (including abnormal lab results) that occurs during the study, regardless of whether it is linked to the study drug. Investigators evaluated the severity of each adverse event according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) v5.	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)

Collaborators and Investigators

• Sponsor: BeiGene

Study record dates

Study Major Dates

• Study Start (Actual): November 16, 2021
• Primary Completion (Actual): September 4, 2024
• Study Completion (Actual): September 4, 2024

Study Registration Dates

• First Submitted: August 16, 2021
• First Submitted That Met QC Criteria: August 16, 2021
• First Posted (Actual): August 20, 2021

Study Record Updates

• Last Update Posted (Estimated): September 16, 2025
• Last Update Submitted That Met QC Criteria: August 28, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: Lung Cancer; Anti-PD-1; metastatic; Tislelizumab; Non-Squamous; BGB-A317; Ociperlimab; BGB-A1217; Anti-TIGIT
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Lung Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplastic Processes; Carcinoma, Bronchogenic; Bronchial Neoplasms; Pathological Conditions, Signs and Symptoms; Lung Neoplasms; Neoplasm Metastasis; Carcinoma, Non-Small-Cell Lung; Amino Acids, Peptides, and Proteins; Proteins; Organic Chemicals; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Substandard Drugs; Pharmaceutical Preparations; Hydrocarbons; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Terpenes; Inorganic Chemicals; Chlorine Compounds; Nitrogen Compounds; Coordination Complexes; Guanine; Hypoxanthines; Purinones; Purines; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Dicarboxylic; Taxoids; Cyclodecanes; Diterpenes; Platinum Compounds; Albumins; Albumin-Bound Paclitaxel; Pemetrexed; Carboplatin; Paclitaxel; Cisplatin; Counterfeit Drugs; tislelizumab
• Other Study ID Numbers: AdvanTIG-205; 2021-001075-17 (EudraCT Number); CTR20212782 (Other Identifier: ChinaDrugTrials)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: BeiGene shares data on completed studies responsibly and provides qualified scientific and medical researchers access to data and supporting documentation for clinical trials in dossiers for medicines and indications after submission and approval in the United States, China, and Europe. Clinical trials supporting subsequent local approvals, new indications, or combination products are eligible for sharing once corresponding regulatory approvals are achieved. BeiGene shares data only when permitted by applicable data privacy and security laws and regulations, when it is feasible to do so without compromising the privacy of study participants, and other considerations. Qualified researchers with appropriate competencies who are engaged in novel scientific research may submit a request for participant-level data with a research proposal for BeiGene review. Research teams must include a biostatistician and sign a Data Sharing Agreement prior to receiving access to clinical trial data.
• IPD Sharing Time Frame: See plan description
• IPD Sharing Access Criteria: See plan description
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No