Ociperlimab With Tislelizumab and Chemotherapy in Patients 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 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

Study Overview

• Status: Active, not recruiting
• Conditions: Nonsmall Cell Lung Cancer, Stage IV; Locally Advanced, Unresectable, or Metastatic Nonsmall Cell Lung Cancer (NSCLC)
• Intervention / Treatment: Drug: Ociperlimab; Drug: Tislelizumab; Drug: histology-based chemotherapy; Drug: Placebo

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

Contacts and Locations

• Study Contact: Name: BeiGene, USA, Inc; Phone Number: 1-877-828-5568; Email: ClinicalTrials@beigene.com

Study Locations

• Australia
  • New South Wales
    • 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
  • Victoria
    • Frankston, Victoria, Australia, 3199
      • Peninsula & South Eastern Hematology and Oncology group
    • Heidelberg, Victoria, Australia, 3084
      • Olivia Newton-John Cancer Wellness & Research Centre
• Austria
  • Krems An Der Donau
    • Krems, Krems An Der Donau, Austria, 3500
      • Universitätsklinikum Krems
• China
  • Beijing
    • Beijing, Beijing, China, 100142
      • Beijing Cancer Hospital
    • Beijing, Beijing, China, 100029
      • China-Japan Friendship Hospital
  • Chongqing
    • Chongqing, Chongqing, China, 40037
      • Xin Qiao Hospital Affiliated to The Army Medical University
    • Chongqing, Chongqing, China, 40042
      • Army Medical Center of PLA
  • Fujian
    • Fujian, Fujian, China
      • Fujian cancer hospital
  • Gansu
    • Lanzhou, Gansu, China, 730000
      • First Hospital of Lanzhou University
  • Guangdong
    • Guangzhou, Guangdong, China, 510059
      • Cancer Center of Guangzhou Medical University
  • Heilongjiang
    • Harbin, Heilongjiang, China, 100142
      • Affiliated Tumor Hospital of Harbin Medical University
  • Henan
    • Zhengzhou, Henan, China, 450052
      • First Affiliated Hospital of Zhengzhou University
  • Hubei
    • Jingzhou, Hubei, China, 434020
      • Jingzhou Central Hospital
    • Wuhan, Hubei, China, 430073
      • Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology
  • Hunan
    • Chenzhou, Hunan, China, 423099
      • Chenzhou First People's Hospital
  • Jiangsu
    • Changzhou, Jiangsu, China, 213000
      • 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 People's Hospital
  • Shanghai
    • Shanghai, Shanghai, China, 200032
      • Fudan University Shanghai Cancer Center
    • Shanghai, Shanghai, China, 200040
      • Huashan Hospital affiliated to Fudan University
    • Shanghai, Shanghai, China, 200433
      • Shanghai Pulmonary Hospital
  • Sichuan
    • Chengdu, Sichuan, China, 610041
      • West China Hospital ,Sichuan University
  • Xinjiang
    • Kashgar, Xinjiang, China, 844099
      • The First People's Hospital of Kashgar
    • Shihezi, Xinjiang, China, 832099
      • First Affiliated Hospital, School of Medicine, Shihezi University
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310022
      • Zhejiang Cancer Hospital
    • Hangzhou, Zhejiang, China, 310014
      • Zhejiang Provincial People's Hospital
    • Huzhou, Zhejiang, China, 3100
      • Huzhou Central Hospital
    • Jiaxing, Zhejiang, China, 314001
      • The First Hospital of Jiaxing
    • Jinhua, Zhejiang, China, 321000
      • Jinhua municipal central hospital
• France
  • Paris, France, 75005
    • Institut Curie
  • Cedex
    • Paris, Cedex, France, 75098
      • Hopital Europeen Georges Pompidou
    • Rouen, Cedex, France, 76031
      • Hopital Charles Nicolle - Centre Hospitalier Universitaire de Rouen
• Korea, Republic of
  • Busan, Korea, Republic of, 49201
    • Dong-A University Hospital
  • Gyeonggi-do, Korea, Republic of, 16499
    • Ajou University Hospital
  • Gyeonggi-do, Korea, Republic of, 13496
    • CHA Bundang Medical Center, CHA University
  • Seoul, Korea, Republic of, 03080
    • Seoul National University Hospital
  • Seoul, Korea, Republic of, 03722
    • Severance Hospital, Yonsei University Health System
  • Seoul, Korea, Republic of, 08308
    • Korea University Guro Hospital
  • Seoul, Korea, Republic of, 06351
    • Samsung Medical Center
  • Seoul, Korea, Republic of, 03181
    • Kangbuk Samsung Hospital
  • Ulsan, Korea, Republic of, 44033
    • Ulsan University Hospital
  • Gangnam-Gu
    • Seoul, Gangnam-Gu, Korea, Republic of, 06273
      • Gangnam Severance Hospital, Yonsei University Health System
• Spain
  • A Coruña, Spain, 15009
    • Centro Oncológico de Galicia
  • Madrid, Spain, 28033
    • MD Anderson Cancer Center - Madrid
  • Austrias
    • Oviedo, Austrias, Spain, 33011
      • Hospital Universitario Central de Asturias
  • Comunidad De Valencia
    • Castillón, Comunidad De Valencia, Spain, 50009
      • Consorcio Hospitalario Provincial de Castellón
    • Valencia, Comunidad De Valencia, Spain, 46009
      • Instituto Valenciano de Oncologia-IVO
  • Leon
    • León, Leon, Spain, 24071
      • Hospital Universitario de León
• United States
  • California
    • Los Angeles, California, United States, 90067
      • Valkyrie Clinical Trials
  • Iowa
    • Iowa City, Iowa, United States, 52242
      • University of Iowa Hospitals and Clinics
  • Nevada
    • Henderson, Nevada, United States, 89074
      • Comprehensive Cancer Center of Nevada
  • New York
    • Lake Success, New York, United States, 11040
      • Northwell Health-Monter Cancer Center
  • Ohio
    • Dayton, Ohio, United States, 45409
      • Xcancer_Dayton Physician Network
  • Tennessee
    • Knoxville, Tennessee, United States, 37909
      • Tennessee Cancer Specialist
  • Texas
    • Tyler, Texas, United States, 75702
      • Texas Oncology (Tyler) - USOR
  • Washington
    • Spokane Valley, Washington, United States, 99216
      • 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. 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.
2. 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.
3. 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.

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

   .

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

Key Exclusion Criteria:

1. 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
2. Prior treatment with EGFR inhibitors, ALK inhibitors, or targeted therapy for other driver mutations.
3. Any prior therapy targeting T-cell costimulation or checkpoint pathways in metastatic NSCLC.
4. Any condition that required systemic treatment with either corticosteroids (> 10 mg daily of prednisone or equivalent) or other immunosuppressive medication ≤ 14 days before randomization.
5. 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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm A: Ociperlimab + tislelizumab histology-based chemotherapy	Drug: Ociperlimab; Ociperlimab intravenous injection; Other Names: BGB-A1217; Drug: Tislelizumab; Tislelizumab intravenous injection; Other Names: BGB-A317; Drug: histology-based chemotherapy; Administered intravenously
Placebo Comparator: Arm B: Placebo + tislelizumab + histology-based chemotherapy	Drug: Tislelizumab; Tislelizumab intravenous injection; Other Names: BGB-A317; Drug: histology-based chemotherapy; Administered intravenously; Drug: Placebo; Administered as an intravenous injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression-free Survival (PFS) as Assessed by Investigators	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	Up to approximately 30 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Response Rate (ORR) as Assessed by Investigators	ORR will be defined as the proportion of participants with a documented, confirmed complete response or partial response per RECIST v1.1.	Up to approximately 30 months
Duration of Response (DoR) As Assessed by Investigators	DOR is defined as the time from the date that response criteria are first met to the date that progressive disease is objectively documented or death, whichever comes first	Up to approximately 30 months
Overall Survival (OS)	OS will be defined as the time from the date of randomization to the date of death due to any cause.	Up to approximately 30 months
Number of Participants Experiencing Adverse Events (AEs)	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).	90 days (±14) after last dose
Serum concentrations of ociperlimab and tislelizumab at prespecified timepoints		Up to approximately 12 months or end of treatment visit
Immunogenic responses to ociperlimab and tislelizumab, evaluated through detection of anti-drug antibodies (ADAs).		Up to approximately 12 months or end of treatment visit

Collaborators and Investigators

• Sponsor: BeiGene

Study record dates

Study Major Dates

• Study Start (Actual): November 16, 2021
• Primary Completion (Estimated): July 1, 2024
• Study Completion (Estimated): November 1, 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 (Actual): September 11, 2023
• Last Update Submitted That Met QC Criteria: September 8, 2023
• Last Verified: September 1, 2023

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: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Antineoplastic Agents; Antineoplastic Agents, Immunological; Tislelizumab
• Other Study ID Numbers: AdvanTIG-205; 2021-001075-17 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No