Clinical trial NCT05014815: Ociperlimab With Tislelizumab and Chemotherapy in Participants With Untreated Metastatic Non-Small Cell Lung Cancer
Official title: 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Locally Advanced, Unresectable, or Metastatic Nonsmall Cell Lung Cancer (NSCLC)
Nonsmall Cell Lung Cancer, Stage IV
Keywords: metastatic
Lung Cancer
Non-Squamous
Ociperlimab
Tislelizumab
Anti-PD-1
BGB-A317
BGB-A1217
Anti-TIGIT
Lead sponsor: BeiGene
Sponsor class: INDUSTRY
First posted: 2021-08-20
Enrollment: 272
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a randomized investigator and participant 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


Eligibility criteria: 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. Participants 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 participantswho 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, articipants 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. Participants 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.

Primary outcomes:
measure: Progression-free Survival (PFS) as Assessed by Investigators
timeFrame: Up to approximately 30 months
Secondary outcomes:
measure: Overall Response Rate (ORR) as Assessed by Investigators
timeFrame: Up to approximately 30 months
measure: Duration of Response (DoR) As Assessed by Investigators
timeFrame: Up to approximately 30 months
measure: Overall Survival (OS)
timeFrame: Up to approximately 30 months
measure: Number of Participants Experiencing Adverse Events (AEs)
timeFrame: 90 days (±14) after last dose
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Valkyrie Clinical Trials
state: California
city: Iowa City
country: United States
facility: University of Iowa Hospitals and Clinics
state: Iowa
city: Henderson
country: United States
facility: Comprehensive Cancer Center of Nevada
state: Nevada
city: Bronx
country: United States
facility: Ny Cancer and Blood Specialists
state: New York
city: Lake Success
country: United States
facility: Rj Zuckerberg Cancer Center
state: New York
city: New York
country: United States
facility: North Shore Hematology Oncology Associates Dba New York Cancer and Blood Specialists (New York)
state: New York
city: Port Jefferson Station
country: United States
facility: North Shore Hematology Oncology Associates Dba New York Cancer and Blood Specialists
state: New York
city: Chapel Hill
country: United States
facility: University of North Carolina At Chapel Hill
state: North Carolina
city: Dayton
country: United States
facility: Xcancerdayton Physician Network
state: Ohio
city: Knoxville
country: United States
facility: Tennessee Cancer Specialist
state: Tennessee
city: Tyler
country: United States
facility: Texas Oncology Tyler Longview
state: Texas
city: Spokane Valley
country: United States
facility: Cancer Care Northwest
state: Washington
city: East Albury
country: Australia
facility: Border Medical Oncology
state: New South Wales
city: Frenchs Forest
country: Australia
facility: Northern Beaches Hospital
state: New South Wales
city: Port Macquarie
country: Australia
facility: Port Macquarie Base Hospital
state: New South Wales
city: Douglas
country: Australia
facility: Townsville University Hospital
state: Queensland
city: Toowoomba
country: Australia
facility: Darling Downs Hospital and Health Service Toowoomba Hospital
state: Queensland
city: Launceston
country: Australia
facility: Launceston General Hospital
state: Tasmania
city: Frankston
country: Australia
facility: Peninsula and South Eastern Haematology and Oncology Group
state: Victoria
city: Heidelberg
country: Australia
facility: Olivia Newton John Cancer Wellness and Research Centre
state: Victoria
city: Vienna
country: Austria
facility: Klinik Penzing Wien, Abteilung Fur Atemwegs
city: Beijing
country: China
facility: Beijing Cancer Hospital
state: Beijing
city: Chongqing
country: China
facility: Xinqiao Hospital Affiliated to the Army Medical University
state: Chongqing
city: Chongqing
country: China
facility: Daping Hospital, Third Military Medical University
state: Chongqing
city: Fuzhou
country: China
facility: Fujian Cancer Hospital
state: Fujian
city: Lanzhou
country: China
facility: The First Hospital of Lanzhou University
state: Gansu
city: Guangzhou
country: China
facility: Cancer Center of Guangzhou Medical University
state: Guangdong
city: Harbin
country: China
facility: Harbin Medical University Cancer Hospital
state: Heilongjiang
city: Zhengzhou
country: China
facility: The First Affiliated Hospital of Zhengzhou University
state: Henan
city: Jingzhou
country: China
facility: Jingzhou Central Hospital
state: Hubei
city: Chenzhou
country: China
facility: The First Peoples Hospital of Chenzhou
state: Hunan
city: Changzhou
country: China
facility: Changzhou Cancer Hospital
state: Jiangsu
city: Anshan
country: China
facility: Ansteel Group General Hospital
state: Liaoning
city: Jinan
country: China
facility: Shandong Cancer Hospital
state: Shandong
city: Liaocheng
country: China
facility: Liaocheng Peoples Hospital
state: Shandong
city: Shanghai
country: China
facility: Fudan University Shanghai Cancer Center
state: Shanghai
city: Shanghai
country: China
facility: Huashan Hospital Affiliated to Fudan University
state: Shanghai
city: Shanghai
country: China
facility: Shanghai Pulmonary Hospital
state: Shanghai
city: Chengdu
country: China
facility: West China Hospital, Sichuan University
state: Sichuan
city: Kashgar
country: China
facility: The First Peoples Hospital of Kashgar
state: Xinjiang
city: Shihezi
country: China
facility: The First Affiliated Hospital of Medical College of Shihezi University
state: Xinjiang
city: Hangzhou
country: China
facility: Zhejiang Provincial Peoples Hospital
state: Zhejiang
city: Hangzhou
country: China
facility: Zhejiang Cancer Hospital
state: Zhejiang
city: Huzhou
country: China
facility: Huzhou Central Hospital
state: Zhejiang
city: Jiaxing
country: China
facility: The First Hospital of Jiaxing
state: Zhejiang
city: Jinhua
country: China
facility: Jinhua Municipal Central Hospital
state: Zhejiang
city: Caen
country: France
facility: Centre Hospitalier Regional Universitaire de Caen
city: Paris
country: France
facility: Institut Curie
city: Paris
country: France
facility: Hopital Europeen Georges Pompidou
city: Rouen
country: France
facility: Hopital Charles Nicolle Clinique Pneumologique
city: Thessaloniki
country: Greece
facility: St Lukes Hospital
city: Busan
country: Korea, Republic of
facility: Dong A University Hospital
state: Busan Gwang'yeogsi
city: Gyeonggido
country: Korea, Republic of
facility: Cha Bundang Medical Center, Cha University
state: Gyeonggi-do
city: Suwonsi
country: Korea, Republic of
facility: Ajou University Hospital
state: Gyeonggi-do
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
state: Seoul Teugbyeolsi
city: Seoul
country: Korea, Republic of
facility: Kangbuk Samsung Hospital
state: Seoul Teugbyeolsi
city: Seoul
country: Korea, Republic of
facility: Severance Hospital Yonsei University Health System
state: Seoul Teugbyeolsi
city: Seoul
country: Korea, Republic of
facility: Gangnam Severance Hospital, Yonsei University Health System
state: Seoul Teugbyeolsi
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
state: Seoul Teugbyeolsi
city: Seoul
country: Korea, Republic of
facility: Korea University Guro Hospital
state: Seoul Teugbyeolsi
city: Donggu
country: Korea, Republic of
facility: Ulsan University Hospital
state: Ulsan Gwang'yeogsi
city: A Coruna
country: Spain
facility: Centro Oncologico de Galicia
city: Castellon
country: Spain
facility: Ch Provincial de Castellon
city: Leon
country: Spain
facility: Complejo Asistencial Universitario de Leon
city: Oviedo
country: Spain
facility: Hospital Universitario Central de Asturias
city: Valencia
country: Spain
facility: Fundacion Instituto Valenciano de Oncologia Ivo
Study officials:
References: