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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05014815
Recruitment Status : Recruiting
First Posted : August 20, 2021
Last Update Posted : January 4, 2023
Sponsor:
Information provided by (Responsible Party):
BeiGene

Study Description
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Brief Summary:
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

Condition or disease Intervention/treatment Phase
Locally Advanced, Unresectable, or Metastatic Nonsmall Cell Lung Cancer (NSCLC) Nonsmall Cell Lung Cancer, Stage IV Drug: Ociperlimab Drug: Tislelizumab Drug: histology-based chemotherapy Drug: Placebo Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 270 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
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)
Actual Study Start Date : November 16, 2021
Estimated Primary Completion Date : March 2024
Estimated Study Completion Date : November 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Arms and Interventions
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Arm Intervention/treatment
Experimental: Arm A: Ociperlimab + tislelizumab histology-based chemotherapy Drug: Ociperlimab
Ociperlimab intravenous injection
Other Name: BGB-A1217

Drug: Tislelizumab
Tislelizumab intravenous injection
Other Name: BGB-A317

Drug: histology-based chemotherapy
Administered intravenously
Placebo Comparator: Arm B: Placebo + tislelizumab + histology-based chemotherapy Drug: Tislelizumab
Tislelizumab intravenous injection
Other Name: BGB-A317

Drug: histology-based chemotherapy
Administered intravenously

Drug: Placebo
Administered as an intravenous injection


Outcome Measures
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Primary Outcome Measures :
  1. Progression-free Survival (PFS) as Assessed by Investigators [ Time Frame: Up to approximately 30 months ]
    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


Secondary Outcome Measures :
  1. Overall Response Rate (ORR) as Assessed by Investigators [ Time Frame: Up to approximately 30 months ]
    ORR will be defined as the proportion of participants with a documented, confirmed complete response or partial response per RECIST v1.1.

  2. Duration of Response (DoR) As Assessed by Investigators [ Time Frame: Up to approximately 30 months ]
    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

  3. Overall Survival (OS) [ Time Frame: Up to approximately 30 months ]
    OS will be defined as the time from the date of randomization to the date of death due to any cause.

  4. Number of Participants Experiencing Adverse Events (AEs) [ Time Frame: 90 days (±14) after last dose ]
    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).

  5. Serum concentrations of ociperlimab and tislelizumab at prespecified timepoints [ Time Frame: Up to approximately 12 months or end of treatment visit ]
  6. Immunogenic responses to ociperlimab and tislelizumab, evaluated through detection of anti-drug antibodies (ADAs). [ Time Frame: Up to approximately 12 months or end of treatment visit ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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. 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.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05014815


Contacts
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Contact: BeiGene, USA, Inc 1-877-828-5568 ClinicalTrials@beigene.com

Locations
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Sponsors and Collaborators
BeiGene
More Information
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Responsible Party: BeiGene
ClinicalTrials.gov Identifier: NCT05014815    
Other Study ID Numbers: AdvanTIG-205
2021-001075-17 ( EudraCT Number )
First Posted: August 20, 2021    Key Record Dates
Last Update Posted: January 4, 2023
Last Verified: January 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by BeiGene:
metastatic
Lung Cancer
Non-Squamous
Ociperlimab
Tislelizumab
 Anti-PD-1
BGB-A317
BGB-A1217
Anti-TIGIT
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
 Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Tislelizumab
Antineoplastic Agents, Immunological
Antineoplastic Agents