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

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ClinicalTrials.gov Identifier: NCT05014815
Recruitment Status : Recruiting
First Posted : August 20, 2021
Last Update Posted : May 5, 2022
Sponsor:
Information provided by (Responsible Party):
BeiGene

Study Description
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Brief Summary:
This randomized double-blind study 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 stage IV non-squamous or squamous NSCLC

Condition or disease Intervention/treatment Phase
Non Small Cell Lung Cancer 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 : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 2, Randomized, Double-blind Study of Ociperlimab (BGB A1217) and Tislelizumab With Chemotherapy in Patients With Metastatic Non-Small Cell Lung Cancer (NSCLC) Without Sensitizing EGFR or ALK Mutations Who Have Received No Previous Treatment for Metastatic Disease
Actual Study Start Date : November 16, 2021
Estimated Primary Completion Date : April 2023
Estimated Study Completion Date : April 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. 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.

  3. 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).

  4. Serum concentrations of ociperlimab and tislelizumab at prespecified timepoints [ Time Frame: Up to approximately 12 months or end of treatment visit ]
  5. 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 confirmed metastatic (Stage IV) squamous or non-squamous NSCLC.
  2. Treatment-naive for metastatic squamous or non-squamous NSCLC.
  3. Agreement to provide archival tissue or fresh biopsy for the prospectively determination of PD-L1 levels and retrospective analysis of other biomarkers.

  4. At least 1 measurable lesion as defined per RECIST v1.1.

    .

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

Key Exclusion Criteria:

  1. Diagnosed with NSCLC that harbors an EGFR-sensitizing mutation or ALK gene translocation.
  2. Prior therapy with an anti-programmed cell death protein (PD-1), anti-PD-L1, anti-programmed cell death ligand-2 (PD-L2), anti-TIGIT, or any other antibody or drug specifically targeting T-cell costimulation or checkpoint pathways.
  3. Active leptomeningeal disease or uncontrolled, untreated brain metastasis.
  4. Any active malignancy ≤ 2 years before randomization except for the specific cancer under investigation in this study and any locally recurring cancer that has been treated curatively (for example, resected basal or squamous cell skin cancer, superficial bladder cancer, carcinoma in situ of the cervix or breast).

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 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: May 5, 2022
Last Verified: May 2022
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