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A Study of Ociperlimab With Tislelizumab Compared to Pembrolizumab in Participants With Untreated Lung Cancer

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ClinicalTrials.gov Identifier: NCT04746924
Recruitment Status : Recruiting
First Posted : February 10, 2021
Last Update Posted : November 3, 2021
Sponsor:
Information provided by (Responsible Party):
BeiGene

Tracking Information
First Submitted Date  ICMJE February 5, 2021
First Posted Date  ICMJE February 10, 2021
Last Update Posted Date November 3, 2021
Actual Study Start Date  ICMJE June 8, 2021
Estimated Primary Completion Date November 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 5, 2021)
  • Progression-free Survival (PFS) As Assessed By Investigators [ Time Frame: Up to approximately 39 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.
  • Overall Survival (OS) As Assessed By Investigators [ Time Frame: Up to approximately 39 months ]
    OS will be defined as the time from the date of randomization to the date of death due to any cause.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 10, 2021)
  • PFS As Assessed By A Blinded Independent Review Committee [ Time Frame: Up to approximately 39 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.
  • Overall Response Rate (ORR) As Assessed By Investigators [ Time Frame: Up to approximately 39 months ]
    ORR will be defined as the proportion of participants with a documented, confirmed complete response or partial response per RECIST v1.1.
  • Duration Of Response (DOR) As Assessed By Investigators [ Time Frame: Up to approximately 39 months ]
    DOR will be defined as the time from the first determination of an objective response per RECIST v1.1 until the first documentation of progression or death, whichever occurs first.
  • Health-related Quality Of Life (HRQoL): European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire Core 30 (EORTC QLQ-C30) [ Time Frame: Within 7 days after last dose ]
    HRQoL will be assessed via patient-reported outcomes (PRO) using the EORTC QLQ-C30. The EORTC QLQ-C30 (Version 3) uses for the questions 1 to 28 a 4-point scale. The scale scores from 1 to 4: 1 ("Not at all"), 2 ("A little"), 3 ("Quite a bit") and 4 ("Very much"). Half points are not allowed. The range is 3. For the raw score, less points are considered to have a better outcome. The EORTC QLQ-C30 (Version 3) uses for the questions 29 and 30 a 7-points scale. The scale scores from 1 to 7: 1 ("very poor") to 7 ("excellent"). Half points are not allowed. The range is 6. First of all, raw score has to be calculated with mean values. Afterwards linear transformation is performed to be comparable. More points are considered to have a better outcome
  • HRQoL: EORTC Lung Cancer Module Quality Of Life Questionnaire Lung Cancer 13 (QLQ-LC13) [ Time Frame: Within 7 days after last dose ]
    HRQoL will be assessed via PRO using the EORTC QLQ-LC13. The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13) A score of 1-4 will be administrated for each item in QLQ-LC13. The higher scores will indicate the worse outcomes.
  • HRQoL: The 5 Level EuroQol 5 Dimension (EQ-5D-5L) Questionnaire [ Time Frame: Within 7 days after last dose ]
    HRQoL will be assessed via PRO using the EQ-5D-5L. EQ-5D-5L - Is the EuroQol 5D-5L a descriptive system that comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state.
  • Time To Deterioration (TDD) [ Time Frame: Within 7 days after last dose ]
    TDD will be analyzed using the global health status of QLQ-C30 and will be defined as worsening scores for 2 consecutive assessments or 1 assessment followed by death from any cause.
  • 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).
Original Secondary Outcome Measures  ICMJE
 (submitted: February 5, 2021)
  • PFS As Assessed By A Blinded Independent Review Committee [ Time Frame: Up to approximately 39 months ]
    PFS will be determined.
  • Overall Response Rate (ORR) As Assessed By Investigators [ Time Frame: Up to approximately 39 months ]
    ORR will be defined as the proportion of participants with a documented, confirmed complete response or partial response per RECIST v1.1.
  • Duration Of Response (DOR) As Assessed By Investigators [ Time Frame: Up to approximately 39 months ]
    DOR will be defined as the time from the first determination of an objective response per RECIST v1.1 until the first documentation of progression or death, whichever occurs first.
  • Health-related Quality Of Life (HRQoL): European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) [ Time Frame: Within 7 days after last dose ]
    HRQoL will be assessed via patient-reported outcomes (PRO) using the EORTC QLQ-C30.
  • HRQoL: EORTC Lung Cancer Module Quality Of Life Questionnaire Lung Cancer 13 (QLQ-LC13) [ Time Frame: Within 7 days after last dose ]
    HRQoL will be assessed via PRO using the EORTC QLQ-LC13.
  • HRQoL: The 5 Level EuroQol 5 Dimension (EQ-5D-5L) Questionnaire [ Time Frame: Within 7 days after last dose ]
    HRQoL will be assessed via PRO using the EQ-5D-5L.
  • Time To Deterioration (TDD) [ Time Frame: Within 7 days after last dose ]
    TDD will be analyzed using the global health status of QLQ-C30 and will be defined as worsening scores for 2 consecutive assessments or 1 assessment followed by death from any cause.
  • 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).
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of Ociperlimab With Tislelizumab Compared to Pembrolizumab in Participants With Untreated Lung Cancer
Official Title  ICMJE A Phase 3, Randomized, Double-Blind Study of BGB-A1217, an Anti-TIGIT Antibody, in Combination With Tislelizumab Compared to Pembrolizumab in Patients With Previously Untreated, PD-L1-Selected, and Locally Advanced, Unresectable, or Metastatic Non-Small Cell Lung Cancer
Brief Summary The purpose of the study is to compare progression-free survival (PFS) between Arm A (ociperlimab in combination with tislelizumab) and Arm B (pembrolizumab in combination with placebo) as assessed by investigators according to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) and to compare overall survival (OS) between Arm A and Arm B.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Non-small Cell Lung Cancer
  • NSCLC
Intervention  ICMJE
  • Drug: Tislelizumab
    Tislelizumab is a monoclonal antibody formulated for intravenous injection.
    Other Name: BGB-A317
  • Drug: Ociperlimab
    Ociperlimab is a monoclonal antibody formulated for intravenous injection.
    Other Name: BGB-A1217
  • Drug: Pembrolizumab
    Pembrolizumab is a monoclonal antibody formulated for intravenous injection.
    Other Name: KEYTRUDA
  • Drug: Placebo
    Placebo infusions will consist of a sterile, normal saline solution.
Study Arms  ICMJE
  • Experimental: Arm A: Tislelizumab plus Ociperlimab
    Participants will receive tislelizumab 200 milligrams (mg) intravenously followed by ociperlimab 900 mg intravenously once every 3 weeks.
    Interventions:
    • Drug: Tislelizumab
    • Drug: Ociperlimab
  • Active Comparator: Arm B: Pembrolizumab plus Placebo
    Participants will receive pembrolizumab 200 mg intravenously followed by placebo intravenously once every 3 weeks.
    Interventions:
    • Drug: Pembrolizumab
    • Drug: Placebo
  • Placebo Comparator: Arm C: Tislelizumab plus Placebo
    Participants will receive tislelizumab 200 mg intravenously followed by placebo intravenously once every 3 weeks.
    Interventions:
    • Drug: Tislelizumab
    • Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: February 5, 2021)
605
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 2025
Estimated Primary Completion Date November 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Key Inclusion Criteria:

  1. Histologically or cytologically documented locally advanced or recurrent non-small cell lung cancer (NSCLC) that is not eligible for curative surgery and/or definitive radiotherapy with or without chemoradiotherapy, or metastatic-nonsquamous or squamous NSCLC.
  2. No prior systemic treatment for metastatic NSCLC.
  3. Agreement to provide archival tissue (formalin-fixed paraffin-embedded block containing tumor [preferred] or 6 to 15 freshly cut unstained slides) or fresh biopsy (if archival tissue is not available) for prospective central evaluation of programmed cell death ligand-1 (PD-L1) levels and retrospective analysis of other biomarkers.
  4. Tumors with PD-L1 tumor cell ≥ 50% expression as centrally determined.
  5. At least 1 measurable lesion as defined per RECIST v1.1.

Key Exclusion Criteria:

  1. Known sensitizing mutation in the epidermal growth factor receptor (EGFR) gene or an anaplastic lymphoma kinase fusion oncogene.
  2. Prior therapy with an anti-programmed cell death protein (anti-PD)-1, anti-PD-ligand (L)-1, anti-PD-ligand-2, anti-T-cell immunoglobulin and ITIM (anti-TIGIT) domain, or any other antibody or drug specifically targeting T-cell costimulation or checkpoint pathways.
  3. Active leptomeningeal disease or uncontrolled, untreated brain metastasis.
  4. Active autoimmune diseases or history of autoimmune diseases that may relapse.
  5. 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.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: BeiGene 1-877-828-5568 clinicaltrials@beigene.com
Listed Location Countries  ICMJE Australia,   China,   France,   Georgia,   Germany,   Korea, Republic of,   Netherlands,   Russian Federation,   Spain,   Taiwan,   Turkey,   Ukraine,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04746924
Other Study ID Numbers  ICMJE AdvanTIG-302
BGB-A317-A1217-302 ( Other Identifier: BeiGene )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Responsible Party BeiGene
Study Sponsor  ICMJE BeiGene
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account BeiGene
Verification Date November 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP