Clinical Trials /

A Study of BGB-A1217 With Tislelizumab Compared to Pembrolizumab in Participants With Untreated Lung Cancer

NCT04746924

Description:

The purpose of the study is to compare progression-free survival (PFS) between Arm A (BGB-A1217 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.

Related Conditions:
  • Non-Small Cell Lung Carcinoma
  • Non-Squamous Non-Small Cell Lung Carcinoma
Recruiting Status:

Not yet recruiting

Phase:

Phase 3

Trial Eligibility

Document

Title

  • Brief Title: A Study of BGB-A1217 With Tislelizumab Compared to Pembrolizumab in Participants With Untreated Lung Cancer
  • Official Title: 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

Clinical Trial IDs

  • ORG STUDY ID: BGB-A317-A1217-302
  • NCT ID: NCT04746924

Conditions

  • Non-small Cell Lung Cancer
  • NSCLC

Interventions

DrugSynonymsArms
TislelizumabBGB-A317Arm A: Tislelizumab plus BGB-A1217
BGB-A1217OciperlimabArm A: Tislelizumab plus BGB-A1217
PembrolizumabKEYTRUDAArm B: Pembrolizumab plus Placebo
PlaceboArm B: Pembrolizumab plus Placebo

Purpose

The purpose of the study is to compare progression-free survival (PFS) between Arm A (BGB-A1217 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.

Trial Arms

NameTypeDescriptionInterventions
Arm A: Tislelizumab plus BGB-A1217ExperimentalParticipants will receive tislelizumab 200 milligrams (mg) intravenously followed by BGB-A1217 900 mg intravenously once every 3 weeks.
  • Tislelizumab
  • BGB-A1217
Arm B: Pembrolizumab plus PlaceboActive ComparatorParticipants will receive pembrolizumab 200 mg intravenously followed by placebo intravenously once every 3 weeks.
  • Pembrolizumab
  • Placebo
Arm C: Tislelizumab plus PlaceboPlacebo ComparatorParticipants will receive tislelizumab 200 mg intravenously followed by placebo intravenously once every 3 weeks.
  • Tislelizumab
  • Placebo

Eligibility Criteria

        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.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Progression-free Survival (PFS) As Assessed By Investigators
Time Frame:Up to approximately 39 months
Safety Issue:
Description: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

Measure:PFS As Assessed By A Blinded Independent Review Committee
Time Frame:Up to approximately 39 months
Safety Issue:
Description:PFS will be determined.
Measure:Overall Response Rate (ORR) As Assessed By Investigators
Time Frame:Up to approximately 39 months
Safety Issue:
Description:ORR will be defined as the proportion of participants with a documented, confirmed complete response or partial response per RECIST v1.1.
Measure:Duration Of Response (DOR) As Assessed By Investigators
Time Frame:Up to approximately 39 months
Safety Issue:
Description: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.
Measure: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
Safety Issue:
Description:HRQoL will be assessed via patient-reported outcomes (PRO) using the EORTC QLQ-C30.
Measure:HRQoL: EORTC Lung Cancer Module Quality Of Life Questionnaire Lung Cancer 13 (QLQ-LC13)
Time Frame:Within 7 days after last dose
Safety Issue:
Description:HRQoL will be assessed via PRO using the EORTC QLQ-LC13.
Measure:HRQoL: The 5 Level EuroQol 5 Dimension (EQ-5D-5L) Questionnaire
Time Frame:Within 7 days after last dose
Safety Issue:
Description:HRQoL will be assessed via PRO using the EQ-5D-5L.
Measure:Time To Deterioration (TDD)
Time Frame:Within 7 days after last dose
Safety Issue:
Description: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.
Measure:Number Of Participants Experiencing Adverse Events (AEs)
Time Frame:90 days (±14) after last dose
Safety Issue:
Description: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).

Details

Phase:Phase 3
Primary Purpose:Interventional
Overall Status:Not yet recruiting
Lead Sponsor:BeiGene

Trial Keywords

  • Locally Advanced
  • Unresectable
  • Metastatic
  • Tislelizumab
  • BGB-A317
  • Ociperlimab
  • BGB-A1217
  • Pembrolizumab
  • Anti-TIGIT

Last Updated

February 10, 2021