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A Study of Ociperlimab With Tislelizumab Compared to Pembrolizumab in Participants With Untreated 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: NCT04746924
Recruitment Status : Recruiting
First Posted : February 10, 2021
Last Update Posted : March 28, 2023
Sponsor:
Information provided by (Responsible Party):
BeiGene

Study Description
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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.

Condition or disease Intervention/treatment Phase
Non-small Cell Lung Cancer NSCLC Drug: Tislelizumab Drug: Ociperlimab Drug: Pembrolizumab Drug: Placebo Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 660 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 3, Randomized, Double-Blind Study of Ociperlimab, 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
Actual Study Start Date : June 8, 2021
Estimated Primary Completion Date : January 2025
Estimated Study Completion Date : May 2025

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: Tislelizumab plus Ociperlimab
Participants will receive tislelizumab 200 milligrams (mg) intravenously followed by ociperlimab 900 mg intravenously once every 3 weeks.
 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
Active Comparator: Arm B: Pembrolizumab plus Placebo
Participants will receive pembrolizumab 200 mg intravenously followed by placebo intravenously once every 3 weeks.
 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.
Placebo Comparator: Arm C: Tislelizumab plus Placebo
Participants will receive tislelizumab 200 mg intravenously followed by placebo intravenously once every 3 weeks.
 Drug: Tislelizumab
Tislelizumab is a monoclonal antibody formulated for intravenous injection.
Other Name: BGB-A317

Drug: Placebo
Placebo infusions will consist of a sterile, normal saline solution.


Outcome Measures
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Primary Outcome Measures :
  1. Progression-free Survival (PFS) As Assessed By Investigators [ Time Frame: Up to approximately 40 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.

  2. Overall Survival (OS) [ Time Frame: Up to approximately 40 months ]
    OS will be defined as the time from the date of randomization to the date of death due to any cause.


Secondary Outcome Measures :
  1. PFS As Assessed By A Blinded Independent Review Committee [ Time Frame: Up to approximately 40 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.

  2. Overall Response Rate (ORR) As Assessed By Investigators [ Time Frame: Up to approximately 40 months ]
    ORR will be defined as the proportion of participants with a documented, confirmed complete response or partial response per RECIST v1.1.

  3. Duration Of Response (DOR) As Assessed By Investigators [ Time Frame: Up to approximately 40 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.

  4. 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 permanent treatment discontinuation ]

    HRQoL will be assessed via patient-reported outcomes (PRO) using the EORTC QLQ-C30.

    The EORTC QLQ-C30 (Version 3) consists of Global health status/QoL (score range from 0=very poor to 7=excellent), 5 functioning scales (physical, role, emotional, cognitive, social), 8 symptom scales (fatigue, nausea/vomiting, pain, dyspnea, insomnia, constipation, diarrhea) and financial difficulties with scores ranging from 1 = "Not at all" to 4 = "Very much". For the global health status/QoL and functioning scales, higher scores indicate better outcomes and for symptom scales, lower scores indicate better outcomes.


  5. HRQoL: EORTC Lung Cancer Module Quality of Life Questionnaire Lung Cancer 13 (QLQ-LC13) HRQoL will be assessed via PRO using the EORTC QLQ-LC13. [ Time Frame: Within 7 days after permanent treatment discontinuation ]
    QLQ-LC13 consists of 10 scales, scores ranging from 1 = "not at all" to 4 = "very much", and 2 questions regarding use of pain medication (yes/no) and if yes, did it help (1 = "not at all" to 4 = "very much"). In symptom scales, lower scores indicate better outcomes.

  6. HRQoL: European Quality of Life-5 Level- 5 Dimension (EQ-5D-5L) Questionnaire [ Time Frame: Within 7 days after permanent treatment discontinuation ]
    HRQoL will be assessed via PRO using the EQ-5D-5L. The EQ-5D-5L comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression, and a visual analog scale (VAS). Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. The VAS records the respondent's self-rated health on a 0 to 100 scale, with 100 = "the best health you can imagine" and 0 = "'the worst health you can imagine". Lower scores in descriptive dimension indicate better HRQoL and higher VAS scores indicates better health state.

  7. Time To Deterioration (TTD) [ Time Frame: Within 7 days after permanent treatment discontinuation ]
    TTD will be analyzed using PRO scores, and will be defined as worsening scores of ≥10 points from baseline for 2 consecutive assessments or 1 assessment followed by death from any cause.

  8. 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).


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 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 or fresh biopsy (if archival tissue is not available).
  4. Tumors with PD-L1 expressed in ≥ 50% tumor cells.
  5. At least 1 measurable lesion as defined per RECIST v1.1.
  6. ECOG Performance Status ≤ 1.

Key Exclusion Criteria:

  1. Known mutations in the epidermal growth factor receptor (EGFR) gene, anaplastic lymphoma kinase (ALK) fusion oncogene, BRAF V600E, or ROS1.
  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.

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): NCT04746924


Contacts
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Contact: BeiGene 1-877-828-5568 clinicaltrials@beigene.com

Locations
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Sponsors and Collaborators
BeiGene
Investigators
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Principal Investigator: Shun Lu Shanghai Chest Hospital
Principal Investigator: Mark Socinski Advent Health Orlando
More Information
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Responsible Party: BeiGene
ClinicalTrials.gov Identifier: NCT04746924    
Other Study ID Numbers: AdvanTIG-302
BGB-A317-A1217-302 ( Other Identifier: BeiGene )
First Posted: February 10, 2021    Key Record Dates
Last Update Posted: March 28, 2023
Last Verified: March 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:
Locally Advanced
Unresectable
Metastatic
Tislelizumab
BGB-A317
 Ociperlimab
BGB-A1217
Pembrolizumab
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
Pembrolizumab
Tislelizumab
Antineoplastic Agents, Immunological
Antineoplastic Agents
Immune Checkpoint Inhibitors
Molecular Mechanisms of Pharmacological Action