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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT04746924
Registration number
NCT04746924
Ethics application status
Date submitted
5/02/2021
Date registered
10/02/2021
Titles & IDs
Public title
A Study of Ociperlimab With Tislelizumab Compared to Pembrolizumab in Participants With Untreated Lung Cancer
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Scientific 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
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Secondary ID [1]
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BGB-A317-A1217-302
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Secondary ID [2]
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AdvanTIG-302
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Non-small Cell Lung Cancer
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NSCLC
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Condition category
Condition code
Cancer
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Lung - Mesothelioma
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Cancer
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Lung - Non small cell
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Cancer
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Lung - Small cell
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Tislelizumab
Treatment: Drugs - Ociperlimab
Treatment: Drugs - Pembrolizumab
Treatment: Drugs - Placebo
Experimental: Arm A: Tislelizumab plus Ociperlimab - Participants will receive tislelizumab 200 milligrams (mg) intravenously followed by ociperlimab 900 mg intravenously once every 3 weeks.
Active comparator: Arm B: Pembrolizumab plus Placebo - Participants will receive pembrolizumab 200 mg intravenously followed by placebo intravenously once every 3 weeks.
Placebo comparator: Arm C: Tislelizumab plus Placebo - Participants will receive tislelizumab 200 mg intravenously followed by placebo intravenously once every 3 weeks.
Treatment: Drugs: Tislelizumab
Tislelizumab is a monoclonal antibody formulated for intravenous injection.
Treatment: Drugs: Ociperlimab
Ociperlimab is a monoclonal antibody formulated for intravenous injection.
Treatment: Drugs: Pembrolizumab
Pembrolizumab is a monoclonal antibody formulated for intravenous injection.
Treatment: Drugs: Placebo
Placebo infusions will consist of a sterile, normal saline solution.
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Overall Survival (OS)
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Assessment method [1]
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OS will be defined as the time from the date of randomization to the date of death due to any cause.
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Timepoint [1]
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Up to approximately 58 months
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Secondary outcome [1]
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Progression-free Survival (PFS) As Assessed By Investigators
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Assessment method [1]
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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.
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Timepoint [1]
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Up to approximately 58 months
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Secondary outcome [2]
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Overall Response Rate (ORR) As Assessed By Investigators
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Assessment method [2]
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ORR will be defined as the proportion of participants with a documented, confirmed complete response or partial response per RECIST v1.1.
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Timepoint [2]
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Up to approximately 58 months
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Secondary outcome [3]
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Duration Of Response (DOR) As Assessed By Investigators
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Assessment method [3]
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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.
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Timepoint [3]
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Up to approximately 58 months
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Secondary outcome [4]
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Health-related Quality Of Life (HRQoL): European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire Core 30 (EORTC QLQ-C30)
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Assessment method [4]
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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.
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Timepoint [4]
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Within 7 days after permanent treatment discontinuation
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Secondary outcome [5]
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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.
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Assessment method [5]
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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.
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Timepoint [5]
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Within 7 days after permanent treatment discontinuation
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Secondary outcome [6]
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HRQoL: European Quality of Life-5 Level- 5 Dimension (EQ-5D-5L) Questionnaire
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Assessment method [6]
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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.
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Timepoint [6]
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Within 7 days after permanent treatment discontinuation
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Secondary outcome [7]
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Time To Deterioration (TTD)
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Assessment method [7]
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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.
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Timepoint [7]
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Within 7 days after permanent treatment discontinuation
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Secondary outcome [8]
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Number Of Participants Experiencing Adverse Events (AEs)
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Assessment method [8]
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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).
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Timepoint [8]
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90 days (±14) after last dose
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Eligibility
Key inclusion criteria
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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.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Active, not recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
8/06/2021
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/10/2026
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Actual
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Sample size
Target
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Accrual to date
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Final
662
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Recruitment in Australia
Recruitment state(s)
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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Virginia
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
BeiGene
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
The purpose of this study is to evaluate the efficacy and safety of ociperlimab + tislelizumab compared with that of pembrolizumab in adults with PD-L1 high, locally advanced/recurrent or untreated metastatic NSCLC.
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Trial website
https://clinicaltrials.gov/study/NCT04746924
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Trial related presentations / publications
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Public notes
This record is viewable in the ANZCTR as it had previously listed Australia and/or New Zealand as a recruitment site, however these sites have since been removed
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Contacts
Principal investigator
Name
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Shun Lu
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Address
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Shanghai Chest Hospital
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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BeiGene
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Address
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Country
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Phone
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1-877-828-5568
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
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When will data be available (start and end dates)?
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Available to whom?
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Available for what types of analyses?
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How or where can data be obtained?
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT04746924