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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT04866017
Registration number
NCT04866017
Ethics application status
Date submitted
28/10/2020
Date registered
29/04/2021
Date last updated
18/01/2024
Titles & IDs
Public title
A Study to Compare Ociperlimab Plus Tislelizumab Versus Durvalumab Following Concurrent Chemoradiotherapy (cCRT) in Patients With Stage III Unresectable Non-Small Cell Lung Cancer
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Scientific title
A Phase 3, Randomized, Open-Label Study to Compare Ociperlimab (BGB-A1217) Plus Tislelizumab (BGB-A317) Versus Durvalumab in Patients With Locally Advanced, Unresectable, PD-L1-Selected Non-Small Cell Lung Cancer Whose Disease Has Not Progressed After Concurrent Chemoradiotherapy
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Secondary ID [1]
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2020-004656-14
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Secondary ID [2]
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BGB-A317-A1217-301
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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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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 - Durvalumab
Treatment: Drugs - Ociperlimab
Experimental: Arm A: ociperlimab + tislelizumab - ociperlimab combined with tislelizumab every 3 weeks
Experimental: Arm B: tislelizumab - tislelizumab every 3 weeks
Experimental: Arm C: durvalumab - durvalumab every 2 weeks or 4 weeks
Treatment: Drugs: Tislelizumab
administered by intravenous infusion
Treatment: Drugs: Durvalumab
administered by intravenous infusion
Treatment: Drugs: Ociperlimab
administered by intravenous infusion
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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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Progression-Free Survival (PFS) as assessed by the Independent Review Committee (IRC)
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Assessment method [1]
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Time from the date of randomization to the date of first documentation of disease progression assessed by the IRC per RECIST v1.1 or death, whichever occurs first
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Timepoint [1]
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Up to 16 months
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Secondary outcome [1]
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Overall Survival (OS)
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Assessment method [1]
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defined as the time from the date of randomization until the date of death due to any cause
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Timepoint [1]
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Up to 16 months
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Secondary outcome [2]
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Overall Response Rate (ORR)
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Assessment method [2]
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defined as the proportion of participant who achieve a complete response (CR) or partial response (PR) assessed by both the IRC and investigators per RECIST v1.1
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Timepoint [2]
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Up to 16 months
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Secondary outcome [3]
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Duration of Response (DOR)
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Assessment method [3]
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defined as the time from the first determination of a confirmed objective response assessed by both the IRC and investigators per RECIST v1.1 until the first documentation of disease progression or death, whichever occurs first
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Timepoint [3]
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Up to 16 months
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Secondary outcome [4]
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Time to death or distant metastasis (TTDM) as assessed by the investigator
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Assessment method [4]
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defined as the time from the date of randomization until the first date of distant metastasis assessed by both the IRC and investigators, or death. Distant metastasis is defined as any new lesion that is outside of the radiation field per RECIST v1.1 or proven by biopsy.
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Timepoint [4]
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Up to 16 months
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Secondary outcome [5]
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Progression-Free Survival 2 (PFS2)
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Assessment method [5]
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defined as the time from randomization to the disease progression after next line of treatment, or death from any cause, whichever occurs first
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Timepoint [5]
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Up to 16 months
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Secondary outcome [6]
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Number of participants experiencing Adverse Events (AEs)
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Assessment method [6]
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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 [6]
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Up to 16 months
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Secondary outcome [7]
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Health Related Quality of Life (HRQoL) as assessed by European Organisation for Research and Treatment of Cancer Quality-of-life Questionnaire Core 30 (EORTC-QLQ-C30)
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Assessment method [7]
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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.
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Timepoint [7]
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Up to 16 months
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Secondary outcome [8]
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Health Related Quality of Life (HRQoL)as assessed by Quality of Life Questionnaire-Lung Cancer 13 (QLQ-LC13)
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Assessment method [8]
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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.
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Timepoint [8]
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Up to 16 months
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Secondary outcome [9]
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Health Related Quality of Life (HRQoL) as assessed by European Quality of Life-5 Dimensions (EQ-5D-5L)
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Assessment method [9]
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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 participant 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 participant's health state.
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Timepoint [9]
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Up to 16 months
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Secondary outcome [10]
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Serum concentration of ociperlimab
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Assessment method [10]
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Timepoint [10]
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Up to 30 minutes postdose
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Secondary outcome [11]
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Serum concentration of tislelizumab
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Assessment method [11]
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Timepoint [11]
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Up to 30 minutes postdose
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Secondary outcome [12]
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Immunogenic responses to BGB-A1217 as assessed by the detection of anti-drug antibodies (ADAs)
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Assessment method [12]
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Timepoint [12]
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Up to 16 months
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Secondary outcome [13]
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Immunogenic responses to Tislelizumab as assessed by the detection of anti-drug antibodies (ADAs)
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Assessment method [13]
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Timepoint [13]
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Up to 16 months
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Secondary outcome [14]
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Evaluate PD-L1 and TIGIT expression in archival and/or fresh tumor tissues
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Assessment method [14]
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before study treatment or at disease progression/reoccurrence, and their association with clinical efficacy.
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Timepoint [14]
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Up to 16 months
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Eligibility
Key inclusion criteria
Key
1. Age = 18 years on the day of signing the informed consent form (or the legal age of
consent in the jurisdiction in which the study is taking place).
2. Participant has histologically or cytologically confirmed, locally advanced,
unresectable Stage III NSCLC (AJCC Cancer Staging Manual 2017, derived from IASLC)
prior to initiation of cCRT.
3. Participant must have completed at least 2 cycles of platinum-based chemotherapy
concurrent with radiotherapy
4. Participants must have not experienced PD following definitive, platinum-based cCRT.
5. Eastern Co-operative Oncology Group (ECOG) Performance Status of 0 or 1.
6. Participants must have adequate organ function
7. Agree to provide archival tissue (formalin-fixed paraffin-embedded block containing
tumor [preferred] or approximately 6 to 15 freshly cut unstained slides) or fresh
biopsy obtained prior to cCRT (if archival tissue is not available) for prospective
central evaluation of PD-L1 levels and retrospective analysis of other biomarkers.
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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. Prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2, TIGIT, or any other antibody
or drugs specifically targeting T-cell co-stimulation or checkpoint pathways.
2. Diagnosed with NSCLC that harbors an epidermal growth factor receptor (EGFR)
sensitizing mutation, anaplastic lymphoma kinase (ALK) gene translocation, ROS1 gene
translocation or RET gene rearrangement.
3. Participants who received systemic anticancer treatment besides the specified cCRT.
4. Any unresolved toxicity CTCAE > Grade 2 from the prior cCRT.
5. Active autoimmune diseases or history of autoimmune diseases that may relapse.
6. Any condition that required systemic treatment with either corticosteroids (> 10 mg
daily of prednisone [in Japan, prednisolone] or equivalent) or other immunosuppressive
medication = 14 days before the first dose of study treatment.
7. Infection (including tuberculosis infection, etc) requiring systemic antibacterial,
antifungal, or antiviral therapy within 14 days before the first dose of study
treatment.
Note: Antiviral therapy is permitted for participants with chronic hepatitis B virus (HBV)
or hepatitis C virus (HCV) infection.
NOTE: Other protocol 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
Open (masking not used)
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Who is / are masked / blinded?
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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
Terminated
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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
17/06/2021
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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
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Actual
17/10/2023
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Sample size
Target
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Accrual to date
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Final
63
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,TAS,VIC
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Recruitment hospital [1]
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Southern Medical Day Care Centre - Wollongong
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Recruitment hospital [2]
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Townsville Hospital - Douglas
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Recruitment hospital [3]
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Lyell McEwin Hospital - Elizabeth Vale
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Recruitment hospital [4]
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Royal Hobart Hospital - Hobart
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Recruitment hospital [5]
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Cabrini Hospital - Malvern
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Recruitment hospital [6]
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Gold Coast University Hospital - Gold Coast
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Recruitment hospital [7]
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Hollywood Private Hospital - Perth
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Recruitment postcode(s) [1]
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NSW 2500 - Wollongong
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Recruitment postcode(s) [2]
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4814 - Douglas
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Recruitment postcode(s) [3]
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5112 - Elizabeth Vale
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Recruitment postcode(s) [4]
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- Hobart
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Recruitment postcode(s) [5]
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3144 - Malvern
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Recruitment postcode(s) [6]
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4215 - Gold Coast
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Recruitment postcode(s) [7]
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- Perth
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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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Missouri
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Country [2]
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China
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State/province [2]
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Beijing
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Country [3]
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China
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State/province [3]
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Chongqing
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Country [4]
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China
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State/province [4]
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Fujian
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Country [5]
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China
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State/province [5]
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Guangdong
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Country [6]
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China
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State/province [6]
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Hunan
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Country [7]
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China
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State/province [7]
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Jiangsu
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Country [8]
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China
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State/province [8]
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Jiangxi
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Country [9]
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China
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State/province [9]
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Jilin
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Country [10]
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China
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State/province [10]
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Ningxia
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Country [11]
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China
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State/province [11]
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Shandong
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Country [12]
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China
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State/province [12]
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Shanghai
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Country [13]
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China
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State/province [13]
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Sichuan
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China
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State/province [14]
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Tianjin
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Country [15]
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China
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State/province [15]
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Zhejiang
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Country [16]
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China
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State/province [16]
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Changzhou
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Country [17]
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China
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State/province [17]
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Jieyang
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Country [18]
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Taiwan
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State/province [18]
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Changhua
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Country [19]
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Taiwan
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State/province [19]
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Taichung
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Country [20]
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Taiwan
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State/province [20]
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Taipei
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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 primary objective of this study is to compare progression-free survival (PFS) between Arm
A (ociperlimab in combination with tislelizumab) and Arm C (Durvalumab) as assessed by the
Independent Review Committee (IRC) per Response Evaluation Criteria in Solid Tumors Version
1.1 (RECIST v1.1) in participants with stage III unresectable PD-L1-selected non-small cell
lung cancer whose disease has not progressed after cCRT.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT04866017
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Address
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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
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT04866017
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