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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/NCT03745222
Registration number
NCT03745222
Ethics application status
Date submitted
9/11/2018
Date registered
19/11/2018
Date last updated
15/07/2020
Titles & IDs
Public title
A Study of Tislelizumab (BGB-A317) Plus Chemoradiotherapy Followed by Tislelizumab Monotherapy in Newly Diagnosed, Stage III Subjects With Locally Advanced, Unresectable Non-small Cell Lung Cancer
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Scientific title
A PHASE 3, RANDOMIZED, BLINDED, PLACEBO-CONTROLLED STUDY OF TISLELIZUMAB (BGB-A317) PLUS CHEMORADIOTHERAPY FOLLOWED BY TISLELIZUMAB MONOTHERAPY IN NEWLY DIAGNOSED, STAGE III SUBJECTS WITH LOCALLY ADVANCED, UNRESECTABLE NON-SMALL CELL LUNG CANCER
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Secondary ID [1]
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U1111-1216-4294
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Secondary ID [2]
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BGB-A317-NSCL-001
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Universal Trial Number (UTN)
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Trial acronym
RATIONALE001
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Carcinoma, Non-Small-Cell Lung
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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 - Concurrent chemoradiotherapy (cCRT)
Other interventions - Placebo
Experimental: Arm 1:Tislelizumab + cCRT followed by tislelizumab monotherapy - Tislelizumab 200 mg is administered by intravenous (IV) administration and given together upfront with concurrent platinum-based chemoradiotherapy (cCRT) for the first 6 weeks, followed by tislelizumab 200 mg by IV adminstration monotherapy. The standard platinum-based chemotherapy options include carboplatin/ paclitaxel and cisplatin/etoposide
Experimental: Arm 2: Placebo + cCRT followed by tislelizumab monotherapy - Placebo is given with concurrent platinum-based chemoradiotherapy (cCRT) for the first 6 weeks, followed by tislelizumab 200 mg by IV administration monotherapy. The standard platinum-based chemotherapy options include carboplatin/paclitaxel and cisplatin/etoposide.
Placebo Comparator: Arm 3: Placebo + cCRT followed by placebo monotherapy - Placebo is given with concurrent platinum-based chemoradiotherapy (cCRT) for the first 6 weeks, followed by placebo monotherapy. The standard platinum-based chemotherapy options include carboplatin/paclitaxel and cisplatin/etoposide.
Treatment: Drugs: Tislelizumab
PD-1 inhibitor (monoclonal antibody against PD-1)
Treatment: Drugs: Concurrent chemoradiotherapy (cCRT)
Chemotherapy options include carboplatin/paclitaxel and cisplatin/etoposide per standard of care. Radiotherapy will also be given concurrently with chemotherapy.
Other interventions: Placebo
Placebo
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Intervention code [1]
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Treatment: Drugs
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Intervention code [2]
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Other interventions
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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)
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Assessment method [1]
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Progression-free survival was defined as the time from the date of randomization to the date of the first objectively tumor progression as assessed by the blinded independent central review per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 criteria (documented by radiological assessment) or death (any cause) on or prior to the clinical cut-off date, which ever occurred first. Stable disease-neither sufficient shrinkage to qualify for PR nor sufficient increase of lesions to qualify for Progressive disease (PD)• Progressive Disease- At least a 20% increase in the sum of diameters of target lesions from nadir.
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Timepoint [1]
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Up to approximately 5 years; date of randomization to the date of tumor progression or death; until study withdrawal date of 26 June 2019
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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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Overall survival was defined as the time between randomization of treatment and death from any cause.
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Timepoint [1]
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Up to approximately 5 years; date of randomization to date of death from any cause.
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Secondary outcome [2]
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Overall Survival at 24 Months
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Assessment method [2]
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Overall survival was defined as the time between randomization of treatment and death from any cause.
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Timepoint [2]
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Up to approximately 24 months
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Secondary outcome [3]
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Percentage of Participants Who Achieved a Best Overall Response of Complete Response or Partial Response
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Assessment method [3]
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Overall Response was defined as percentage of participants who had a radiologic confirmed complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1) guidelines, between Day 1 of treatment and subsequent anti-cancer therapy, death or study discontinuation. Complete response was defined as the disappearance of all target lesions; partial response (PR) is defined as at least a 30% decrease in the sum of diameters of target lesions from baseline; stable disease-neither sufficient shrinkage to qualify for PR nor sufficient increase of lesions to qualify for progressive disease (PD).
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Timepoint [3]
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Up to approximately 5 years
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Secondary outcome [4]
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Duration of Response
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Assessment method [4]
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Duration of Response is defined as the time from the first occurrence of a documented objective response to the time of relapse, as determined by blinded independent central review per RECIST v1.1, or death from any cause, whichever comes first.
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Timepoint [4]
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Up to approximately 5 years
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Secondary outcome [5]
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Percentage of Participants Alive and Progression-Free at 12 Months (APF12)
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Assessment method [5]
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Progression-free survival was defined as the time from the date of randomization to the date of the first objectively tumor progression as assessed by the blinded independent central review per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 criteria (documented by radiological assessment) or death (any cause) on or prior to the clinical cut-off date, which ever occurred first
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Timepoint [5]
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Up to 12 months
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Secondary outcome [6]
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Percentage of Participants Alive and Progression-free at 18 Months (APF18)
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Assessment method [6]
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Progression-free survival was defined as the time from the date of randomization to the date of the first objectively tumor progression as assessed by the blinded independent central review per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 criteria (documented by radiological assessment) or death (any cause) on or prior to the clinical cut-off date, which ever occurred first
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Timepoint [6]
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Up to approximately 18 months
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Secondary outcome [7]
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Time to Distant Metastasis (TTDM)
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Assessment method [7]
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TTDM was defined as the time from the date of randomization until the first date of distant metastasis or death in the absence of distant metastasis. Distant metastasis was defined as any new lesion that is outside of the radiation field according to RECIST v1.1 or proven by biopsy.
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Timepoint [7]
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Up to approximately 5 years
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Secondary outcome [8]
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Number of Participants With Treatment Emergent Adverse Events (TEAEs)
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Assessment method [8]
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TEAEs include any adverse events (AEs) that had an onset date or a worsening in severity from baseline on or after the first dose of study drug up to 30 days following study drug discontinuation or initiation of new anticancer therapy, whichever occurred first. TEAEs also included all immune-related AEs recorded up to 90 days after the last dose of tislelizumab or placebo, regardless of whether or not the particpant started a new anticancer therapy. In addition, any serious AE with an onset date more than 30 days after the last dose of study drug that is assessed by the investigator as related to study drug were considered a TEAE."
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Timepoint [8]
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From first dose of study drug up to study withdrawal date of 26 June 2019; 15 days.
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Secondary outcome [9]
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Number of Participants With Lung Cancer Symptoms Assessed by the Corresponding Domains of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC-QLQ-C30) and Lung-Cancer Specific QLQ-LC13
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Assessment method [9]
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The EORTC QLQ-C30 is a 30-item, questionnaire assessing quality of life (QoL), psychosocial burden and physical symptoms. It is classified into 15 domains: 5 functional subscales (physical functioning, role functioning, emotional functioning, cognitive functioning, and social functioning); 3 multi-item symptom subscales (fatigue, nausea/vomiting, and pain); each item is measured on a 4 point response scale; (not at all, a little, quite a bit, very much), with the exception of the 2 items measuring global health and QoL, (measured on a 7-point response scale). Scores are linearly transformed to 0 to 100 scores. Scores vary from 0 (worst) to 100 (best) for the functional dimensions and GHS, and from 0 (best) to 100 (worst) for the symptom dimensions; higher scores = better QoL, better functioning, or more severe symptoms, respectively. The LC13 covers 13 typical symptoms of lung cancer patients, such as coughing, pain, dyspnea, sore mouth, peripheral neuropathy, and hair loss.
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Timepoint [9]
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Up to approximately 5 years
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Secondary outcome [10]
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Percentage of Participants Who Would Have Continued on to Monotherapy Phase
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Assessment method [10]
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Included the percentage of participants who would have received at least one dose of tislelizumab or placebo in the monotherapy phase before progression.
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Timepoint [10]
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Up to approximately 5 years
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Eligibility
Key inclusion criteria
1. Newly diagnosed, histologically confirmed, locally advanced, stage III unresectable
non small cell lung cancer (NSCLC).
Staging will be confirmed at screening by positron emission tomography-computed
tomography (PET/CT) and brain imaging by magnetic resonance imaging (MRI) or computed
tomography (CT) with contrast.
2. Eastern Cooperative Oncology Group (ECOG) performance status = 1.
3. Epidermal growth factor receptor (EGFR) mutation and anaplastic lymphoma kinase (ALK)
gene translocation status available prior to randomization.
4. Provision of fresh or archival tumor tissue or discussion with Sponsor.
5. Adequate hematologic and end-organ function.
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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 therapies including those targeting PD-1 or PD-L1 or chemotherapy, radiation,
targeted therapy, biologic therapy, immunotherapy or investigational agent used to
control non-small cell lung cancer (NSCLC).
2. History of severe hypersensitivity reactions to other monoclonal antibodies or any
contraindication to the planned chemotherapy regimen.
3. History of, or ongoing, interstitial lung disease; pneumonitis requiring steroids; or
clinically significant pericardial effusion.
4. Any active malignancy less than or equal to 2 years before randomization, with the
exception of non-small cell lung cancer (NSCLC) and any locally recurring cancer that
has been treated curatively.
5. Severe chronic or active infections including those requiring systemic antibacterial,
antifungal or antiviral therapy; known human immunodeficiency virus (HIV) infection;
untreated chronic hepatitis B or chronic hepatitis B virus carries or active hepatitis
C; or active autoimmune disease.
6. Prior allogeneic stem cell transplantation or organ transplantation.
7. Significant cardiovascular disease or other condition which places the patient at
risk.
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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 assessing the outcomes
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
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
22/05/2019
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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
26/06/2019
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Sample size
Target
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Accrual to date
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Final
1
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Recruitment in Australia
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Recruitment outside Australia
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Portugal
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State/province [98]
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Amadora
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Portugal
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Coimbra
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Portugal
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Guimaraes
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Portugal
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Lisboa
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Portugal
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Porto
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Romania
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State/province [103]
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Bucharest
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Romania
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State/province [104]
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Cluj-Napoca
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Romania
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Constanta
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Romania
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State/province [106]
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Craiova
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Country [107]
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Romania
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State/province [107]
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Timisoara
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Country [108]
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Russian Federation
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State/province [108]
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Moscow
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Country [109]
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Russian Federation
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Omsk
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Country [110]
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Russian Federation
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State/province [110]
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Ryazan
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Country [111]
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Russian Federation
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State/province [111]
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Saransk
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Country [112]
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Russian Federation
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State/province [112]
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St. Petersburg
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Country [113]
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Singapore
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State/province [113]
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Singapore
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Country [114]
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Spain
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State/province [114]
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A Coruna
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Country [115]
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Spain
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State/province [115]
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Alicante
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Country [116]
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Spain
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State/province [116]
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Barcelona
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Country [117]
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Spain
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State/province [117]
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Las Palmas de Gran Canaria
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Country [118]
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Spain
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State/province [118]
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Madrid
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Spain
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Majadahonda, Madrid
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Country [120]
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Spain
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Malaga
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Country [121]
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Spain
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Oviedo
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Spain
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State/province [122]
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Valencia
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Taiwan
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State/province [123]
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Dalin
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Country [124]
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Taiwan
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State/province [124]
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Kaohsiung, San Ming Dist.
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Country [125]
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Taiwan
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State/province [125]
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Kaohsiung
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Taiwan
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Niao-Sung Hsiang Kaohsiung County
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Taiwan
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State/province [127]
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Taipei, Zhongzheng Dist.
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Country [128]
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United Kingdom
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State/province [128]
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Birmingham
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Country [129]
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United Kingdom
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State/province [129]
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Colchester
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Country [130]
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United Kingdom
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London
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Country [131]
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United Kingdom
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State/province [131]
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Maidstone
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Country [132]
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United Kingdom
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State/province [132]
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Manchester
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Country [133]
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United Kingdom
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State/province [133]
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Northwood
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Country [134]
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United Kingdom
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Sheffield South Yorkshire
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Country [135]
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United Kingdom
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State/province [135]
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Truro
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Celgene
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Address
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Other collaborator category [1]
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Commercial sector/Industry
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Name [1]
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BeiGene
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Ethics approval
Ethics application status
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Summary
Brief summary
This is a Phase 3, randomized, double-blind, placebo-controlled multicenter global study
designed to compare the efficacy and safety of tislelizumab in combination with concurrent
chemoradiotherapy (cCRT) followed by tislelizumab monotherapy versus cCRT alone, and
tislelizumab given sequentially after cCRT versus cCRT alone, in newly diagnosed stage III
subjects with locally advanced, unresectable non-small cell lung cancer (NSCLC). The primary
endpoint is centrally-assessed progression free survival (PFS) in the intent-to-treat (ITT)
population. .
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Trial website
https://clinicaltrials.gov/ct2/show/NCT03745222
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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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Marie Nguyen, MD
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Address
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Celgene
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT03745222
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