Tislelizumab Plus BGB-A1217 Versus Tislelizumab Versus Durvalumab When Co-administered With Concurrent Chemoradiotherapy (cCRT) in Lung Cancer
Study Details
Study Description
Brief Summary
The primary objectives of this study is to compare progression free survival (PFS) and complete response rate (CRR) between participants treated with Ociperlimab plus tislelizumab plus Concurrent Chemoradiotherapy (cCRT) followed by Ociperlimab plus tislelizumab versus participants treated with tislelizumab plus Concurrent Chemoradiotherapy (cCRT) followed by tislelizumab versus participants treated with cCRT followed by durvalumab in previously untreated, locally advanced, unresectable non-small cell lung cancer (LA NSCLC) The secondary objective of this study is to compare overall survival (OS) and PFS in programmed cell death protein ligand-1 (PD-L1) positive population between Arm A and C.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 3 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Arm A: ociperlimab + tislelizumab + Concurrent Chemoradiotherapy (eCRT) Two cycles of ociperlimab (900 mg intravenously [IV]) combined with tislelizumab (200 mg IV) every 3 weeks (Q3W) with cCRT, followed by ociperlimab 900 mg IV combined with tislelizumab 200 mg IV Q3W up to 1 year after the cCRT phase |
Drug: Tislelizumab
100 mg/10 mL. 200 mg Q3W administered by intravenous infusion
Other Names:
Drug: Chemotherapy
Cisplatin, carboplatin, etoposide, paclitaxel, pemetrexed will be administered in accordance with the relevant local guidelines and/or prescribing information/summary of product characteristics
Drug: Ociperlimab
300 mg/15 mL. 900 mg Q3W administered by intravenous infusion
Other Names:
|
| Active Comparator: Arm B: tislelizumab + Concurrent Chemoradiotherapy (cCRT) Two cycles of tislelizumab 200 mg IV Q3W combined with cCRT, followed by tislelizumab 200 mg IV Q3W up to 1 year after the cCRT phase |
Drug: Tislelizumab
100 mg/10 mL. 200 mg Q3W administered by intravenous infusion
Other Names:
Drug: Chemotherapy
Cisplatin, carboplatin, etoposide, paclitaxel, pemetrexed will be administered in accordance with the relevant local guidelines and/or prescribing information/summary of product characteristics
|
| Experimental: Arm C: Concurrent Chemoradiotherapy (eCR) + durvalumab Comparator: Arm C: Concurrent Chemoradiotherapy (cCRT) followed by durvalumab Two cycles of cCRT, followed by durvalumab 10 mg/kg IV once every 2 weeks (Q2W) (or 1500 mg Q4W where the dosage has been approved by a local health authority) up to 1 year after the cCRT phase |
Drug: Durvalumab
120 mg/2.4 mL (50 mg/mL) and 500 mg/10 mL (50 mg/mL). 10 mg/kg Q2W (or 1500 mg Q4W where the dosage has been approved by a local health authority)
Drug: Chemotherapy
Cisplatin, carboplatin, etoposide, paclitaxel, pemetrexed will be administered in accordance with the relevant local guidelines and/or prescribing information/summary of product characteristics
|
Outcome Measures
Primary Outcome Measures
- Progression-Free Survival (PFS) in the Intent-to-treat (ITT) Analysis set as assessed by the Independent Review Committee (IRC) [Up to 16 months]
Time from the date of randomization to the date of first documentation of disease progression assessed
- Complete Response Rate (CRR) as assessed by the Independent Review Committee (IRC) [Up to 16 months]
defined as the proportion of patients who achieve a complete response (CR) per Repose Evaluation Criteria in Solid Tumors (RECIST) version 1.1 (v.1.1)
Secondary Outcome Measures
- Overall Survival (OS) in ITT Set [Up to 16 months]
Time from the date of randomization until the date of death due to any cause
- Progression-Free Survival (PFS) in the PD-L1-Positive Analysis Set as assessed by the IRC [Up to 16 months]
Time from the date of randomization to the date of first documentation of disease progression assessed
- Overall Response Rate (ORR) in ITT Set [Up to 16 months]
Proportion of participants who achieve a complete response (CR) or partial response (PR)
- Duration of Response (DOR) in ITT Set [Up to 16 months]
Time from the first determination of a confirmed objective response
- time to death or distant metastasis (TTDM) in the Intent-to-treat (ITT) Analysis set as assessed by the investigator [Up to 16 months]
Time from the date of randomization until the first date of distant metastasis or death in the absence of distant metastasis. Distant metastasis is defined as any new lesion that is outside of the radiation field
- Number of participants experiencing Adverse Events (AEs) [Up to 16 months]
- Number of participants experiencing Serious Adverse Events (SAEs) [Up to 16 months]
- Health Related Quality of Life (HRQoL) in the ITT set as assessed by European Organisation for Research and Treatment of Cancer Quality-of-life Questionnaire Core 30 (EORTC-QLQ-C30) [Up to 16 months]
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.
- Health Related Quality of Life (HRQoL) in the ITT set as assessed by Quality of Life Questionnaire-Lung Cancer 13 (QLQ-LC13) [Up to 16 months]
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.
- Health Related Quality of Life (HRQoL) in the ITT set as assessed by European Quality of Life-5 Dimensions (EQ-5D-5L) [Up to 16 months]
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 patient 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 patient's health state.
- Serum concentration of BGB-A1217 [Up to 30 minutes postdose]
- Serum concentration of Tislelizumab [Up to 30 minutes postdose]
- Immunogenic responses to BGB-A1217 as assessed by the detection of anti-drug antibodies (ADAs) [Up to 16 months]
- Immunogenic responses to Tislelizumab as assessed by the detection of anti-drug antibodies (ADAs) [Up to 16 months]
- Evaluate PD-L1 and TIGIT expression in archival and/or fresh tumor tissues [Up to 16 months]
before study treatment or at disease progression/reoccurrence, and their association with clinical efficacy.
- Complete Response Rate (CRR) in the Intent-to-treat (ITT) Analysis set as assessed by the investigator [Up to 16 months]
defined as the proportion of patients who achieve a CR
Eligibility Criteria
Criteria
Key Inclusion Criteria:
-
Age ≥ 18 years on the day of signing the ICF (or the legal age of consent in the jurisdiction in which the study is taking place).
-
Participant has newly diagnosed, histologically confirmed, locally advanced, Stage III unresectable NSCLC.
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Measurable disease as assessed by RECIST v1.1.
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Eastern Co-operative Oncology Group (ECOG) Performance Status of 0 or 1.
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Patients must have adequate organ function
Key Exclusion Criteria:
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Any prior therapy for lung cancer, including but not limited to chemotherapy, radiotherapy, targeted therapy, biologic therapy, or immunotherapy.
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Any prior radiotherapy to the thorax, including radiotherapy to the esophagus, mediastinum, or for breast cancer.
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Prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2, TIGIT or any other antibody or drug specifically targeting T-cell costimulation or checkpoint pathways.
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Diagnosed with NSCLC that harbors an EGFR-sensitizing mutation or ALK gene translocation.
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Active autoimmune diseases or history of autoimmune diseases that may relapse.
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Any condition that required systemic treatment with either corticosteroids (> 10 mg daily of prednisone or equivalent) or other immunosuppressive medication ≤ 14 days before the first dose of study treatment.
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Infection (including tuberculosis infection, etc) requiring systemic antibacterial, antifungal or antiviral therapy within 14 days before the first dose of study treatment.
NOTE: Other protocol Inclusion/Exclusion criteria may apply.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | XCancer/Centeral Care Center | Bolivar | Missouri | United States | 65613 |
| 2 | Southern Medical Day Care Centre | Wollongong | New South Wales | Australia | NSW 2500 |
| 3 | Townsville Hospital | Douglas | Queensland | Australia | 4814 |
| 4 | Lyell McEwin Hospital | Elizabeth Vale | South Australia | Australia | 5112 |
| 5 | Royal Hobart Hospital | Hobart | Tasmania | Australia | |
| 6 | Cabrini Hospital | Malvern | Victoria | Australia | 3144 |
| 7 | Gold Coast University Hospital | Gold Coast | Australia | 4215 | |
| 8 | Hollywood Private Hospital | Perth | Australia |
Sponsors and Collaborators
- BeiGene
Investigators
- Study Director: Yalan Yang, MD, BeiGene
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- BGB-A317-A1217-301
- 2020-004656-14