Description:
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.
Title
- Brief Title: Tislelizumab Plus BGB-A1217 Versus Tislelizumab Versus Durvalumab When Co-administered With Concurrent Chemoradiotherapy (cCRT) in Lung Cancer
- Official Title: Phase 3, Randomized, Open Label Study to Compare Ociperlimab (BGB-A1217) Plus Tislelizumab (BGB-A317) Plus Concurrent Chemoradiotherapy (cCRT) Followed by Ociperlimab Plus Tislelizumab or Tislelizumab Plus cCRT Followed by Tislelizumab Versus cCRT Followed by Durvalumab in Previously Untreated, Locally Advanced, Unresectable Non-Small Cell Lung Cancer
Clinical Trial IDs
- ORG STUDY ID:
BGB-A317-A1217-301
- SECONDARY ID:
2020-004656-14
- NCT ID:
NCT04866017
Conditions
- Non Small Cell Lung Cancer
Interventions
Drug | Synonyms | Arms |
---|
Tislelizumab | BGB-A317 | Arm A: ociperlimab + tislelizumab + Concurrent Chemoradiotherapy (eCRT) |
Durvalumab | | Arm C: Concurrent Chemoradiotherapy (eCR) + durvalumab |
Chemotherapy | | Arm A: ociperlimab + tislelizumab + Concurrent Chemoradiotherapy (eCRT) |
Ociperlimab | BGB-A1217 | Arm A: ociperlimab + tislelizumab + Concurrent Chemoradiotherapy (eCRT) |
Purpose
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.
Trial Arms
Name | Type | Description | Interventions |
---|
Arm A: ociperlimab + tislelizumab + Concurrent Chemoradiotherapy (eCRT) | Experimental | 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 | - Tislelizumab
- Chemotherapy
- Ociperlimab
|
Arm B: tislelizumab + Concurrent Chemoradiotherapy (cCRT) | Active Comparator | 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 | |
Arm C: Concurrent Chemoradiotherapy (eCR) + durvalumab | Experimental | 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 | |
Eligibility Criteria
Key Inclusion Criteria:
1. 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).
2. Participant has newly diagnosed, histologically confirmed, locally advanced, Stage III
unresectable NSCLC.
3. Measurable disease as assessed by RECIST v1.1.
4. Eastern Co-operative Oncology Group (ECOG) Performance Status of 0 or 1.
5. Patients must have adequate organ function
Key Exclusion Criteria:
1. Any prior therapy for lung cancer, including but not limited to chemotherapy,
radiotherapy, targeted therapy, biologic therapy, or immunotherapy.
2. Any prior radiotherapy to the thorax, including radiotherapy to the esophagus,
mediastinum, or for breast cancer.
3. 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.
4. Diagnosed with NSCLC that harbors an EGFR-sensitizing mutation or ALK gene
translocation.
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 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: Other protocol Inclusion/Exclusion criteria may apply.
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Progression-Free Survival (PFS) in the Intent-to-treat (ITT) Analysis set as assessed by the Independent Review Committee (IRC) |
Time Frame: | Up to 16 months |
Safety Issue: | |
Description: | Time from the date of randomization to the date of first documentation of disease progression assessed |
Secondary Outcome Measures
Measure: | Overall Survival (OS) in ITT Set |
Time Frame: | Up to 16 months |
Safety Issue: | |
Description: | Time from the date of randomization until the date of death due to any cause |
Measure: | Progression-Free Survival (PFS) in the PD-L1-Positive Analysis Set as assessed by the IRC |
Time Frame: | Up to 16 months |
Safety Issue: | |
Description: | Time from the date of randomization to the date of first documentation of disease progression assessed |
Measure: | Overall Response Rate (ORR) in ITT Set |
Time Frame: | Up to 16 months |
Safety Issue: | |
Description: | Proportion of participants who achieve a complete response (CR) or partial response (PR) |
Measure: | Duration of Response (DOR) in ITT Set |
Time Frame: | Up to 16 months |
Safety Issue: | |
Description: | Time from the first determination of a confirmed objective response |
Measure: | time to death or distant metastasis (TTDM) in the Intent-to-treat (ITT) Analysis set as assessed by the investigator |
Time Frame: | Up to 16 months |
Safety Issue: | |
Description: | 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 |
Measure: | Number of participants experiencing Adverse Events (AEs) |
Time Frame: | Up to 16 months |
Safety Issue: | |
Description: | |
Measure: | Number of participants experiencing Serious Adverse Events (SAEs) |
Time Frame: | Up to 16 months |
Safety Issue: | |
Description: | |
Measure: | 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) |
Time Frame: | Up to 16 months |
Safety Issue: | |
Description: | 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. |
Measure: | Health Related Quality of Life (HRQoL) in the ITT set as assessed by Quality of Life Questionnaire-Lung Cancer 13 (QLQ-LC13) |
Time Frame: | Up to 16 months |
Safety Issue: | |
Description: | 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. |
Measure: | Health Related Quality of Life (HRQoL) in the ITT set as assessed by European Quality of Life-5 Dimensions (EQ-5D-5L) |
Time Frame: | Up to 16 months |
Safety Issue: | |
Description: | 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. |
Measure: | Serum concentration of BGB-A1217 |
Time Frame: | Up to 30 minutes postdose |
Safety Issue: | |
Description: | |
Measure: | Serum concentration of Tislelizumab |
Time Frame: | Up to 30 minutes postdose |
Safety Issue: | |
Description: | |
Measure: | Immunogenic responses to BGB-A1217 as assessed by the detection of anti-drug antibodies (ADAs) |
Time Frame: | Up to 16 months |
Safety Issue: | |
Description: | |
Measure: | Immunogenic responses to Tislelizumab as assessed by the detection of anti-drug antibodies (ADAs) |
Time Frame: | Up to 16 months |
Safety Issue: | |
Description: | |
Measure: | Evaluate PD-L1 and TIGIT expression in archival and/or fresh tumor tissues |
Time Frame: | Up to 16 months |
Safety Issue: | |
Description: | before study treatment or at disease progression/reoccurrence, and their association with clinical efficacy. |
Measure: | Complete Response Rate (CRR) in the Intent-to-treat (ITT) Analysis set as assessed by the investigator |
Time Frame: | Up to 16 months |
Safety Issue: | |
Description: | defined as the proportion of patients who achieve a CR |
Details
Phase: | Phase 3 |
Primary Purpose: | Interventional |
Overall Status: | Recruiting |
Lead Sponsor: | BeiGene |
Last Updated
July 1, 2021