Description:
The purpose of the study is to compare progression-free survival (PFS) between Arm A
(ociperlimab in combination with tislelizumab) and Arm B (pembrolizumab in combination with
placebo) as assessed by investigators according to Response Evaluation Criteria in Solid
Tumors Version 1.1 (RECIST v1.1) and to compare overall survival (OS) between Arm A and Arm
B.
Title
- Brief Title: A Study of Ociperlimab With Tislelizumab Compared to Pembrolizumab in Participants With Untreated Lung Cancer
- Official Title: A Phase 3, Randomized, Double-Blind Study of BGB-A1217, 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
Clinical Trial IDs
- ORG STUDY ID:
AdvanTIG-302
- NCT ID:
NCT04746924
Conditions
- Non-small Cell Lung Cancer
- NSCLC
Interventions
Drug | Synonyms | Arms |
---|
Tislelizumab | BGB-A317 | Arm A: Tislelizumab plus Ociperlimab |
Ociperlimab | BGB-A1217 | Arm A: Tislelizumab plus Ociperlimab |
Pembrolizumab | KEYTRUDA | Arm B: Pembrolizumab plus Placebo |
Placebo | | Arm B: Pembrolizumab plus Placebo |
Purpose
The purpose of the study is to compare progression-free survival (PFS) between Arm A
(ociperlimab in combination with tislelizumab) and Arm B (pembrolizumab in combination with
placebo) as assessed by investigators according to Response Evaluation Criteria in Solid
Tumors Version 1.1 (RECIST v1.1) and to compare overall survival (OS) between Arm A and Arm
B.
Trial Arms
Name | Type | Description | Interventions |
---|
Arm A: Tislelizumab plus Ociperlimab | Experimental | Participants will receive tislelizumab 200 milligrams (mg) intravenously followed by ociperlimab 900 mg intravenously once every 3 weeks. | |
Arm B: Pembrolizumab plus Placebo | Active Comparator | Participants will receive pembrolizumab 200 mg intravenously followed by placebo intravenously once every 3 weeks. | |
Arm C: Tislelizumab plus Placebo | Placebo Comparator | Participants will receive tislelizumab 200 mg intravenously followed by placebo intravenously once every 3 weeks. | |
Eligibility Criteria
Key Inclusion Criteria:
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 (formalin-fixed paraffin-embedded block
containing tumor [preferred] or 6 to 15 freshly cut unstained slides) or fresh biopsy
(if archival tissue is not available) for prospective central evaluation of programmed
cell death ligand-1 (PD-L1) levels and retrospective analysis of other biomarkers.
4. Tumors with PD-L1 tumor cell ≥ 50% expression as centrally determined.
5. At least 1 measurable lesion as defined per RECIST v1.1.
Key Exclusion Criteria:
1. Known sensitizing mutation in the epidermal growth factor receptor (EGFR) gene or an
anaplastic lymphoma kinase fusion oncogene.
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.
5. Any active malignancy ≤ 2 years before randomization except for the specific cancer
under investigation in this study and any locally recurring cancer that has been
treated curatively (for example, resected basal or squamous cell skin cancer,
superficial bladder cancer, carcinoma in situ of the cervix or breast).
Note: Other protocol defined 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) As Assessed By Investigators |
Time Frame: | Up to approximately 39 months |
Safety Issue: | |
Description: | 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. |
Secondary Outcome Measures
Measure: | PFS As Assessed By A Blinded Independent Review Committee |
Time Frame: | Up to approximately 39 months |
Safety Issue: | |
Description: | 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. |
Measure: | Overall Response Rate (ORR) As Assessed By Investigators |
Time Frame: | Up to approximately 39 months |
Safety Issue: | |
Description: | ORR will be defined as the proportion of participants with a documented, confirmed complete response or partial response per RECIST v1.1. |
Measure: | Duration Of Response (DOR) As Assessed By Investigators |
Time Frame: | Up to approximately 39 months |
Safety Issue: | |
Description: | 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. |
Measure: | Health-related Quality Of Life (HRQoL): European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire Core 30 (EORTC QLQ-C30) |
Time Frame: | Within 7 days after last dose |
Safety Issue: | |
Description: | HRQoL will be assessed via patient-reported outcomes (PRO) using the EORTC QLQ-C30.
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: | HRQoL: EORTC Lung Cancer Module Quality Of Life Questionnaire Lung Cancer 13 (QLQ-LC13) |
Time Frame: | Within 7 days after last dose |
Safety Issue: | |
Description: | HRQoL will be assessed via PRO using the EORTC QLQ-LC13. 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: | HRQoL: The 5 Level EuroQol 5 Dimension (EQ-5D-5L) Questionnaire |
Time Frame: | Within 7 days after last dose |
Safety Issue: | |
Description: | HRQoL will be assessed via PRO using the EQ-5D-5L. 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: | Time To Deterioration (TDD) |
Time Frame: | Within 7 days after last dose |
Safety Issue: | |
Description: | TDD will be analyzed using the global health status of QLQ-C30 and will be defined as worsening scores for 2 consecutive assessments or 1 assessment followed by death from any cause. |
Measure: | Number Of Participants Experiencing Adverse Events (AEs) |
Time Frame: | 90 days (±14) after last dose |
Safety Issue: | |
Description: | 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). |
Details
Phase: | Phase 3 |
Primary Purpose: | Interventional |
Overall Status: | Recruiting |
Lead Sponsor: | BeiGene |
Trial Keywords
- Locally Advanced
- Unresectable
- Metastatic
- Tislelizumab
- BGB-A317
- Ociperlimab
- BGB-A1217
- Pembrolizumab
- Anti-TIGIT
Last Updated
June 14, 2021