Ociperlimab With Tislelizumab and Chemotherapy in Patients With Untreated Metastatic Non-Small Cell Lung Cancer

Study Overview
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Brief Summary
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This is a randomized investigator and patient blinded, sponsor unblinded, multicenter study that evaluates the safety and efficacy of ociperlimab with tislelizumab and histology-based chemotherapy compared with treatment with tislelizumab and histology-based chemotherapy in participants with previously untreated locally advanced, unresectable, or metastatic NSCLC

Official Title
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AdvanTIG-205: A Phase 2, Randomized Study of Ociperlimab (BGB-A1217) and Tislelizumab With Chemotherapy in Patients With Previously Untreated Locally Advanced, Unresectable, or Metastatic Non-Small Cell Lung Cancer (NSCLC)

Conditions
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Locally Advanced, Unresectable, or Metastatic Nonsmall Cell Lung Cancer (NSCLC), Nonsmall Cell Lung Cancer, Stage IV

Intervention / Treatment
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* Drug: Ociperlimab
* Drug: Tislelizumab
* Drug: histology-based chemotherapy
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Key Inclusion Criteria: Histologically or cytologically documented locally advanced or recurrent NSCLC that is not eligible for curative surgery and/or definitive radiotherapy, with or without chemotherapy, or metastatic non-squamous or squamous NSCLC. No prior systemic therapy for locally advanced or metastatic squamous or non-squamous NSCLC, including but not limited to chemotherapy or targeted therapy. Patients who have received prior neoadjuvant, adjuvant chemotherapy, or chemoradiotherapy with curative intent for nonmetastatic disease must have experienced a disease-free interval of ≥ 6 months from the last dose of chemotherapy and/or concurrent radiotherapy prior to randomization. Archival tumor tissue or fresh biopsy (if archival tissue is not available) for the determination of PD-L1 levels and retrospective analyses of other biomarkers. Only patients who have evaluable PD-L1 results are eligible. At least one measurable lesion by the investigator per RECIST v1.1. . Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 1. Key Exclusion Criteria: Known mutations in: EGFR gene Note: For non-squamous NSCLC, patients with unknown EGFR mutation status will be required to have a tissue-based EGFR test either locally or at the central laboratory before enrollment, or endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA)-based EGFR test locally. Patients found to have EGFR-sensitizing mutations will be excluded. ALK fusion oncogene. BRAF V600E ROS1 Prior treatment with EGFR inhibitors, ALK inhibitors, or targeted therapy for other driver mutations. Any prior therapy targeting T-cell costimulation or checkpoint pathways in metastatic NSCLC. Any condition that required systemic treatment with either corticosteroids (> 10 mg daily of prednisone or equivalent) or other immunosuppressive medication ≤ 14 days before randomization. Infection (including tuberculosis infection, etc.) requiring systemic antibacterial, antifungal, or antiviral therapy within 14 days before randomization. Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm A: Ociperlimab + tislelizumab histology-based chemotherapy<br> | Drug: Ociperlimab<br>* Ociperlimab intravenous injection<br>* Other names: BGB-A1217;Drug: Tislelizumab<br>* Tislelizumab intravenous injection<br>* Other names: BGB-A317;Drug: histology-based chemotherapy<br>* Administered intravenously<br>|
| Placebo Comparator: Arm B: Placebo + tislelizumab + histology-based chemotherapy<br> | Drug: Tislelizumab<br>* Tislelizumab intravenous injection<br>* Other names: BGB-A317;Drug: histology-based chemotherapy<br>* Administered intravenously<br>Drug: Placebo<br>* Administered as an intravenous injection<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free Survival (PFS) as Assessed by Investigators | 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 | Up to approximately 30 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Response Rate (ORR) as Assessed by Investigators | ORR will be defined as the proportion of participants with a documented, confirmed complete response or partial response per RECIST v1.1. | Up to approximately 30 months | 
| Duration of Response (DoR) As Assessed by Investigators | DOR is defined as the time from the date that response criteria are first met to the date that progressive disease is objectively documented or death, whichever comes first | Up to approximately 30 months | 
| Overall Survival (OS) | OS will be defined as the time from the date of randomization to the date of death due to any cause. | Up to approximately 30 months | 
| Number of Participants Experiencing Adverse Events (AEs) | 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). | 90 days (±14) after last dose | 
| Serum concentrations of ociperlimab and tislelizumab at prespecified timepoints |  | Up to approximately 12 months or end of treatment visit | 
| Immunogenic responses to ociperlimab and tislelizumab, evaluated through detection of anti-drug antibodies (ADAs). |  | Up to approximately 12 months or end of treatment visit | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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metastatic, Lung Cancer, Non-Squamous, Ociperlimab, Tislelizumab, Anti-PD-1, BGB-A317, BGB-A1217, Anti-TIGIT