Comparison of Efficacy and Safety of Anti-PD-1 Antibody BGB-A317 Versus Docetaxel as Treatment in the Second- or Third-line Setting in Participants With NSCLC

Study Overview
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Brief Summary
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The purpose of this study is to show that BGB-A317 will improve overall survival in participants with Stage IIIB or IV non-small cell lung cancer when compared to docetaxel in second or third-line treatment setting.

Detailed Description
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This is a randomized, open-label, multicenter Phase 3 study in adult participants with histologically confirmed, locally advanced or metastatic (Stage IIIB or IV), NSCLC (squamous or non-squamous) who have disease progression during or after a platinum-containing regimen.

Official Title
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A Phase 3, Open-Label, Multicenter, Randomized Study to Investigate the Efficacy and Safety of BGB-A317 (Anti-PD1 Antibody) Compared With Docetaxel in Patients With Non-Small Cell Lung Cancer Who Have Progressed on a Prior Platinum-Containing Regimen

Conditions
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Non-small Cell Lung Cancer

Intervention / Treatment
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* Drug: Tislelizumab
* Drug: Docetaxel


Participation Criteria
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Eligibility Criteria
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Key Inclusion Criteria: Age18 years. Signed Informed Consent Form. Histologically confirmed locally advanced or metastatic (Stage IIIB or IV) NSCLC of either squamous or non-squamous histology types with disease progression during or following treatment with at least one platinum-containing regimen, but no more than 2 lines of systemic therapy. Participants must be able to provide fresh or archival tumor tissues for central assessment of PD-L1 expression in tumor cells. Participants with non-squamous histology must provide evidence of not harboring sensitizing EGFR mutation tested by a histology-based method. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1. Adequate hematologic and end-organ function. Expected life span > 12 weeks. Willing to be compliance with birth control requirement during pre-specified study participating period Key Exclusion Criteria: Prior therapies of docetaxel or treatment targeting PD-1, PD-L1 or CTLA-4. Harboring EGFR sensitizing mutation or ALK gene translocation. Unresolved side effects of Grade 2 and above from prior anti-cancer therapies, except for AEs not constituting a likely safety risk (e.g. alopecia, rash, pigmentation, specific lab abnormalities). History of severe hypersensitivity reactions to other mAbs. History of interstitial lung disease, non-infectious pneumonitis or participants with significantly impaired pulmonary function, or who require supplemental oxygen at baseline. With uncontrollable pleural effusion, pericardial effusion, or clinically significant ascites requiring interventional treatment. Active Leptomeningeal disease or uncontrolled, untreated brain metastasis. Severe chronic or active infection requiring systemic treatment. Known HIV infection, participants with untreated chronic hepatitis B, active vaccination treatment. Insufficient cardiac functions and other underlying unfavorable cardiovascular conditions. Prior allogeneic stem cell transplantation or organ transplantation. Active autoimmune diseases or history of autoimmune diseases that may relapse. With conditions requiring systemic treatment with either corticosteroids (>10 mg daily prednisone or equivalent) or other immunosuppressive medications. With severe underlying medical conditions (including laboratory abnormalities) or alcohol or drug abuse that may affect the explanation of drug toxicity or AEs or result in impaired compliance with study conduct. 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BGB-A317<br>100 mg per vial, 200mg intravenous (IV), Q3W | Drug: Tislelizumab<br>* Intravenous injection (Anti-PD-1 monoclonal antibody)<br>* Other names: BGB-A317;|
| Experimental: Docetaxel<br>75 mg/m2 IV Q3W | Drug: Docetaxel<br>* Intravenous injection (Antineoplastic, cytotoxic, taxane)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival (OS) in PD-L1+ and all participants (co-primary endpoint) |  | Up to 31 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective response rate(ORR) |  | Up to 31 months | 
| Duration of response (DOR) |  | Up to 31 months | 
| Progression-free survival (PFS) |  | Up to 31 months | 
| Health-related Quality of Life (HRQoL) |  | Up to 31 months | 
| Incidence and severity of treatment-emergent adverse events (TEAEs) graded according to NCI-CTCAE, v4.03. |  | Up to 31 months |