A Study Evaluating the Efficacy and Safety of Tislelizumab Versus Chemotherapy in Advanced Non-Squamous NSCLC

Study Overview
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Brief Summary
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A Phase 3, Open-Label, Multi-Center, Randomized Study to Investigate the Efficacy and Safety of Tislelizumab (BGB-A317) (Anti-PD1 Antibody) Combined With Platinum-Pemetrexed Versus Platinum-Pemetrexed Alone as First-line Treatment for Participants With Stage IIIB or IV Non-Squamous Non-Small Cell Lung Cancer. 45 sites will be involved in China, 320 subjects will be enrolled.

Official Title
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Phase III Open Label First Line Therapy Study of Tislelizumab With Chemotherapy Versus Chemotherapy in Untreated Advanced Non-Squamous Non-Small Cell Lung Cancer(NSCLC)

Conditions
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Non-Small Cell Lung Cancer

Intervention / Treatment
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* Drug: Tislelizumab,Cisplatin or Carboplatin ,Pemetrexed
* Drug: Cisplatin or Carboplatin,Pemetrexed


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18-75 years old, male or female, signed ICF Advanced NSCLC diagnosed by pathological or clinical physicians ECOG PS ≤ 1 Participants must have ≥ 1 measurable lesion as defined per RECIST v1.1 Participants must have no prior systemic chemotherapy for advanced or metastatic non-squamous NSCLC Life expectancy ≥ 12 weeks Participants must have adequate organ function Male/Female is willing to use a highly effective method of birth control Exclusion Criteria: Diagnosed with NSCLC but with EGFR-sensitizing mutation or ALK gene translocation Received any approved systemic anticancer therapy within 28 days prior to the initiation of study treatment Received prior treatment with EGFR inhibitors or ALK inhibitors Received prior therapies targeting PD-1 or PD-L1 With history of interstitial lung disease, non-infectious pneumonitis or uncontrolled systemic diseases Clinically significant pericardial effusion Severe infections, Active leptomeningeal disease or uncontrolled, untreated brain metastasis Any major surgical procedure ≤ 28 days before randomization HIV infection Participants with untreated HBV/HCV Active autoimmune diseases or history of autoimmune diseases History of allergic reactions to chemotherapy NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 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: Tislelizumab combined with Platinum and Pemetrexed<br>Tislelizumab will be administered at a dose of 200 mg intravenously (IV) Q3W. Cisplatin 75 mg/m2 administered as an intravenous (IV) infusion over 2 hours Q3W (every 3 weeks) for 4 to 6 cycles or Carboplatin AUC 5 administered as an IV infusion over 15 minutes Q3W for 4 to 6 cycles. Pemetrexed 500 mg/m2 administered as an IV infusion over 10 minutes Q3W. | Drug: Tislelizumab,Cisplatin or Carboplatin ,Pemetrexed<br>* Treatment for advanced NSCLC<br>|
| Active Comparator: Cisplatin or Carboplatin and Pemetrexed<br> | Drug: Cisplatin or Carboplatin,Pemetrexed<br>* Treatment for advanced NSCLC<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression Free Survival (PFS) assessed by Independent Review Committee(IRC) |  | approximately 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective Response Rate (ORR) assessed by Independent Review Committee(IRC) |  | approximately 2 years | 
| Duration Of Response (DOR) assessed by Independent Review Committee(IRC) |  | approximately 2 years | 
| Overall Survival |  | approximately 3 years | 
| Progression Free Survival (PFS) as assessed by the investigator |  | approximately 2 years | 
| Objective response rate (ORR) as assessed by the investigator |  | approximately 2 years | 
| Duration of response (DOR) as assessed by the investigator |  | approximately 2 years | 
| health-related quality of life (HRQoL)- measured using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Lung Cancer (EORTC QLQ LC13) as presented in participants-reported outcomes | Scale construct including to assess dyspnoea, and a series of single items assessing pain, coughing, sore mouth, dysphagia, peripheral neuropathy, alopecia, and haemoptysis; each item with range of maximum scores 4 as worse outcome and minimum scores 1 as higher values represent a better | approximately 2 years | 
| health-related quality of life (HRQoL)- measured using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Lung Cancer Core 30 (EORTC QLQ-C30) as presented in participants-reported outcomes | Scale construct including to assess Global health status/QoL with range from minimum scores 1 as worse outcome and maximum scores 7 as higher values represent a better; Physical functioning, Role functioning, Emotional functioning, Cognitive functioning, Social functioning, Fatigue, Nausea and vomiting, Pain Dyspnoea, Insomnia, Appetite loss, Constipation, Diarrhoea and Financial difficulties with range from maximum scores 4 as worse outcome and from minimum scores 1 as higher values represent a better. | approximately 2 years | 
| Incidence and severity of treatment-emergent AEs (TEAEs) graded according to National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE), v4.03 |  | approximately 2 years | 
| PD-L1 expression by IHC |  | approximately 2 years |