A Phase 3, Open-Label, Multicenter, 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 Patients With Stage IIIB or IV Non-Squamous Non-Small Cell Lung Cancer
Overview
- Phase
- Phase 3
- Intervention
- Tislelizumab
- Conditions
- Non-Small Cell Lung Cancer
- Sponsor
- BeiGene
- Enrollment
- 334
- Locations
- 47
- Primary Endpoint
- Progression Free Survival (PFS) Assessed by Independent Review Committee (IRC) Assessment
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
This study evaluated the efficacy and safety of tislelizumab in combination with platinum (cisplatin or carboplatin) and pemetrexed compared with platinum and pemetrexed alone as first-line treatment in participants with Stage IIIB or IV non-squamous non-small cell lung cancer (NSCLC).
Investigators
Eligibility Criteria
Inclusion Criteria
- •Age 18-75 years old, male or female, signed informed consent form
- •Advanced NSCLC diagnosed by pathological or clinical physicians
- •Eastern Cooperative Oncology Group (ECOG) performance score ≤ 1
- •Participants must have ≥ 1 measurable lesion as defined per RECIST v1.1
- •Participants must have no prior systemic chemotherapy for advanced or metastatic 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 epidermal growth factor receptor (EGFR)-sensitizing mutation or anaplastic lymphoma kinase (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 programmed cell death protein-1 (PD-1) or programmed cell death protein ligand-1 (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
- •Human immunodeficiency virus (HIV) infection
- •Participants with untreated hepatitis B or C virus (HBV/HCV)
Arms & Interventions
Tislelizumab + Platinum + Pemetrexed
Tislelizumab 200 milligrams (mg) administered intravenously (IV) once every 3 weeks plus cisplatin 75 mg/m\^2 or carboplatin area under the plasma or serum concentration-time curve (AUC) 5 once every 3 weeks for 4 to 6 cycles and pemetrexed 500 mg/m\^2 once every 3 weeks until unacceptable toxicity or disease progression (each cycle is 21 days)
Intervention: Tislelizumab
Tislelizumab + Platinum + Pemetrexed
Tislelizumab 200 milligrams (mg) administered intravenously (IV) once every 3 weeks plus cisplatin 75 mg/m\^2 or carboplatin area under the plasma or serum concentration-time curve (AUC) 5 once every 3 weeks for 4 to 6 cycles and pemetrexed 500 mg/m\^2 once every 3 weeks until unacceptable toxicity or disease progression (each cycle is 21 days)
Intervention: Cisplatin
Tislelizumab + Platinum + Pemetrexed
Tislelizumab 200 milligrams (mg) administered intravenously (IV) once every 3 weeks plus cisplatin 75 mg/m\^2 or carboplatin area under the plasma or serum concentration-time curve (AUC) 5 once every 3 weeks for 4 to 6 cycles and pemetrexed 500 mg/m\^2 once every 3 weeks until unacceptable toxicity or disease progression (each cycle is 21 days)
Intervention: Carboplatin
Tislelizumab + Platinum + Pemetrexed
Tislelizumab 200 milligrams (mg) administered intravenously (IV) once every 3 weeks plus cisplatin 75 mg/m\^2 or carboplatin area under the plasma or serum concentration-time curve (AUC) 5 once every 3 weeks for 4 to 6 cycles and pemetrexed 500 mg/m\^2 once every 3 weeks until unacceptable toxicity or disease progression (each cycle is 21 days)
Intervention: Pemetrexed
Platinum + Pemetrexed
Cisplatin 75 mg/m\^2 or carboplatin AUC 5 once every 3 weeks for 4 to 6 cycles and pemetrexed 500 mg/m\^2 administered IV once every 3 weeks until unacceptable toxicity or disease progression (each cycle is 21 days)
Intervention: Cisplatin
Platinum + Pemetrexed
Cisplatin 75 mg/m\^2 or carboplatin AUC 5 once every 3 weeks for 4 to 6 cycles and pemetrexed 500 mg/m\^2 administered IV once every 3 weeks until unacceptable toxicity or disease progression (each cycle is 21 days)
Intervention: Carboplatin
Platinum + Pemetrexed
Cisplatin 75 mg/m\^2 or carboplatin AUC 5 once every 3 weeks for 4 to 6 cycles and pemetrexed 500 mg/m\^2 administered IV once every 3 weeks until unacceptable toxicity or disease progression (each cycle is 21 days)
Intervention: Pemetrexed
Outcomes
Primary Outcomes
Progression Free Survival (PFS) Assessed by Independent Review Committee (IRC) Assessment
Time Frame: Through primary analysis data cut-off date of 23JAN2020 (up to approximately 1 year and 6 months)
PFS is defined as the time from randomization until first documentation of progression or death from any cause, whichever occurs first, as assessed by the IRC per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Secondary Outcomes
- Objective Response Rate (ORR) by IRC Assessment(Through study completion data cut-off date of 26APR2023 (up to approximately 4 years and 9 months))
- Duration of Response (DOR) by IRC Assessment(Through study completion data cut-off date of 26APR2023 (up to approximately 4 years and 9 months))
- Overall Survival (OS)(Through study completion data cut-off date of 26APR2023 (up to approximately 4 years and 9 months))
- PFS by Investigator Assessment(Through study completion data cut-off date of 26APR2023 (up to approximately 4 years and 9 months))
- ORR by Investigator Assessment(Through study completion data cut-off date of 26APR2023 (up to approximately 4 years and 9 months))
- DOR by Investigator Assessment(Through study completion data cut-off date of 26APR2023 (up to approximately 4 years and 9 months))
- Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Lung Cancer (EORTC QLQ-LC13)(Baseline to Cycle 5 (each cycle is 21 days))
- Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Global Health Status(Baseline to Cycle 5 (each cycle is 21 days))
- Number of Participants With Adverse Events(Through study completion data cut-off date of 26APR2023 (up to approximately 4 years and 9 months))
- PFS by IRC Based on Programmed Death Ligand 1 (PD-L1) Expression(Through study completion data cut-off date of 26APR2023 (up to approximately 4 years and 9 months))