A Study of Tislelizumab in Combination With Chemotherapy Versus Chemotherapy in Advanced Lung Cancer
- Conditions
- Non-Small Cell Lung Cancer
- Interventions
- Registration Number
- NCT03594747
- Lead Sponsor
- BeiGene
- Brief Summary
An open-label, randomized, multicenter Phase 3 study designed to compare the efficacy and safety of tislelizumab combined with chemotherapy versus chemotherapy only as first-line treatment in advanced squamous non-small cell lung cancer (NSCLC).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 360
- Age 18-75 years old, male or female, and signed informed consent form (ICF)
- Advanced NSCLC diagnosed by pathological or clinical physicians
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤ 1
- Participants must have ≥ 1 measurable lesion as defined per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
- Must be treatment-naive for locally advanced or metastatic 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
Key
- Diagnosed with NSCLC but with epidermal growth factor receptors (EGFR)-sensitizing mutation or anaplastic lymphoma kinase (ALK) gene translocation
- Received any approved systemic anticancer therapy
- Received prior treatment with EGFR inhibitors or ALK inhibitors
- Received prior therapies targeting programmed death 1 (PD-1) or programmed death ligand 1 (PD-L1)
- With history of interstitial lung disease
- Clinically significant pericardial effusion
- Severe infections, active leptomeningeal disease or uncontrolled, untreated brain metastasis
- Any major surgical procedure before randomization
- Human immunodeficiency virus infection
- Untreated hepatitis B virus (HBV)/hepatitis C virus (HCV)
- Active autoimmune diseases or history of autoimmune diseases
- History of allergic reactions to chemotherapy
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Paclitaxel + Carboplatin Paclitaxel Paclitaxel 175 mg/m\^2 and carboplatin AUC 5 on Day 1 administered intravenously once every 3 weeks for 4 to 6 cycles (each cycle is 21 days) Tislelizumab + Nab-paclitaxel + Carboplatin Nab-paclitaxel Tislelizumab 200 mg on Day 1 plus Nab-paclitaxel 100 mg/m\^2 on Days 1, 8, and 15 and carboplatin AUC 5 on Day 1 administered intravenously once every 3 weeks until unacceptable toxicity, withdrawal of consent, loss of clinical benefit, or disease progression; Nab-paclitaxel and carboplatin were administered for 4 to 6 cycles (each cycle is 21 days) Tislelizumab + Paclitaxel + Carboplatin Tislelizumab Tislelizumab 200 milligrams (mg) plus paclitaxel 175 mg/m\^2 and carboplatin area under the plasma or serum concentration-time curve (AUC) 5 on Day 1 administered intravenously once every 3 weeks until unacceptable toxicity, withdrawal of consent, loss of clinical benefit, or disease progression; paclitaxel and carboplatin were administered for 4 to 6 cycles (each cycle is 21 days) Tislelizumab + Paclitaxel + Carboplatin Paclitaxel Tislelizumab 200 milligrams (mg) plus paclitaxel 175 mg/m\^2 and carboplatin area under the plasma or serum concentration-time curve (AUC) 5 on Day 1 administered intravenously once every 3 weeks until unacceptable toxicity, withdrawal of consent, loss of clinical benefit, or disease progression; paclitaxel and carboplatin were administered for 4 to 6 cycles (each cycle is 21 days) Tislelizumab + Paclitaxel + Carboplatin Carboplatin Tislelizumab 200 milligrams (mg) plus paclitaxel 175 mg/m\^2 and carboplatin area under the plasma or serum concentration-time curve (AUC) 5 on Day 1 administered intravenously once every 3 weeks until unacceptable toxicity, withdrawal of consent, loss of clinical benefit, or disease progression; paclitaxel and carboplatin were administered for 4 to 6 cycles (each cycle is 21 days) Tislelizumab + Nab-paclitaxel + Carboplatin Tislelizumab Tislelizumab 200 mg on Day 1 plus Nab-paclitaxel 100 mg/m\^2 on Days 1, 8, and 15 and carboplatin AUC 5 on Day 1 administered intravenously once every 3 weeks until unacceptable toxicity, withdrawal of consent, loss of clinical benefit, or disease progression; Nab-paclitaxel and carboplatin were administered for 4 to 6 cycles (each cycle is 21 days) Tislelizumab + Nab-paclitaxel + Carboplatin Carboplatin Tislelizumab 200 mg on Day 1 plus Nab-paclitaxel 100 mg/m\^2 on Days 1, 8, and 15 and carboplatin AUC 5 on Day 1 administered intravenously once every 3 weeks until unacceptable toxicity, withdrawal of consent, loss of clinical benefit, or disease progression; Nab-paclitaxel and carboplatin were administered for 4 to 6 cycles (each cycle is 21 days) Paclitaxel + Carboplatin Carboplatin Paclitaxel 175 mg/m\^2 and carboplatin AUC 5 on Day 1 administered intravenously once every 3 weeks for 4 to 6 cycles (each cycle is 21 days)
- Primary Outcome Measures
Name Time Method Progression Free Survival (PFS) by Independent Review Committee (IRC) Assessment as of Data Cut-off Date of 06DEC2019 Through primary analysis data cut-off date of 06DEC2019 (up to approximately 1 year and 4 months) PFS is defined as the time from randomization until first documentation of disease progression as assessed by the IRC per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 or death from any cause, whichever occurs first
PFS by IRC Assessment as of Data Cut-off Date of 30SEP2020 Through primary analysis data cut-off date of 30SEP2020 (up to approximately 2 years and 2 months) PFS is defined as the time from randomization until first documentation of disease progression as assessed by the IRC per RECIST v1.1 or death from any cause, whichever occurs first
- Secondary Outcome Measures
Name Time Method Overall Survival (OS) Through study completion data cut-off date of 28APR2023 (up to approximately 4 years and 9 months) OS is defined as the time from randomization until the date of death due to any cause
Objective Response Rate (ORR) by IRC Assessment Through study completion data cut-off date of 28APR2023 (up to approximately 4 years and 9 months) ORR is defined as the percentage of participants with complete response (CR) and partial response (PR), as assessed by the IRC using RECIST v1.1.
ORR by Investigator Assessment Through study completion data cut-off date of 28APR2023 (up to approximately 4 years and 9 months) ORR is defined as the percentage of participants with complete response (CR) and partial response (PR), as assessed by the investigator using RECIST v1.1.
Duration of Response (DOR) by IRC Assessment Through study completion data cut-off date of 28APR2023 (up to approximately 4 years and 9 months) DOR is defined as the time from the first occurrence of a documented objective response to the time of documented disease progression assessed by the IRC using RECIST v1.1, or death from any cause, whichever comes first, in all randomized participants with documented objective responses. Data are based on number of responders.
DOR by Investigator Assessment Through study completion data cut-off date of 28APR2023 (up to approximately 4 years and 9 months) DOR is defined as the time from the first occurrence of a documented objective response to the time of documented disease progression assessed by the investigator using RECIST v1.1, or death from any cause, whichever comes first, in all randomized participants with documented objective responses. Data are based on number of responders.
PFS by Investigator Assessment Through study completion data cut-off date of 28APR2023 (up to approximately 4 years and 9 months) PFS is defined as the time from randomization until first documentation of disease progression as assessed by the investigator per RECIST v1.1 or death from any cause, whichever occurs first
PFS by IRC Based on Programmed Death Ligand 1 (PD-L1) Expression Through study completion data cut-off date of 28APR2023 (up to approximately 4 years and 9 months) PFS is defined as the time from randomization until first documentation of disease progression as assessed by the IRC per RECIST v1.1 or death from any cause, whichever occurs first, based on PD-L1 expression in tumor cells
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 Least squares mean change from baseline in EORTC QLQ-CL13 scores for chest pain, coughing, and dyspnea between tislelizumab arms and paclitaxel + carboplatin arm. The EORTC QLQ-LC13 is a questionnaire that measures lung cancer-specific disease and treatment symptoms. It includes questions about specific symptoms in which participants respond based on a 4-point scale, where 1 is "not at all" and 4 is "very much". Raw scores are transformed into a 0 to 100 scale via linear transformation. A lower score indicates an improvement in symptoms.
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 Least squares mean change from baseline in EORTC QLQ-C30 Global Health Status/Quality of Life score between tislelizumab arms and paclitaxel + carboplatin arm. The EORTC QLQ-C30 v3.0 is a questionnaire that assesses quality of life of cancer patients. It includes global health status and quality of life questions related to overall health in which participants respond based on a 7-point scale, where 1 is very poor and 7 is excellent. Raw scores are transformed into a 0 to 100 scale via linear transformation. A higher score indicates better health outcomes.
Number of Participants With Adverse Events From first dose to 30 days after the last dose (up to approximately 4 years and 9 months) Number of participants with treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs), which includes laboratory tests, physical exams, electrocardiogram results and vital signs, according to National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) v5.0
Trial Locations
- Locations (51)
Anhui Provincial Hospital
🇨🇳Hefei, Anhui, China
The First Affiliated Hospital of Anhui Medical University
🇨🇳Hefei, Anhui, China
Cancer Hospital Chinese Academy of Medical Sciences
🇨🇳Beijing, Beijing, China
Beijing Cancer Hospital
🇨🇳Beijing, Beijing, China
Beijing Hospital
🇨🇳Beijing, Beijing, China
Peking Union Medical College Hospital
🇨🇳Beijing, Beijing, China
Chinese PLA General Hospital
🇨🇳Beijing, Beijing, China
Beijing Chest Hospital,Capital Medical University
🇨🇳Beijing, Beijing, China
The Second Affiliated Hospital of Chongqing Medical University
🇨🇳Chongqing, Chongqing, China
The First Hospital Affiliated to AMU (Southwest Hospital)
🇨🇳Chongqing, Chongqing, China
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