Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| CTR20180032 | Registry Identifier | ChinaDrugTrials |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tislelizumab + Platinum + Pemetrexed | Experimental | 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) |
|
| Platinum + Pemetrexed | Active Comparator | 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) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tislelizumab | Drug | Administered intravenously |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression Free Survival (PFS) Assessed by Independent Review Committee (IRC) Assessment | 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 | Through primary analysis data cut-off date of 23JAN2020 (up to approximately 1 year and 6 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) by IRC Assessment | ORR is defined as the percentage of participants with complete response (CR) or partial response (PR), as assessed by the IRC using RECIST v1.1. | Through study completion data cut-off date of 26APR2023 (up to approximately 4 years and 9 months) |
| Duration of Response (DOR) by IRC Assessment |
Not provided
Inclusion Criteria:
Exclusion Criteria:
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Not provided
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| Name | Affiliation | Role |
|---|---|---|
| Study Director | BeiGene | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Anhui Provincial Hospital | Hefei | Anhui | 230000 | China | ||
| Cancer Hospital Chinese Academy of Medical Sciences |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34033975 | Result | Lu S, Wang J, Yu Y, Yu X, Hu Y, Ai X, Ma Z, Li X, Zhuang W, Liu Y, Li W, Cui J, Wang D, Liao W, Zhou J, Wang Z, Sun Y, Qiu X, Gao J, Bao Y, Liang L, Wang M. Tislelizumab Plus Chemotherapy as First-Line Treatment for Locally Advanced or Metastatic Nonsquamous NSCLC (RATIONALE 304): A Randomized Phase 3 Trial. J Thorac Oncol. 2021 Sep;16(9):1512-1522. doi: 10.1016/j.jtho.2021.05.005. Epub 2021 May 23. | |
| 40946254 |
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This study was conducted at 47 study centers in China.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jan 24, 2019 | Apr 11, 2024 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Cisplatin | Drug | Administered intravenously |
|
| Carboplatin | Drug | Administered intravenously |
|
| Pemetrexed | Drug | Administered intravenously |
|
DOR is defined as the time from the first occurrence of a documented objective response to the time of documented disease progression, or death from any cause, whichever comes first, as assessed by the IRC using RECIST v1.1 in participants with documented objective responses |
| Through study completion data cut-off date of 26APR2023 (up to approximately 4 years and 9 months) |
| Overall Survival (OS) | OS is defined as the time from randomization until the date of death due to any cause | Through study completion data cut-off date of 26APR2023 (up to approximately 4 years and 9 months) |
| PFS by Investigator Assessment | PFS is defined as the time from randomization until first objectively documented disease progression, or death from any cause, whichever occurs first, as assessed by the investigator per RECIST v1.1 | Through study completion data cut-off date of 26APR2023 (up to approximately 4 years and 9 months) |
| ORR by Investigator Assessment | ORR is defined as the percentage of participants with CR or PR, as assessed by the investigator using RECIST v1.1 | Through study completion data cut-off date of 26APR2023 (up to approximately 4 years and 9 months) |
| DOR by Investigator Assessment | DOR is defined as the time from the first occurrence of a documented objective response to the time of documented disease progression, or death from any cause, whichever comes first, as assessed by the investigator using RECIST v1.1 in participants with documented objective responses | 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) | Change from baseline in EORTC QLQ-CL13 scores for coughing, dyspnea, and chest pain . 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. | 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 | Change from baseline in EORTC QLQ-C30 Global Health Status/Quality of Life score. The EORTC QLQ-C30 v3.0 is a questionnaire that assesses quality of life of participants with cancer. 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. | Baseline to Cycle 5 (each cycle is 21 days) |
| Number of Participants With Adverse Events | 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 | 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 | 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 RECIST v1.1, based on PD-L1 expression in tumor cells | Through study completion data cut-off date of 26APR2023 (up to approximately 4 years and 9 months) |
| Beijing |
| Beijing Municipality |
| 100021 |
| China |
| Beijing Cancer Hospital | Beijing | Beijing Municipality | 100142 | China |
| Beijing Hospital | Beijing | Beijing Municipality | 100730 | China |
| Peking Union Medical College Hospital | Beijing | Beijing Municipality | 100730 | China |
| Chinese Pla General Hospital | Beijing | Beijing Municipality | 100853 | China |
| The Second Affiliated Hospital of Chongqing Medical University | Chongqing | Chongqing Municipality | 400010 | China |
| Daping Hospital, Third Military Medical University | Chongqing | Chongqing Municipality | 400042 | China |
| Chongqing Three Gorges Central Hospital | Chongqing | Chongqing Municipality | 404000 | China |
| Fujian Cancer Hospital | Fuzhou | Fujian | 350014 | China |
| The First Affiliated Hospital of Xiamen University | Xiamen | Fujian | 361003 | China |
| Cancer Center of Guangzhou Medical University | Guangzhou | Guangdong | 510030 | China |
| Nanfang Hospital of Southern Medical University | Guangzhou | Guangdong | 510515 | China |
| Cancer Hospital of Shantou University Medical College | Shantou | Guangdong | 515031 | China |
| Affiliated Hospital of Guilin Medical University | Guilin | Guangxi | 541001 | China |
| The Peoples Hospital of Guangxi Zhuang Autonomous Region | Nanning | Guangxi | 530021 | China |
| Guizhou Cancer Hospital | Guiyang | Guizhou | 550000 | China |
| The Affiliated Hospital of Zunyi Medical College | Zunyi | Guizhou | 563000 | China |
| Hainan General Hospital | Haikou | Hainan | 570206 | China |
| Harbin Medical University Cancer Hospital | Harbin | Heilongjiang | 150000 | China |
| Henan Cancer Hospital | Zhengzhou | Henan | 450000 | China |
| The First Affiliated Hospital of Zhengzhou University | Zhengzhou | Henan | 450052 | China |
| Hubei Cancer Hospital | Wuhan | Hubei | 430079 | China |
| Changsha Central Hospital | Changsha | Hunan | 410004 | China |
| Hunan Cancer Hospital | Changsha | Hunan | 410013 | China |
| The First Affiliated Hospital of Soochow University Branch Shizi | Suzhou | Jiangsu | 215006 | China |
| Xuzhou Central Hospital | Xuzhou | Jiangsu | 221000 | China |
| The First Hospital of Jilin University | Changchun | Jilin | 130021 | China |
| The First Hospital of China Medical University | Shenyang | Liaoning | 110001 | China |
| Liaoning Cancer Hospital and Institute | Shenyang | Liaoning | 110042 | China |
| The First Affiliated Hospital of Xian Jiaotong University | Xi'an | Shaanxi | 710061 | China |
| Qilu Hospital of Shandong University | Jinan | Shandong | 250000 | China |
| Jinan Central Hospital | Jinan | Shandong | 250013 | China |
| Jinan Military General Hospital | Jinan | Shandong | 250031 | China |
| Shandong Cancer Hospital | Jinan | Shandong | 250117 | China |
| Weifang Peoples Hospital | Weifang | Shandong | 261000 | China |
| Fudan University Shanghai Cancer Center | Shanghai | Shanghai Municipality | 200000 | China |
| Shanghai Chest Hospital | Shanghai | Shanghai Municipality | 200030 | China |
| West China Hospital, Sichuan University | Chengdu | Sichuan | 610041 | China |
| Tianjin Medical University General Hospital | Tianjin | Tianjin Municipality | 300052 | China |
| Tianjin Medical University Cancer Institute and Hospital | Tianjin | Tianjin Municipality | 300060 | China |
| Yunnan Cancer Hospital | Kunming | Yunnan | 650100 | China |
| The First Affiliated Hospital, Zhejiang University School of Medicine | Hangzhou | Zhejiang | 310003 | China |
| Hangzhou First Peoples Hospital | Hangzhou | Zhejiang | 310006 | China |
| Zhejiang University College of Medicine Second Affiliated Hospital | Hangzhou | Zhejiang | 310009 | China |
| Sir Run Run Shaw Hospital, Zhejiang University School of Medicine | Hangzhou | Zhejiang | 310016 | China |
| Zhejiang Cancer Hospital | Hangzhou | Zhejiang | 310022 | China |
| Derived |
| Lu S, Wang J, Yu Y, Yu X, Hu Y, Wangjun L, Li X, Liu Y, Li W, Qu X, Bao Y, Wang M. First-Line Tislelizumab Plus Chemotherapy in Advanced Non-Squamous Non-Small Cell Lung Cancer: PD-L1 >/= 50% Subgroup Analysis from the RATIONALE-304 Trial. Oncol Ther. 2025 Dec;13(4):1087-1104. doi: 10.1007/s40487-025-00378-8. Epub 2025 Sep 14. |
| 35333492 | Derived | Lu S, Yu Y, Barnes G, Qiu X, Bao Y, Tang B. Examining the Impact of Tislelizumab Added to Chemotherapy on Health-Related Quality-of-Life Outcomes in Previously Untreated Patients With Nonsquamous Non-Small Cell Lung Cancer. Cancer J. 2022 Mar-Apr 01;28(2):96-104. doi: 10.1097/PPO.0000000000000583. |
| FG001 | 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) |
| Randomized But Not Treated |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Intent-to-treat (ITT) analysis set included all randomized participants
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Tislelizumab + Platinum + Pemetrexed | Tislelizumab 200 mg administered IV once every 3 weeks plus cisplatin 75 mg/m^2 or carboplatin 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) |
| BG001 | 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) |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Full Range | Years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants | No |
| |||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants | No |
| |||||||||||||||
| Smoking Status | Count of Participants | Participants | No |
| |||||||||||||||
| PD-L1 Expression in Tumor Cells | PD-L1 unevaluable refers to the participants without sample collection, not evaluable at baseline, or scored with unqualified sample. | Count of Participants | Participants | No |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Progression Free Survival (PFS) Assessed by Independent Review Committee (IRC) Assessment | 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 | ITT analysis set included all randomized participants | Posted | Median | 95% Confidence Interval | Months | Through primary analysis data cut-off date of 23JAN2020 (up to approximately 1 year and 6 months) |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Objective Response Rate (ORR) by IRC Assessment | ORR is defined as the percentage of participants with complete response (CR) or partial response (PR), as assessed by the IRC using RECIST v1.1. | ITT analysis set included all randomized participants | Posted | Number | 95% Confidence Interval | Percentage of participants | Through study completion data cut-off date of 26APR2023 (up to approximately 4 years and 9 months) |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Duration of Response (DOR) by IRC Assessment | DOR is defined as the time from the first occurrence of a documented objective response to the time of documented disease progression, or death from any cause, whichever comes first, as assessed by the IRC using RECIST v1.1 in participants with documented objective responses | ITT analysis set included all randomized participants | Posted | Median | 95% Confidence Interval | Months | Through study completion data cut-off date of 26APR2023 (up to approximately 4 years and 9 months) |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Overall Survival (OS) | OS is defined as the time from randomization until the date of death due to any cause | ITT analysis set included all randomized participants | Posted | Median | 95% Confidence Interval | Months | Through study completion data cut-off date of 26APR2023 (up to approximately 4 years and 9 months) |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | PFS by Investigator Assessment | PFS is defined as the time from randomization until first objectively documented disease progression, or death from any cause, whichever occurs first, as assessed by the investigator per RECIST v1.1 | ITT analysis set included all randomized participants | Posted | Median | 95% Confidence Interval | Months | Through study completion data cut-off date of 26APR2023 (up to approximately 4 years and 9 months) |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | ORR by Investigator Assessment | ORR is defined as the percentage of participants with CR or PR, as assessed by the investigator using RECIST v1.1 | ITT analysis set included all randomized participants | Posted | Number | 95% Confidence Interval | Percentage of participants | Through study completion data cut-off date of 26APR2023 (up to approximately 4 years and 9 months) |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | DOR by Investigator Assessment | DOR is defined as the time from the first occurrence of a documented objective response to the time of documented disease progression, or death from any cause, whichever comes first, as assessed by the investigator using RECIST v1.1 in participants with documented objective responses | ITT analysis set included all randomized participants | Posted | Median | 95% Confidence Interval | Months | Through study completion data cut-off date of 26APR2023 (up to approximately 4 years and 9 months) |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Lung Cancer (EORTC QLQ-LC13) | Change from baseline in EORTC QLQ-CL13 scores for coughing, dyspnea, and chest pain . 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. | Health-related quality of life (HRQoL) analysis set included all randomized participants who received at least 1 dose of study drug and completed at least 1 HRQoL assessment | Posted | Least Squares Mean | 95% Confidence Interval | Score on a scale | Baseline to Cycle 5 (each cycle is 21 days) |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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 | Change from baseline in EORTC QLQ-C30 Global Health Status/Quality of Life score. The EORTC QLQ-C30 v3.0 is a questionnaire that assesses quality of life of participants with cancer. 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. | HRQoL analysis set included all randomized participants who received at least 1 dose of study drug and completed at least 1 HRQoL assessment | Posted | Least Squares Mean | 95% Confidence Interval | Score on a scale | Baseline to Cycle 5 (each cycle is 21 days) |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Adverse Events | 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 | Safety analysis set included all randomized participants who received at least one dose of study treatment | Posted | Count of Participants | Participants | Through study completion data cut-off date of 26APR2023 (up to approximately 4 years and 9 months) |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | PFS by IRC Based on Programmed Death Ligand 1 (PD-L1) Expression | 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 RECIST v1.1, based on PD-L1 expression in tumor cells | ITT analysis set included all randomized participants; participants evaluable for PD-L expression were included | Posted | Median | 95% Confidence Interval | Months | Through study completion data cut-off date of 26APR2023 (up to approximately 4 years and 9 months) |
|
|
From first dose up to 30 days after the last dose of study drug; through study completion data cut-off date of 26APR2023 (up to approximately 4 years and 9 months)
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Tislelizumab + Platinum + Pemetrexed | Tislelizumab 200 mg administered IV once every 3 weeks plus cisplatin 75 mg/m^2 or carboplatin 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) | 144 | 223 | 99 | 222 | 222 | 222 |
| EG001 | Platinum + Pemetrexed Alone | 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) | 69 | 111 | 25 | 110 | 109 | 110 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Agranulocytosis | Blood and lymphatic system disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Lymphadenitis | Blood and lymphatic system disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Myelosuppression | Blood and lymphatic system disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Pancytopenia | Blood and lymphatic system disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Cardiac failure acute | Cardiac disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Immune-mediated myocarditis | Cardiac disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Myocarditis | Cardiac disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Right ventricular failure | Cardiac disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Thyroid mass | Endocrine disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Cataract | Eye disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Cataract cortical | Eye disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Chronic gastritis | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Gastrointestinal disorder | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Haemorrhoids | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Immune-mediated enterocolitis | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Immune-mediated gastritis | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Death | General disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Malaise | General disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Biliary obstruction | Hepatobiliary disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Cholecystitis acute | Hepatobiliary disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Immune-mediated hepatitis | Hepatobiliary disorders | MedDRA 25.0 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Device related infection | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Klebsiella infection | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Lymph gland infection | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Rash pustular | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Humerus fracture | Injury, poisoning and procedural complications | MedDRA 25.0 | Systematic Assessment |
| |
| Lower limb fracture | Injury, poisoning and procedural complications | MedDRA 25.0 | Systematic Assessment |
| |
| Spinal compression fracture | Injury, poisoning and procedural complications | MedDRA 25.0 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 25.0 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 25.0 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA 25.0 | Systematic Assessment |
| |
| Gamma-glutamyltransferase increased | Investigations | MedDRA 25.0 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA 25.0 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA 25.0 | Systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA 25.0 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Hypochloraemia | Metabolism and nutrition disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Myositis | Musculoskeletal and connective tissue disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Osteonecrosis | Musculoskeletal and connective tissue disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Cancer pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 25.0 | Systematic Assessment |
| |
| Tumour associated fever | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 25.0 | Systematic Assessment |
| |
| Tumour pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 25.0 | Systematic Assessment |
| |
| Carpal tunnel syndrome | Nervous system disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Cerebellar haemorrhage | Nervous system disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Cerebral infarction | Nervous system disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Cerebrovascular disorder | Nervous system disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Guillain-Barre syndrome | Nervous system disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Ischaemic stroke | Nervous system disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Neuralgia | Nervous system disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Spinal cord compression | Nervous system disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Completed suicide | Psychiatric disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Suicide attempt | Psychiatric disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Glomerulonephritis membranous | Renal and urinary disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Tubulointerstitial nephritis | Renal and urinary disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Benign prostatic hyperplasia | Reproductive system and breast disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Asphyxia | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Interstitial lung disease | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Suffocation feeling | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Aortic aneurysm | Vascular disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Embolism | Vascular disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Venous thrombosis limb | Vascular disorders | MedDRA 25.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Lymphopenia | Blood and lymphatic system disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Palpitations | Cardiac disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Sinus tachycardia | Cardiac disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Supraventricular extrasystoles | Cardiac disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Hyperthyroidism | Endocrine disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Hypothyroidism | Endocrine disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Mouth ulceration | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Toothache | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Chest discomfort | General disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Influenza like illness | General disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Malaise | General disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 25.0 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 25.0 | Systematic Assessment |
| |
| Alpha hydroxybutyrate dehydrogenase increased | Investigations | MedDRA 25.0 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 25.0 | Systematic Assessment |
| |
| Bilirubin conjugated increased | Investigations | MedDRA 25.0 | Systematic Assessment |
| |
| Blood albumin decreased | Investigations | MedDRA 25.0 | Systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA 25.0 | Systematic Assessment |
| |
| Blood bilirubin increased | Investigations | MedDRA 25.0 | Systematic Assessment |
| |
| Blood creatine phosphokinase MB increased | Investigations | MedDRA 25.0 | Systematic Assessment |
| |
| Blood creatine phosphokinase increased | Investigations | MedDRA 25.0 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA 25.0 | Systematic Assessment |
| |
| Blood fibrinogen increased | Investigations | MedDRA 25.0 | Systematic Assessment |
| |
| Blood glucose increased | Investigations | MedDRA 25.0 | Systematic Assessment |
| |
| Blood lactate dehydrogenase increased | Investigations | MedDRA 25.0 | Systematic Assessment |
| |
| Blood sodium decreased | Investigations | MedDRA 25.0 | Systematic Assessment |
| |
| Blood thyroid stimulating hormone increased | Investigations | MedDRA 25.0 | Systematic Assessment |
| |
| Blood urea increased | Investigations | MedDRA 25.0 | Systematic Assessment |
| |
| Blood uric acid increased | Investigations | MedDRA 25.0 | Systematic Assessment |
| |
| Electrocardiogram QT prolonged | Investigations | MedDRA 25.0 | Systematic Assessment |
| |
| Fibrin D dimer increased | Investigations | MedDRA 25.0 | Systematic Assessment |
| |
| Gamma-glutamyltransferase increased | Investigations | MedDRA 25.0 | Systematic Assessment |
| |
| Haemoglobin decreased | Investigations | MedDRA 25.0 | Systematic Assessment |
| |
| Lymphocyte count decreased | Investigations | MedDRA 25.0 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA 25.0 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA 25.0 | Systematic Assessment |
| |
| Protein total decreased | Investigations | MedDRA 25.0 | Systematic Assessment |
| |
| Red blood cell count decreased | Investigations | MedDRA 25.0 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA 25.0 | Systematic Assessment |
| |
| Weight increased | Investigations | MedDRA 25.0 | Systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA 25.0 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Hypercholesterolaemia | Metabolism and nutrition disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Hypertriglyceridaemia | Metabolism and nutrition disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Hyperuricaemia | Metabolism and nutrition disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Hypochloraemia | Metabolism and nutrition disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Hypoproteinaemia | Metabolism and nutrition disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Cancer pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 25.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Proteinuria | Renal and urinary disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Hiccups | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 25.0 | Systematic Assessment |
|
BeiGene has 18 months from the end of the study at all sites to publish overall study results. After the 1st multi-site publication or the expiration of publication period, Investigators are free to publish/present the results of the study. Investigators must submit all draft publications/presentations to us for review 60 days prior to the planned publication/presentation date. BeiGene may request deletion of its confidential information & may request a further delay to protect its IP rights.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | BeiGene | 1-877-828-5568 | clinicaltrials@beigene.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 18, 2020 | Apr 11, 2024 | SAP_001.pdf |
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000707970 | tislelizumab |
| D002945 | Cisplatin |
| D016190 | Carboplatin |
| D000068437 | Pemetrexed |
| ID | Term |
|---|---|
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D006147 | Guanine |
| D007042 | Hypoxanthines |
| D011688 | Purinones |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D005971 | Glutamates |
| D024342 | Amino Acids, Acidic |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D000600 | Amino Acids, Dicarboxylic |
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Current |
|
| Former |
|
| 1%-49% |
|
| ≥ 50% |
|
| Unevaluable |
|
|
|
|
|
|
|
|
|
|
|
|
|
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| Participants |
|
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| Participants |
|
|