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| ID | Type | Description | Link |
|---|---|---|---|
| 2022-001779-15 | EudraCT Number | ||
| SAFFRON-301 | Other Identifier | BeiGene | |
| CTR20211410/CTR20211409 | Other Identifier | ChinaDrugTrials |
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Due to safety risks and unfavorable risk-benefit assessment results, the sponsor has decided to voluntarily terminate the study.
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The purpose of this study was to evaluate the efficacy and safety of tislelizumab in combination with sitravatinib compared to docetaxel in participants with locally advanced or metastatic non-small cell lung cancer (NSCLC) who experienced disease progression following platinum-based chemotherapy and anti-programmed cell death protein-1 (PD-1)/programmed cell death ligand-1 (PD-L1) antibody treatment, with the anti-PD-(L)1 antibody administered either in combination with or sequentially before or after the platinum-based chemotherapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tislelizumab + Sitravatinib | Experimental | Participants received 200 mg of intravenous tislelizumab every 3 weeks, combined with 100 mg of oral sitravatinib daily until disease progression, intolerable toxicity, death, or withdrawal of consent, whichever occurred earlier. |
|
| Docetaxel | Active Comparator | Participants received 75 mg/m² of intravenous docetaxel once every 3 weeks until disease progression, intolerable toxicity, death, or withdrawal of consent, whichever occurred earlier. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tislelizumab | Drug | 200 mg intravenously once every 3 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS) | Defined as the time from randomization until the date of death due to any cause. Kaplan-Meier methodology was used to estimate the median OS. | Until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive (a median follow-up of approximately 8 months). |
| Progression Free Survival (PFS) as Assessed by the Independent Review Committee (IRC) | Defined as the time from randomization until first documentation of disease progression as assessed by the IRC based on Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, or death from any cause, whichever occured first. Kaplan-Meier methodology was used to estimate the median PFS. | Until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive (a median follow-up of approximately 8 months). |
| Measure | Description | Time Frame |
|---|---|---|
| Progression Free Survival (PFS) as Assessed by the Investigator | Defined as the time from randomization until first documentation of disease progression as determined by the investigator based on RECIST v1.1, or death from any cause, whichever occured first. Kaplan-Meier methodology was used to estimate the median PFS. | Until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive (a median follow-up of approximately 8 months). |
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Key Inclusion Criteria:
Key Exclusion Criteria:
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Blacktown Cancer and Haematology Centre | Blacktown | New South Wales | 2148 | Australia | ||
| Campbelltown Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | Zhou Q, Zhao J, Gao B, et al. SAFFRON-301: A Phase 3 Study of Tislelizumab With Sitravatinib Versus Chemotherapy in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer Previously Treated With Platinum-Based Chemotherapy and an Anti-PD-1/PD-L1 Antibody. Poster presented at: ESMO Congress 2022; September, 2022; Paris, France. | ||
| Result | Zhou Q, Gao B, et al. SAFFRON-301: Sitravatinib PLUS Tislelizumab in Advanced/Metastatic NSCLC Progressing on/after Chemotherapy and Anti-PD-(L)1. | ||
| 41737914 | Derived | Zhou Q, Gao B, Hu J, Zhao J, Wang M, He K, Zhang W, Liu C, Fang J, Li XY, Wang Z, Matos M, Kwatra V, Zheng W, Wang C, Chen Y, Zhang J, Wang J, Wu YL. SAFFRON-301: a randomised phase III study of sitravatinib in combination with tislelizumab in patients with locally advanced or metastatic non-small cell lung cancer. BMJ Oncol. 2026 Feb 19;5(1):e000890. doi: 10.1136/bmjonc-2025-000890. eCollection 2026. |
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Patients were randomized in a 1:1 ratio to one of two treatment groups.
Participants were enrolled across multiple study centers in China and Australia. The first participant was dosed on July 27th, 2021, and the last participant completed the study on December 20th, 2023. A decision to terminate the study was made on September 25th, 2023.
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| ID | Title | Description |
|---|---|---|
| FG000 | Tislelizumab + Sitravatinib | Participants received 200 mg of intravenous tislelizumab every 3 weeks, combined with 100 mg of oral sitravatinib daily. |
| FG001 | Docetaxel | Participants received 75 mg/m² of intravenous docetaxel every 3 weeks. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 9, 2022 | Nov 25, 2024 |
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| Docetaxel | Drug | 75 mg/m^2 intravenously once every 3 weeks |
|
| Sitravatinib | Drug | 100 mg orally once daily |
|
|
| Overall Response Rate (ORR) | Defined as the percentage of participants with a confirmed complete response (CR) or partial response (PR) as assessed by the IRC per RECIST v1.1. | Until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive (a median follow-up of approximately 8 months). |
| Duration of Response (DOR) | Defined as the time from the first occurrence of a documented objective response to the time of the first occurrence of disease progression, as determined by the IRC based on RECIST v1.1, or death from any cause, whichever occurs first. | Until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive (a median follow-up of approximately 8 months). |
| Disease Control Rate (DCR) | Defined as the percentage of participants whose best overall response (BOR) is complete response, partial response, or stable disease per RECIST v1.1. | Until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive (a median follow-up of approximately 8 months). |
| 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 (GHS) and Physical Functioning Scores | The EORTC QLQ-30 contains 30 questions that incorporate 5 functional scales (physical functioning, role functioning, emotional functioning, cognitive functioning, and social functioning), 1 global health status scale, 3 symptom scales (fatigue, nausea and vomiting, and pain), and 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). The participant answers questions about their health during the past week. There are 28 questions answered on a 4-point scale where 1 = Not at all (best) and 4 = Very Much (worst) and 2 global health quality of life (QOL) questions answered on a 7-point scale where 1 = Very poor and 7 = Excellent. Raw scores are transformed into a 0 to 100 scale via linear transformation. Higher scores in GHS and functional scales indicate better quality of life. | Baseline and Cycle 5 Day 1 (Week 12) and Cycle 7 Day 1 (Week 18) |
| Change From Baseline in EORTC Quality of Life Questionnaire-Lung Cancer 13 (QLQ-LC13) Coughing, Dyspnoea, and Chest Pain Scales | The EORTC QLQ-LC13 is the lung cancer module of the QLQ-C30 and measures lung cancer-specific disease and treatment symptoms. It includes 13 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. Lower scores indicate an improvement in symptoms. | Baseline and Cycle 5 Day 1 (Week 12) and Cycle 7 Day 1 (Week 18) |
| Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D-5L) Visual Analogue Scale (VAS) | The EQ-5D-5L comprises a descriptive module that includes five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression and a Visual Analogue Scale. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The VAS records a participant's self-rated health on a vertical scale from 0 to 100, where 0 is 'the worst health you can imagine and 100 is 'the best health you can imagine'. A higher score indicates better health outcomes. | Baseline and Cycle 5 Day 1 (Week 12) and Cycle 7 Day 1 (Week 18) |
| Number of Participants With Adverse Events | Number of participants with treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs), according to National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) v5.0 | From the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). |
| Campbelltown |
| New South Wales |
| 2560 |
| Australia |
| The Tweed Valley Hospital | Cudgen | New South Wales | 2487 | Australia |
| St George Hospital | Kogarah | New South Wales | 2217 | Australia |
| Pindara Private Hospital | Benowa | Queensland | 4217 | Australia |
| Cancer Research South Australia | Adelaide | South Australia | 5000 | Australia |
| Monash Health | Clayton | Victoria | 3168 | Australia |
| St Vincents Hospital Melbourne | Fitzroy | Victoria | 3065 | Australia |
| Sunshine Hospital | St Albans | Victoria | 3021 | Australia |
| Anhui Provincial Cancer Hospital Aka West Branch of Anhui Province Hospital | Hefei | Anhui | 230088 | China |
| Beijing Cancer Hospital | Beijing | Beijing Municipality | 100142 | China |
| Peking Union Medical College Hospital | Beijing | Beijing Municipality | 100730 | China |
| Xinqiao Hospital Affiliated to the Army Medical University | Chongqing | Chongqing Municipality | 400037 | China |
| Daping Hospital, Third Military Medical University | Chongqing | Chongqing Municipality | 400042 | China |
| Fujian Provincial Hospital | Fuzhou | Fujian | 350001 | China |
| Fujian Cancer Hospital | Fuzhou | Fujian | 350014 | China |
| The First Affiliated Hospital of Xiamen University | Xiamen | Fujian | 361003 | China |
| The First Hospital of Lanzhou University | Lanzhou | Gansu | 730000 | China |
| Cancer Center of Guangzhou Medical University | Guangzhou | Guangdong | 510030 | China |
| Guangdong Provincial Peoples Hospital | Guangzhou | Guangdong | 510080 | China |
| Nanfang Hospital of Southern Medical University | Guangzhou | Guangdong | 510515 | China |
| Cancer Hospital of Shantou University Medical College | Shantou | Guangdong | 515031 | China |
| Cancer Hospital Chinse Academy of Medical Sciences, Shenzhen Center | Shenzhen | Guangdong | 518116 | China |
| The Peoples Hospital of Guangxi Zhuang Autonomous Region | Nanning | Guangxi | 530021 | China |
| The Tumor Hospital Affiliated to Guangxi Medical University | Nanning | Guangxi | 530021 | 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 |
| Union Hospital of Tongji Medical College, Huazhong University of Science and Technology | Wuhan | Hubei | 430022 | China |
| Tongji Hospital of Tongji Medical College Huazhong University of Science and Technology | Wuhan | Hubei | 430030 | China |
| Hubei Cancer Hospital | Wuhan | Hubei | 430079 | China |
| The Second Xiangya Hospital of Central South University | Changsha | Hunan | 410011 | China |
| The First Peoples Hospital of Chenzhou | Chenzhou | Hunan | 423000 | China |
| The Second Hospital, University of South China | Hengyang | Hunan | 430407 | China |
| Changzhou No Peoples Hospital, the Affiliated Hospital of Nanjing Medical University Branch Cheng | Changzhou | Jiangsu | 213003 | China |
| Nanjing First Hospital | Nanjing | Jiangsu | 210009 | China |
| Zhongda Hospital Southeast University | Nanjing | Jiangsu | 210009 | China |
| The Second Affiliated Hospital of Soochow University | Suzhou | Jiangsu | 215000 | China |
| The First Affiliated Hospital of Soochow University | Suzhou | Jiangsu | 215006 | China |
| The Affiliated Hospital of Xuzhou Medical University | Xuzhou | Jiangsu | 221000 | China |
| The First Affiliated Hospital of Nanchang University Branch Donghu | Nanchang | Jiangxi | 330006 | China |
| The Second Affiliated Hospital of Nanchang University | Nanchang | Jiangxi | 330006 | China |
| The First Hospital of Jilin University | Changchun | Jilin | 130021 | China |
| First Affiliated Hospital of Dalian Medical University | Dalian | Liaoning | 116011 | China |
| Liaoning Cancer Hospital and Institute | Shenyang | Liaoning | 110042 | China |
| General Hospital of Ningxia Medical University | Yinchuan | Ningxia | 750004 | China |
| Jinan Central Hospital | Jinan | Shandong | 250013 | China |
| Shandong Cancer Hospital | Jinan | Shandong | 250117 | China |
| The Affiliated Hospital of Qingdao University Branch Laoshan | Qingdao | Shandong | 266000 | China |
| Rui Jin Hospital Shanghai Jiao Tong University School of Medicine | Shanghai | Shanghai Municipality | 200025 | China |
| Affiliated Zhongshan Hospital of Fudan University | Shanghai | Shanghai Municipality | 200032 | China |
| Huashan Hospital Affiliated to Fudan University | Shanghai | Shanghai Municipality | 200040 | China |
| Sichuan Cancer Hospital and Institute | Chengdu | Sichuan | 610041 | 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 |
| Affiliated Cancer Hospital of Xinjiang Medical University | Ürümqi | Xinjiang | 830000 | China |
| Yunnan Cancer Hospital | Kunming | Yunnan | 650100 | China |
| Sir Run Run Shaw Hospital, Zhejiang University School of Medicine | Hangzhou | Zhejiang | 310016 | China |
| Zhejiang Cancer Hospital | Hangzhou | Zhejiang | 310022 | China |
| Taizhou Hospital of Zhejiang | Taizhou | Zhejiang | 317000 | China |
| Treated |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
The Intent-to-Treat (ITT) analysis set consists of all participants who were randomized to a treatment arm.
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| ID | Title | Description |
|---|---|---|
| BG000 | Tislelizumab + Sitravatinib | Participants received 200 mg of intravenous tislelizumab every 3 weeks, combined with 100 mg of oral sitravatinib daily. |
| BG001 | Docetaxel | Participants received 75 mg/m² of intravenous docetaxel every 3 weeks. |
| 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 | Mean | Standard Deviation | Years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||
| Histology | Count of Participants | Participants |
| ||||||||||||||||
| PD-L1 Expression Status | Participants whose tissues were unevaluable for PD-L1 expression were included in the < 1% tumor cells group during randomization stratification. | Count of Participants | Participants |
|
| 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 | Overall Survival (OS) | Defined as the time from randomization until the date of death due to any cause. Kaplan-Meier methodology was used to estimate the median OS. | The Intent-to-Treat (ITT) analysis set consists of all participants who were randomized to a treatment arm. | Posted | Median | 95% Confidence Interval | Months | Until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive (a median follow-up of approximately 8 months). |
|
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| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Progression Free Survival (PFS) as Assessed by the Independent Review Committee (IRC) | Defined as the time from randomization until first documentation of disease progression as assessed by the IRC based on Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, or death from any cause, whichever occured first. Kaplan-Meier methodology was used to estimate the median PFS. | ITT Analysis Set | Posted | Median | 95% Confidence Interval | Months | Until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive (a median follow-up of approximately 8 months). |
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| Secondary | Progression Free Survival (PFS) as Assessed by the Investigator | Defined as the time from randomization until first documentation of disease progression as determined by the investigator based on RECIST v1.1, or death from any cause, whichever occured first. Kaplan-Meier methodology was used to estimate the median PFS. | ITT Analysis Set | Posted | Median | 95% Confidence Interval | Months | Until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive (a median follow-up of approximately 8 months). |
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| Secondary | Overall Response Rate (ORR) | Defined as the percentage of participants with a confirmed complete response (CR) or partial response (PR) as assessed by the IRC per RECIST v1.1. | ITT Analysis Set | Posted | Number | 95% Confidence Interval | percentage of participants | Until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive (a median follow-up of approximately 8 months). |
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| Secondary | Duration of Response (DOR) | Defined as the time from the first occurrence of a documented objective response to the time of the first occurrence of disease progression, as determined by the IRC based on RECIST v1.1, or death from any cause, whichever occurs first. | ITT Analysis Set. Only participants with best overall response of complete response or partial response confirmed per RECIST v1.1 were included in the analysis, and percentages were based on the number of responders. | Posted | Median | 95% Confidence Interval | months | Until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive (a median follow-up of approximately 8 months). |
|
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| Secondary | Disease Control Rate (DCR) | Defined as the percentage of participants whose best overall response (BOR) is complete response, partial response, or stable disease per RECIST v1.1. | ITT Analysis Set. | Posted | Number | 95% Confidence Interval | percentage of participants | Until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive (a median follow-up of approximately 8 months). |
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| 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 (GHS) and Physical Functioning Scores | The EORTC QLQ-30 contains 30 questions that incorporate 5 functional scales (physical functioning, role functioning, emotional functioning, cognitive functioning, and social functioning), 1 global health status scale, 3 symptom scales (fatigue, nausea and vomiting, and pain), and 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). The participant answers questions about their health during the past week. There are 28 questions answered on a 4-point scale where 1 = Not at all (best) and 4 = Very Much (worst) and 2 global health quality of life (QOL) questions answered on a 7-point scale where 1 = Very poor and 7 = Excellent. Raw scores are transformed into a 0 to 100 scale via linear transformation. Higher scores in GHS and functional scales indicate better quality of life. | Participants in the ITT Analysis Set with available at Baseline and each postbaseline visit | Posted | Mean | Standard Deviation | score on a scale | Baseline and Cycle 5 Day 1 (Week 12) and Cycle 7 Day 1 (Week 18) |
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| Secondary | Change From Baseline in EORTC Quality of Life Questionnaire-Lung Cancer 13 (QLQ-LC13) Coughing, Dyspnoea, and Chest Pain Scales | The EORTC QLQ-LC13 is the lung cancer module of the QLQ-C30 and measures lung cancer-specific disease and treatment symptoms. It includes 13 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. Lower scores indicate an improvement in symptoms. | Participants in the ITT Analysis Set with available data at Baseline and each postbaseline visit | Posted | Mean | Standard Deviation | score on a scale | Baseline and Cycle 5 Day 1 (Week 12) and Cycle 7 Day 1 (Week 18) |
|
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| Secondary | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D-5L) Visual Analogue Scale (VAS) | The EQ-5D-5L comprises a descriptive module that includes five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression and a Visual Analogue Scale. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The VAS records a participant's self-rated health on a vertical scale from 0 to 100, where 0 is 'the worst health you can imagine and 100 is 'the best health you can imagine'. A higher score indicates better health outcomes. | Participants in the ITT Analysis Set with available at Baseline and each postbaseline visit | Posted | Mean | Standard Deviation | score on a scale | Baseline and Cycle 5 Day 1 (Week 12) and Cycle 7 Day 1 (Week 18) |
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| Secondary | Number of Participants With Adverse Events | Number of participants with treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs), according to National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) v5.0 | The Safety analysis set includes all participants who were randomized and received any dose of any study drug | Posted | Count of Participants | Participants | From the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). |
|
|
All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2).
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Tislelizumab + Sitravatinib | Participants received 200 mg of intravenous tislelizumab every 3 weeks, combined with 100 mg of oral sitravatinib daily. | 92 | 187 | 83 | 186 | 181 | 186 |
| EG001 | Docetaxel | Participants received 75 mg/m² of intravenous docetaxel every 3 weeks. | 82 | 190 | 66 | 177 | 150 | 177 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Disseminated intravascular coagulation | 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 |
| |
| Neutropenia | Blood and lymphatic system disorders | meddra 25.0 | Systematic Assessment |
| |
| Splenic infarction | 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 |
| |
| Cardiogenic shock | Cardiac disorders | meddra 25.0 | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | meddra 25.0 | Systematic Assessment |
| |
| Supraventricular tachycardia | Cardiac disorders | meddra 25.0 | Systematic Assessment |
| |
| Adrenal insufficiency | Endocrine disorders | meddra 25.0 | Systematic Assessment |
| |
| Immune-mediated hypophysitis | 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 |
| |
| Ascites | Gastrointestinal disorders | meddra 25.0 | Systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | meddra 25.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | meddra 25.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | meddra 25.0 | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | meddra 25.0 | Systematic Assessment |
| |
| Gastrointestinal perforation | Gastrointestinal disorders | meddra 25.0 | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | meddra 25.0 | Systematic Assessment |
| |
| Immune-mediated enterocolitis | Gastrointestinal disorders | meddra 25.0 | Systematic Assessment |
| |
| Intestinal obstruction | Gastrointestinal disorders | meddra 25.0 | Systematic Assessment |
| |
| Oesophageal fistula | Gastrointestinal disorders | meddra 25.0 | Systematic Assessment |
| |
| Oesophageal perforation | Gastrointestinal disorders | meddra 25.0 | Systematic Assessment |
| |
| Pancreatitis | Gastrointestinal disorders | meddra 25.0 | Systematic Assessment |
| |
| Pancreatitis acute | Gastrointestinal disorders | meddra 25.0 | Systematic Assessment |
| |
| Chest discomfort | General disorders | meddra 25.0 | Systematic Assessment |
| |
| Death | General disorders | meddra 25.0 | Systematic Assessment |
| |
| Fatigue | General disorders | meddra 25.0 | Systematic Assessment |
| |
| General physical health deterioration | General disorders | meddra 25.0 | Systematic Assessment |
| |
| Malaise | General disorders | meddra 25.0 | Systematic Assessment |
| |
| Multiple organ dysfunction syndrome | General disorders | meddra 25.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | meddra 25.0 | Systematic Assessment |
| |
| Drug-induced liver injury | Hepatobiliary disorders | meddra 25.0 | Systematic Assessment |
| |
| Hepatic function abnormal | Hepatobiliary disorders | meddra 25.0 | Systematic Assessment |
| |
| Immune-mediated hepatitis | Hepatobiliary disorders | meddra 25.0 | Systematic Assessment |
| |
| Appendicitis | Infections and infestations | meddra 25.0 | Systematic Assessment |
| |
| Biliary tract infection | Infections and infestations | meddra 25.0 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | meddra 25.0 | Systematic Assessment |
| |
| COVID-19 pneumonia | Infections and infestations | meddra 25.0 | Systematic Assessment |
| |
| Febrile infection | Infections and infestations | meddra 25.0 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | meddra 25.0 | Systematic Assessment |
| |
| Herpes zoster | Infections and infestations | meddra 25.0 | Systematic Assessment |
| |
| Infection | Infections and infestations | meddra 25.0 | Systematic Assessment |
| |
| Joint abscess | Infections and infestations | meddra 25.0 | Systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | meddra 25.0 | Systematic Assessment |
| |
| Pharyngitis | Infections and infestations | meddra 25.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | meddra 25.0 | Systematic Assessment |
| |
| Scrotal infection | Infections and infestations | meddra 25.0 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | meddra 25.0 | Systematic Assessment |
| |
| Radiation pneumonitis | 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 bilirubin increased | Investigations | meddra 25.0 | Systematic Assessment |
| |
| Electrocardiogram QT prolonged | Investigations | meddra 25.0 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | meddra 25.0 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | meddra 25.0 | Systematic Assessment |
| |
| SARS-CoV-2 test positive | 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 |
| |
| Diabetic ketoacidosis | Metabolism and nutrition disorders | meddra 25.0 | Systematic Assessment |
| |
| Hypercalcaemia | Metabolism and nutrition disorders | meddra 25.0 | Systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | meddra 25.0 | Systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | meddra 25.0 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | meddra 25.0 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | meddra 25.0 | Systematic Assessment |
| |
| Hypoproteinaemia | Metabolism and nutrition disorders | meddra 25.0 | Systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | meddra 25.0 | Systematic Assessment |
| |
| Gouty arthritis | Musculoskeletal and connective tissue disorders | meddra 25.0 | Systematic Assessment |
| |
| Immune-mediated myositis | Musculoskeletal and connective tissue disorders | meddra 25.0 | Systematic Assessment |
| |
| Osteoporosis | Musculoskeletal and connective tissue disorders | meddra 25.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | meddra 25.0 | Systematic Assessment |
| |
| Pathological fracture | 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 |
| |
| Lymphangiosis carcinomatosa | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | meddra 25.0 | Systematic Assessment |
| |
| Metastases to central nervous system | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | meddra 25.0 | Systematic Assessment |
| |
| Pericardial effusion malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | meddra 25.0 | Systematic Assessment |
| |
| Migraine | Nervous system disorders | meddra 25.0 | Systematic Assessment |
| |
| Transient ischaemic attack | Nervous system disorders | meddra 25.0 | Systematic Assessment |
| |
| Delirium | Psychiatric disorders | meddra 25.0 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | meddra 25.0 | Systematic Assessment |
| |
| Immune-mediated nephritis | Renal and urinary disorders | meddra 25.0 | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | meddra 25.0 | Systematic Assessment |
| |
| Bronchopleural fistula | 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 |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | meddra 25.0 | Systematic Assessment |
| |
| Immune-mediated lung disease | Respiratory, thoracic and mediastinal disorders | meddra 25.0 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | meddra 25.0 | Systematic Assessment |
| |
| Pleuritic pain | Respiratory, thoracic and mediastinal disorders | meddra 25.0 | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | meddra 25.0 | Systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | meddra 25.0 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | meddra 25.0 | Systematic Assessment |
| |
| Pulmonary infarction | Respiratory, thoracic and mediastinal disorders | meddra 25.0 | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | meddra 25.0 | Systematic Assessment |
| |
| Dermatitis allergic | Skin and subcutaneous tissue disorders | meddra 25.0 | Systematic Assessment |
| |
| Palmar-plantar erythrodysaesthesia syndrome | Skin and subcutaneous tissue disorders | meddra 25.0 | Systematic Assessment |
| |
| Aortic dissection | Vascular disorders | meddra 25.0 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | meddra 25.0 | Systematic Assessment |
| |
| Shock | Vascular disorders | meddra 25.0 | Systematic Assessment |
| |
| Varicose vein | 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 |
| |
| Neutropenia | Blood and lymphatic system disorders | meddra 25.0 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | meddra 25.0 | Systematic Assessment |
| |
| Sinus bradycardia | Cardiac disorders | meddra 25.0 | Systematic Assessment |
| |
| Sinus tachycardia | Cardiac 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 |
| |
| Dry mouth | Gastrointestinal disorders | meddra 25.0 | Systematic Assessment |
| |
| Mouth ulceration | Gastrointestinal disorders | meddra 25.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | meddra 25.0 | Systematic Assessment |
| |
| Stomatitis | 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 |
| |
| Fatigue | 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 |
| |
| Pain | 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 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 lactate dehydrogenase increased | Investigations | meddra 25.0 | Systematic Assessment |
| |
| Blood pressure increased | 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 |
| |
| C-reactive protein increased | Investigations | meddra 25.0 | Systematic Assessment |
| |
| Electrocardiogram QT prolonged | Investigations | meddra 25.0 | Systematic Assessment |
| |
| Gamma-glutamyltransferase increased | Investigations | meddra 25.0 | Systematic Assessment |
| |
| Lymphocyte count decreased | Investigations | meddra 25.0 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | meddra 25.0 | Systematic Assessment |
| |
| Neutrophil count increased | Investigations | meddra 25.0 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | meddra 25.0 | Systematic Assessment |
| |
| Protein urine present | Investigations | meddra 25.0 | Systematic Assessment |
| |
| SARS-CoV-2 test positive | Investigations | meddra 25.0 | Systematic Assessment |
| |
| Weight decreased | Investigations | meddra 25.0 | Systematic Assessment |
| |
| White blood cell count decreased | Investigations | meddra 25.0 | Systematic Assessment |
| |
| White blood cells urine positive | 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 |
| |
| Hyperlipidaemia | 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 |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | meddra 25.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | meddra 25.0 | Systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | meddra 25.0 | Systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | meddra 25.0 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | meddra 25.0 | Systematic Assessment |
| |
| Haematuria | Renal and urinary 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 |
| |
| Dysphonia | 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 |
| |
| Oropharyngeal pain | 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 |
| |
| Palmar-plantar erythrodysaesthesia syndrome | 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 | Nov 9, 2023 | Nov 25, 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 |
| D000077143 | Docetaxel |
| C000611865 | sitravatinib |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
Not provided
Not provided
| Male |
|
| White |
|
| Australia |
|
| Non-squamous |
|
| < 1% Tumor Cells |
|
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