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| ID | Type | Description | Link |
|---|---|---|---|
| CTR20211874 | Other Identifier | ChinaDrugTrials |
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This clinical trial evaluated the safety and potential benefits of combining two cancer treatments, tislelizumab and lenvatinib, in Chinese participants with advanced or metastatic cancers, including lung, head and neck, bladder, kidney, and stomach cancer. The study included two parts: the first part assessed how safe the drug combination was, and the second part examined how well it worked.
A small group of participants initially received the drugs to determine the appropriate dose, and if the treatment was well tolerated, additional participants were treated at that dose. Participants remained on the treatment unless their cancer progressed, they experienced serious side effects, or they chose to stop.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Safety Run In | Experimental | Participants with advanced or metastatic unresectable solid tumors were enrolled to receive 400 mg of tislelizumab administered on Day 1 of each 6-week cycle, along with 20 mg of lenvatinib self-administered orally once daily, to determine the recommended Part 2 dose (RP2D). |
|
| Part 2: Squamous Cell Carcinoma of the Head and Neck (SCCHN) Cohort | Experimental | Participants with previously untreated, advanced or metastatic SCCHN received tislelizumab (400 mg administered intravenously [IV] every 6 weeks [Q6W]) in combination with lenvatinib (20 mg taken orally once daily [QD]) until disease progression, start of new anticancer therapy, unacceptable toxicity, withdrawal of consent, or study termination. |
|
| Part 2: Renal Cell Carcinoma (RCC) Cohort | Experimental | Systemic therapy naive participants with advanced or metastatic RCC received tislelizumab (400 mg IV Q6W) plus lenvatinib (20 mg orally QD) until disease progression, start of new anticancer therapy, unacceptable toxicity, withdrawal of consent, or study termination. |
|
| Part 2: Non-Small Cell Lung Cancer (NSCLC) Cohort | Experimental | Participants with NSCLC expressing programmed cell death-ligand 1 (PD-L1) in ≥1% of tumor cells (TC ≥1%) and who had not received prior systemic therapy received tislelizumab (400 mg IV Q6W) and lenvatinib (20 mg orally QD) until disease progression, start of new anticancer therapy, unacceptable toxicity, withdrawal of consent, or study termination; this cohort was closed early based on emerging external data. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| lenvatinib | Drug | Administered at the dose of 20 mg orally, once daily. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety Run-in: Number of Participants With Adverse Events (AEs) | An adverse event refers to any unintended or unfavorable sign, symptom, or condition (including abnormal lab results) that occurs during the study, regardless of whether it is related to the study drug. A serious adverse event (SAE) is any untoward medical occurrence that, at any dose:
A dose-limiting toxicity (DLT) was defined as a Grade 3 or 4 hematologic or nonhematologic toxicity occurring during the DLT assessment window and deemed related to one or more study drugs by the investigator. | From first dose through the end of the safety run-in part, up to 124 days; The DLT observation period was 28 days after first dose. |
| Overall Response Rate (ORR) | Overall response rate is defined as the percentage of participants who had a confirmed complete response (CR) or partial response (PR) as assessed by the investigator per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 Tumor assessments. CR is defined as the disappearance of all target and non-target lesions and no new lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm. PR is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. | From the first dose up to the primary analysis data cut-off date of 10 October 2023 (maximum time on study was 24.7 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Progression Free Survival (PFS) | PFS was defined as the time from randomization to the first objectively documented disease progression as assessed by the investigator per Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST v1.1) or death from any cause, whichever occurred first. Median PFS was estimated using the Kaplan-Meier method. | From the first dose up to the primary analysis data cut-off date of 10 October 2023 (maximum time on study was 24.7 months) |
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Key Inclusion Criteria:
Participants had signed an informed consent form and were able to comply with all study requirements.
Participants had a histologically and/or cytologically confirmed diagnosis of advanced solid tumors, which included one of the following types:
Participants had at least one measurable lesion as defined by the Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1.
Tumor tissue samples (approximately 10 unstained slides) were provided for central laboratory assessment of programmed death-ligand 1 (PD-L1) expression in the NSCLC cohort during the screening period. These samples were also used for retrospective exploratory biomarker analyses related to treatment response and resistance across the NSCLC, SCCHN, UC, or Gastric Cancer (GC) cohorts, in a central or designated test laboratory approved by BeiGene.
Participants had an Eastern Cooperative Oncology Group (ECOG) performance of 0 or 1
Key Exclusion Criteria:
Note: Additional protocol-defined inclusion and exclusion criteria may have applied.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Second Hospital of Anhui Medical University | Hefei | Anhui | 230601 | China | ||
| Peking University First Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | BGB-A317-212: A Multicenter, Open-label, Phase II Study to Evaluate the Efficacy and Safety of Tislelizumab in Combination With Lenvatinib in Patients With Selected Solid Tumors. Poster No: 2610 presented at ASCO, Chicago, IL, May 31-June 4, 2024 |
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BeiGene shares data on completed studies responsibly and provides qualified scientific and medical researchers access to data and supporting documentation for clinical trials in dossiers for medicines and indications after submission and approval in the United States, China, and Europe.
Clinical trials supporting subsequent local approvals, new indications, or combination products are eligible for sharing once corresponding regulatory approvals are achieved. BeiGene shares data only when permitted by applicable data privacy and security laws and regulations, when it is feasible to do so without compromising the privacy of study participants, and other considerations.
Qualified researchers with appropriate competencies who are engaged in novel scientific research may submit a request for participant-level data with a research proposal for BeiGene review. Research teams must include a biostatistician and sign a Data Sharing Agreement prior to receiving access to clinical trial data.
See plan description
See plan description
This study included a safety run-in and expansion phase to evaluate treatment with tislelizumab plus lenvatinib. All participants enrolled in the run-in phase continued into the expansion phase and all participants received the same treatment dose. According to the planned analysis, all enrolled participants were analyzed together (including those who enrolled in the run-in phase) based on tumor type.
Participants were enrolled in multiple study centers in China. The first participant dosed was on September 18th, 2021 and the last participant completed on July 10th, 2024. Enrollment began with a run-in phase to assess the safety and tolerability of tislelizumab plus lenvatinib combination therapy. Once the Safety Monitoring Committee confirmed that the combination therapy was tolerable, enrollment into the expansion phase began.
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| ID | Title | Description |
|---|---|---|
| FG000 | Squamous Cell Carcinoma of the Head and Neck (SCCHN) | Participants with previously untreated, advanced or metastatic SCCHN received tislelizumab (400 mg administered intravenously [IV] every 6 weeks [Q6W]) in combination with lenvatinib (20 mg taken orally once daily [QD]) until disease progression, start of new anticancer therapy, unacceptable toxicity, withdrawal of consent, or study termination. |
| 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 | Nov 3, 2022 | Jun 30, 2025 |
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|
| Part 2: Gastric Cancer (GC) Cohort | Experimental | Participants with advanced GC who had received one prior line of systemic therapy were enrolled to receive tislelizumab and lenvatinib at the RP2D (tislelizumab 400 mg IV Q6W; lenvatinib 20 mg orally QD) until disease progression, start of new anticancer therapy, unacceptable toxicity, withdrawal of consent, or study termination; this cohort was closed early due to changes in the first-line standard of care. |
|
| Part 2: Urothelial Cancer (UC) Cohort | Experimental | Participants with cisplatin ineligible, systemic therapy naive advanced UC, were to be treated with tislelizumab (400 mg IV Q6W) and lenvatinib (20 mg orally QD). This cohort was closed prior to any participant enrollment based on emerging external data. |
|
| Tislelizumab | Drug | 400 mg administered intravenously on Day 1 of each 42-day cycle |
|
|
| Duration of Response (DOR) | DOR was defined as the time from the first documented objective response to documented radiological disease progression as assessed by the investigator using RECIST v1.1, or death from any cause, whichever occurred first. Median DOR was estimated using the Kaplan-Meier method. Progressive disease is captured as at least a 20% increase in the sum of diameters of target lesions, using the smallest sum on study as the reference (including the baseline sum if it was the smallest). In addition to the 20% relative increase, the sum also had to show an absolute increase of at least 5 mm. | From the first dose up to the primary analysis data cut-off date of 10 October 2023 (maximum time on study was 24.7 months) |
| Disease Control Rate (DCR) | DCR was defined as the percentage of participants who demonstrated a confirmed complete response (CR), partial response (PR), or stable disease (SD) as the best overall response, in accordance with the RECIST version 1.1 criteria. CR was defined as the disappearance of all target and non-target lesions with no new lesions observed. Any pathological lymph nodes (whether target or non-target) were required to have a reduction in short axis to less than 10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, using the baseline sum of diameters as the reference. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), using the smallest sum of diameters recorded while on study as the reference. | From the first dose up to the primary analysis data cut-off date of 10 October 2023 (maximum time on study was 24.7 months) |
| Overall Survival (OS) | OS was defined as the time from randomization to the documented date of death for participants who died on or before the data cutoff date. Median OS was calculated using the Kaplan-Meier method. Data for participants who were alive at the data cutoff date were censored at their last known alive date, defined as either the clinical cutoff date for those still on treatment or the most recent available date confirming they were alive, whichever occurred first. | From the first dose up to the primary analysis data cut-off date of 10 October 2023 (maximum time on study was 24.7 months) |
| Number of Participants Experiencing Adverse Events (AEs) | An adverse event refers to any unintended or unfavorable sign, symptom, or condition (including abnormal lab results) that occurs during the study, regardless of whether it is related to the study drug. | From first dose of study drug to 30 days after last dose, up to the study completion date of 10 July 2024 (up to 32.5 months) |
| Beijing |
| Beijing Municipality |
| 100034 |
| China |
| Beijing Friendship Hospital, Capital Medical University | Beijing | Beijing Municipality | 100050 | China |
| Beijing Cancer Hospital | Beijing | Beijing Municipality | 100142 | China |
| Beijing Luhe Hospital, Capital Medical University | Beijing | Beijing Municipality | 101149 | China |
| Chongqing Cancer Hospital | Chongqing | Chongqing Municipality | 400030 | China |
| The Peoples Hospital of Guangxi Zhuang Autonomous Region | Nanning | Guangxi | 530021 | China |
| Union Hospital of Tongji Medical College, Huazhong University of Science and Technology | Wuhan | Hubei | 430022 | China |
| Hunan Cancer Hospital | Changsha | Hunan | 410013 | China |
| Jiangsu Province Cancer Hospital | Nanjing | Jiangsu | 210008 | China |
| The First Affiliated Hospital of Nanchang University Branch Donghu | Nanchang | Jiangxi | 330006 | China |
| Zhejiang Provincial Peoples Hospital | Hangzhou | Zhejiang | 310014 | China |
| Zhejiang Cancer Hospital | Hangzhou | Zhejiang | 310022 | China |
| FG001 | Renal Cell Carcinoma (RCC) | Systemic therapy naive participants with advanced or metastatic RCC received tislelizumab (400 mg IV Q6W) plus lenvatinib (20 mg orally QD) until disease progression, start of new anticancer therapy, unacceptable toxicity, withdrawal of consent, or study termination |
| FG002 | Non-Small Cell Lung Cancer (NSCLC) | Participants with NSCLC expressing programmed cell death-ligand 1 (PD-L1) in ≥1% of tumor cells (TC ≥1%) and who had not received prior systemic therapy received tislelizumab (400 mg IV Q6W) and lenvatinib (20 mg orally QD) until disease progression, start of new anticancer therapy, unacceptable toxicity, withdrawal of consent, or study termination. |
| FG003 | Gastric Cancer (GC) | Participants with advanced GC who had received one prior line of systemic therapy were enrolled to receive tislelizumab and lenvatinib at the RP2D (tislelizumab 400 mg IV Q6W; lenvatinib 20 mg orally QD) until disease progression, start of new anticancer therapy, unacceptable toxicity, withdrawal of consent, or study termination; this cohort was closed early due to changes in the first-line standard of care. |
| Treated |
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| Enrolled in Safety Run-in Stage |
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| COMPLETED |
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| NOT COMPLETED |
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The Safety Analysis Set is defined as all participants who received ≥ 1 dose of study drug(s).
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| ID | Title | Description |
|---|---|---|
| BG000 | Squamous Cell Carcinoma of the Head and Neck (SCCHN) | Participants with previously untreated, advanced or metastatic SCCHN received tislelizumab (400 mg administered intravenously [IV] every 6 weeks [Q6W]) in combination with lenvatinib (20 mg taken orally once daily [QD]) until disease progression, start of new anticancer therapy, unacceptable toxicity, withdrawal of consent, or study termination. |
| BG001 | Renal Cell Carcinoma (RCC) | Systemic therapy naive participants with advanced or metastatic RCC received tislelizumab (400 mg IV Q6W) plus lenvatinib (20 mg orally QD) until disease progression, start of new anticancer therapy, unacceptable toxicity, withdrawal of consent, or study termination |
| BG002 | Non-Small Cell Lung Cancer (NSCLC) | Participants with NSCLC expressing programmed cell death-ligand 1 (PD-L1) in ≥1% of tumor cells (TC ≥1%) and who had not received prior systemic therapy received tislelizumab (400 mg IV Q6W) and lenvatinib (20 mg orally QD) until disease progression, start of new anticancer therapy, unacceptable toxicity, withdrawal of consent, or study termination; this cohort was closed early based on emerging external data. |
| BG003 | Gastric Cancer (GC) | Participants with advanced GC who had received one prior line of systemic therapy were enrolled to receive tislelizumab and lenvatinib at the RP2D (tislelizumab 400 mg IV Q6W; lenvatinib 20 mg orally QD) until disease progression, start of new anticancer therapy, unacceptable toxicity, withdrawal of consent, or study termination; this cohort was closed early due to changes in the first-line standard of care. |
| BG004 | 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 |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| 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 | Safety Run-in: Number of Participants With Adverse Events (AEs) | An adverse event refers to any unintended or unfavorable sign, symptom, or condition (including abnormal lab results) that occurs during the study, regardless of whether it is related to the study drug. A serious adverse event (SAE) is any untoward medical occurrence that, at any dose:
A dose-limiting toxicity (DLT) was defined as a Grade 3 or 4 hematologic or nonhematologic toxicity occurring during the DLT assessment window and deemed related to one or more study drugs by the investigator. | The Safety run-in set is defined as all participants in the safety run-in stage. | Posted | Count of Participants | Participants | From first dose through the end of the safety run-in part, up to 124 days; The DLT observation period was 28 days after first dose. |
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| Primary | Overall Response Rate (ORR) | Overall response rate is defined as the percentage of participants who had a confirmed complete response (CR) or partial response (PR) as assessed by the investigator per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 Tumor assessments. CR is defined as the disappearance of all target and non-target lesions and no new lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm. PR is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. | Safety Analysis Set: Participants who received ≥ 1 dose of study drug(s) Evaluable Analysis Set: Participants who received ≥ 1 dose of study drug(s), have evaluable disease at baseline, and have ≥ 1 evaluable postbaseline tumor response assessment unless any clinical progressive disease or death occurred before the first postbaseline tumor assessment. | Posted | Number | 95% Confidence Interval | Percentage of participants | From the first dose up to the primary analysis data cut-off date of 10 October 2023 (maximum time on study was 24.7 months) |
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| Secondary | Progression Free Survival (PFS) | PFS was defined as the time from randomization to the first objectively documented disease progression as assessed by the investigator per Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST v1.1) or death from any cause, whichever occurred first. Median PFS was estimated using the Kaplan-Meier method. | Safety analysis set | Posted | Median | 95% Confidence Interval | Months | From the first dose up to the primary analysis data cut-off date of 10 October 2023 (maximum time on study was 24.7 months) |
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| Secondary | Duration of Response (DOR) | DOR was defined as the time from the first documented objective response to documented radiological disease progression as assessed by the investigator using RECIST v1.1, or death from any cause, whichever occurred first. Median DOR was estimated using the Kaplan-Meier method. Progressive disease is captured as at least a 20% increase in the sum of diameters of target lesions, using the smallest sum on study as the reference (including the baseline sum if it was the smallest). In addition to the 20% relative increase, the sum also had to show an absolute increase of at least 5 mm. | Evaluable Analysis Set. Only participants with best overall response of complete response or partial response confirmed per RECIST v1.1 were included in this analysis, | Posted | Median | 95% Confidence Interval | Months | From the first dose up to the primary analysis data cut-off date of 10 October 2023 (maximum time on study was 24.7 months) |
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| Secondary | Disease Control Rate (DCR) | DCR was defined as the percentage of participants who demonstrated a confirmed complete response (CR), partial response (PR), or stable disease (SD) as the best overall response, in accordance with the RECIST version 1.1 criteria. CR was defined as the disappearance of all target and non-target lesions with no new lesions observed. Any pathological lymph nodes (whether target or non-target) were required to have a reduction in short axis to less than 10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, using the baseline sum of diameters as the reference. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), using the smallest sum of diameters recorded while on study as the reference. | Evaluable analysis set and Safety Analysis Set | Posted | Number | 95% Confidence Interval | Percentage of Participants | From the first dose up to the primary analysis data cut-off date of 10 October 2023 (maximum time on study was 24.7 months) |
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| Secondary | Overall Survival (OS) | OS was defined as the time from randomization to the documented date of death for participants who died on or before the data cutoff date. Median OS was calculated using the Kaplan-Meier method. Data for participants who were alive at the data cutoff date were censored at their last known alive date, defined as either the clinical cutoff date for those still on treatment or the most recent available date confirming they were alive, whichever occurred first. | Safety Analysis Set | Posted | Median | 95% Confidence Interval | Month | From the first dose up to the primary analysis data cut-off date of 10 October 2023 (maximum time on study was 24.7 months) |
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| Secondary | Number of Participants Experiencing Adverse Events (AEs) | An adverse event refers to any unintended or unfavorable sign, symptom, or condition (including abnormal lab results) that occurs during the study, regardless of whether it is related to the study drug. | Safety Analysis Set | Posted | Count of Participants | Participants | From first dose of study drug to 30 days after last dose, up to the study completion date of 10 July 2024 (up to 32.5 months) |
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All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
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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 | Squamous Cell Carcinoma of the Head and Neck (SCCHN) | Participants with previously untreated, advanced or metastatic SCCHN received tislelizumab (400 mg administered intravenously [IV] every 6 weeks [Q6W]) in combination with lenvatinib (20 mg taken orally once daily [QD]) until disease progression, start of new anticancer therapy, unacceptable toxicity, withdrawal of consent, or study termination. | 11 | 27 | 17 | 27 | 27 | 27 |
| EG001 | Renal Cell Carcinoma (RCC) | Systemic therapy naive participants with advanced or metastatic RCC received tislelizumab (400 mg IV Q6W) plus lenvatinib (20 mg orally QD) until disease progression, start of new anticancer therapy, unacceptable toxicity, withdrawal of consent, or study termination. | 6 | 23 | 11 | 23 | 21 | 23 |
| EG002 | Non-Small Cell Lung Cancer (NSCLC) | Participants with NSCLC expressing programmed cell death-ligand 1 (PD-L1) in ≥1% of tumor cells (TC ≥1%) and who had not received prior systemic therapy received tislelizumab (400 mg IV Q6W) and lenvatinib (20 mg orally QD) until disease progression, start of new anticancer therapy, unacceptable toxicity, withdrawal of consent, or study termination; this cohort was closed early based on emerging external data. | 0 | 5 | 2 | 5 | 5 | 5 |
| EG003 | Gastric Cancer (GC) | Participants with advanced GC who had received one prior line of systemic therapy were enrolled to receive tislelizumab and lenvatinib at the RP2D (tislelizumab 400 mg IV Q6W; lenvatinib 20 mg orally QD) until disease progression, start of new anticancer therapy, unacceptable toxicity, withdrawal of consent, or study termination; this cohort was closed early due to changes in the first-line standard of care. | 0 | 3 | 2 | 3 | 3 | 3 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Necrotic lymphadenopathy | Blood and lymphatic system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Arrhythmia | Cardiac disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Cardio-respiratory arrest | Cardiac disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Myocarditis | Cardiac disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Pancreatitis | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Pancreatitis acute | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Death | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Multiple organ dysfunction syndrome | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Cholecystitis acute | Hepatobiliary disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Hepatic function abnormal | Hepatobiliary disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| COVID-19 pneumonia | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Febrile infection | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Osteomyelitis | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Incision site haemorrhage | Injury, poisoning and procedural complications | MedDRA 26.0 | Systematic Assessment |
| |
| Traumatic intracranial haemorrhage | Injury, poisoning and procedural complications | MedDRA 26.0 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 26.0 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 26.0 | Systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Malnutrition | Metabolism and nutrition disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Haemorrhagic tumour necrosis | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.0 | Systematic Assessment |
| |
| Cerebral haemorrhage | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Cerebral infarction | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Proteinuria | Renal and urinary disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Uterine prolapse | Reproductive system and breast disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Immune-mediated lung disease | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Interstitial lung disease | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Laryngeal oedema | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Diabetic foot | Skin and subcutaneous tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Arterial haemorrhage | Vascular disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Peripheral arterial occlusive disease | Vascular disorders | MedDRA 26.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 26.0 | Systematic Assessment |
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| Hypercoagulation | Blood and lymphatic system disorders | MedDRA 26.0 | Systematic Assessment |
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| Leukopenia | Blood and lymphatic system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Lymphadenitis | Blood and lymphatic system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Thrombocytosis | Blood and lymphatic system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Angina pectoris | Cardiac disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Cardiac discomfort | Cardiac disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Palpitations | Cardiac disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Sinus arrhythmia | Cardiac disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Sinus bradycardia | Cardiac disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Supraventricular extrasystoles | Cardiac disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Supraventricular tachycardia | Cardiac disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Tinnitus | Ear and labyrinth disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Autoimmune thyroiditis | Endocrine disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Hyperthyroidism | Endocrine disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Hypothyroidism | Endocrine disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Periorbital oedema | Eye disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Alveolar bone defect | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Anal fissure | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Aphthous ulcer | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Chronic gastritis | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Gingival erosion | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Gingival pain | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Gingival swelling | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Haemorrhoids | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Loose tooth | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Mouth haemorrhage | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Mouth ulceration | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Oral disorder | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Oral pain | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Proctalgia | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Tooth loss | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Toothache | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Face oedema | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Facial pain | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Generalised oedema | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Influenza like illness | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Localised oedema | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Malaise | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Pain | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Hepatic function abnormal | Hepatobiliary disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Asymptomatic bacteriuria | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Fascial infection | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Gingivitis | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Hordeolum | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Laryngitis | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Laryngopharyngitis | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Periodontitis | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Rhinitis | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Tracheobronchitis | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Anal injury | Injury, poisoning and procedural complications | MedDRA 26.0 | Systematic Assessment |
| |
| Head injury | Injury, poisoning and procedural complications | MedDRA 26.0 | Systematic Assessment |
| |
| Lip injury | Injury, poisoning and procedural complications | MedDRA 26.0 | Systematic Assessment |
| |
| Post procedural haemorrhage | Injury, poisoning and procedural complications | MedDRA 26.0 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 26.0 | Systematic Assessment |
| |
| Amylase increased | Investigations | MedDRA 26.0 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 26.0 | Systematic Assessment |
| |
| Bile acids increased | Investigations | MedDRA 26.0 | Systematic Assessment |
| |
| Bilirubin conjugated decreased | Investigations | MedDRA 26.0 | Systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA 26.0 | Systematic Assessment |
| |
| Blood bilirubin increased | Investigations | MedDRA 26.0 | Systematic Assessment |
| |
| Blood cholesterol increased | Investigations | MedDRA 26.0 | Systematic Assessment |
| |
| Blood corticotrophin decreased | Investigations | MedDRA 26.0 | Systematic Assessment |
| |
| Blood creatine phosphokinase MB increased | Investigations | MedDRA 26.0 | Systematic Assessment |
| |
| Blood creatine phosphokinase increased | Investigations | MedDRA 26.0 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA 26.0 | Systematic Assessment |
| |
| Blood glucose increased | Investigations | MedDRA 26.0 | Systematic Assessment |
| |
| Blood lactate dehydrogenase increased | Investigations | MedDRA 26.0 | Systematic Assessment |
| |
| Blood thyroid stimulating hormone decreased | Investigations | MedDRA 26.0 | Systematic Assessment |
| |
| Blood thyroid stimulating hormone increased | Investigations | MedDRA 26.0 | Systematic Assessment |
| |
| Blood urea increased | Investigations | MedDRA 26.0 | Systematic Assessment |
| |
| Blood uric acid increased | Investigations | MedDRA 26.0 | Systematic Assessment |
| |
| C-reactive protein increased | Investigations | MedDRA 26.0 | Systematic Assessment |
| |
| Eosinophil count increased | Investigations | MedDRA 26.0 | Systematic Assessment |
| |
| Gamma-glutamyltransferase increased | Investigations | MedDRA 26.0 | Systematic Assessment |
| |
| Granulocyte count increased | Investigations | MedDRA 26.0 | Systematic Assessment |
| |
| Hepatobiliary scan abnormal | Investigations | MedDRA 26.0 | Systematic Assessment |
| |
| Lipase increased | Investigations | MedDRA 26.0 | Systematic Assessment |
| |
| Lymphocyte count decreased | Investigations | MedDRA 26.0 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA 26.0 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA 26.0 | Systematic Assessment |
| |
| Protein urine present | Investigations | MedDRA 26.0 | Systematic Assessment |
| |
| SARS-CoV-2 test positive | Investigations | MedDRA 26.0 | Systematic Assessment |
| |
| Troponin I increased | Investigations | MedDRA 26.0 | Systematic Assessment |
| |
| Troponin T increased | Investigations | MedDRA 26.0 | Systematic Assessment |
| |
| Urine ketone body present | Investigations | MedDRA 26.0 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA 26.0 | Systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA 26.0 | Systematic Assessment |
| |
| White blood cell count increased | Investigations | MedDRA 26.0 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Hyperlipidaemia | Metabolism and nutrition disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Hypertriglyceridaemia | Metabolism and nutrition disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Hyperuricaemia | Metabolism and nutrition disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Hypochloraemia | Metabolism and nutrition disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Hypoproteinaemia | Metabolism and nutrition disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Malnutrition | Metabolism and nutrition disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Neck mass | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Soft tissue swelling | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Trismus | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Cancer pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.0 | Systematic Assessment |
| |
| Infected neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.0 | Systematic Assessment |
| |
| Tumour haemorrhage | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.0 | Systematic Assessment |
| |
| Tumour necrosis | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Sciatica | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Dyssomnia | Psychiatric disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Albuminuria | Renal and urinary disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Chronic kidney disease | Renal and urinary disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Glomerulonephritis | Renal and urinary disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Hyperuricosuria | Renal and urinary disorders | MedDRA 26.0 | Systematic Assessment |
| |
| IgA nephropathy | Renal and urinary disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Ischaemic nephropathy | Renal and urinary disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Proteinuria | Renal and urinary disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Benign prostatic hyperplasia | Reproductive system and breast disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Scrotal ulcer | Reproductive system and breast disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Bronchial ulceration | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Oropharyngeal discomfort | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Dermatitis allergic | Skin and subcutaneous tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Immune-mediated dermatitis | Skin and subcutaneous tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Palmar-plantar erythrodysaesthesia syndrome | Skin and subcutaneous tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Purpura | Skin and subcutaneous tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 26.0 | 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 | Jun 30, 2025 | SAP_001.pdf |
| ID | Term |
|---|---|
| C531958 | lenvatinib |
| C000707970 | tislelizumab |
Not provided
Not provided
Not provided
| Male |
|
| Other |
|
| Title | Measurements |
|---|---|
|
| Renal Cell Carcinoma (RCC) |
Systemic therapy naive participants with advanced or metastatic RCC received tislelizumab (400 mg IV Q6W) plus lenvatinib (20 mg orally QD) until disease progression, start of new anticancer therapy, unacceptable toxicity, withdrawal of consent, or study termination. |
| OG002 | Non-Small Cell Lung Cancer (NSCLC) | Participants with NSCLC expressing programmed cell death-ligand 1 (PD-L1) in ≥1% of tumor cells (TC ≥1%) and who had not received prior systemic therapy received tislelizumab (400 mg IV Q6W) and lenvatinib (20 mg orally QD) until disease progression, start of new anticancer therapy, unacceptable toxicity, withdrawal of consent, or study termination; this cohort was closed early based on emerging external data. |
| OG003 | Gastric Cancer (GC) | Participants with advanced GC who had received one prior line of systemic therapy were enrolled to receive tislelizumab and lenvatinib at the RP2D (tislelizumab 400 mg IV Q6W; lenvatinib 20 mg orally QD) until disease progression, start of new anticancer therapy, unacceptable toxicity, withdrawal of consent, or study termination; this cohort was closed early due to changes in the first-line standard of care. |
|
|
Participants with NSCLC expressing programmed cell death-ligand 1 (PD-L1) in ≥1% of tumor cells (TC ≥1%) and who had not received prior systemic therapy received tislelizumab (400 mg IV Q6W) and lenvatinib (20 mg orally QD) until disease progression, start of new anticancer therapy, unacceptable toxicity, withdrawal of consent, or study termination; this cohort was closed early based on emerging external data. |
| OG003 | Gastric Cancer (GC) | Participants with advanced GC who had received one prior line of systemic therapy were enrolled to receive tislelizumab and lenvatinib at the RP2D (tislelizumab 400 mg IV Q6W; lenvatinib 20 mg orally QD) until disease progression, start of new anticancer therapy, unacceptable toxicity, withdrawal of consent, or study termination; this cohort was closed early due to changes in the first-line standard of care. |
|
|
| OG002 | Non-Small Cell Lung Cancer (NSCLC) | Participants with advanced GC who had received one prior line of systemic therapy were enrolled to receive tislelizumab and lenvatinib at the RP2D (tislelizumab 400 mg IV Q6W; lenvatinib 20 mg orally QD) until disease progression, start of new anticancer therapy, unacceptable toxicity, withdrawal of consent, or study termination; this cohort was closed early due to changes in the first-line standard of care. |
| OG003 | Gastric Cancer (GC) | Participants with cisplatin ineligible, systemic therapy naive advanced UC, were recruited to be treated with tislelizumab (400 mg IV Q6W) and lenvatinib (20 mg orally QD). This cohort was closed prior to any participant enrollment based on emerging external data. |
|
|
Systemic therapy naive participants with advanced or metastatic RCC received tislelizumab (400 mg IV Q6W) plus lenvatinib (20 mg orally QD) until disease progression, start of new anticancer therapy, unacceptable toxicity, withdrawal of consent, or study termination. |
| OG002 | Non-Small Cell Lung Cancer (NSCLC) | Participants with NSCLC expressing programmed cell death-ligand 1 (PD-L1) in ≥1% of tumor cells (TC ≥1%) and who had not received prior systemic therapy received tislelizumab (400 mg IV Q6W) and lenvatinib (20 mg orally QD) until disease progression, start of new anticancer therapy, unacceptable toxicity, withdrawal of consent, or study termination; this cohort was closed early based on emerging external data. |
| OG003 | Gastric Cancer (GC) | Participants with advanced GC who had received one prior line of systemic therapy were enrolled to receive tislelizumab and lenvatinib at the RP2D (tislelizumab 400 mg IV Q6W; lenvatinib 20 mg orally QD) until disease progression, start of new anticancer therapy, unacceptable toxicity, withdrawal of consent, or study termination; this cohort was closed early due to changes in the first-line standard of care. |
|
|
| OG002 | Non-Small Cell Lung Cancer (NSCLC) | Participants with NSCLC expressing programmed cell death-ligand 1 (PD-L1) in ≥1% of tumor cells (TC ≥1%) and who had not received prior systemic therapy received tislelizumab (400 mg IV Q6W) and lenvatinib (20 mg orally QD) until disease progression, start of new anticancer therapy, unacceptable toxicity, withdrawal of consent, or study termination; this cohort was closed early based on emerging external data. |
| OG003 | Gastric Cancer (GC) | Participants with advanced GC who had received one prior line of systemic therapy were enrolled to receive tislelizumab and lenvatinib at the RP2D (tislelizumab 400 mg IV Q6W; lenvatinib 20 mg orally QD) until disease progression, start of new anticancer therapy, unacceptable toxicity, withdrawal of consent, or study termination; this cohort was closed early due to changes in the first-line standard of care. |
|
|
| OG003 | Gastric Cancer (GC) | Participants with advanced GC who had received one prior line of systemic therapy were enrolled to receive tislelizumab and lenvatinib at the RP2D (tislelizumab 400 mg IV Q6W; lenvatinib 20 mg orally QD); this cohort was closed early due to changes in the first-line standard of care. |
|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|