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| ID | Type | Description | Link |
|---|---|---|---|
| CTR20211531 | Other Identifier | ChinaDrugTrials | |
| BGB-A317-A1217-204 | Other Identifier | BeiGene ID |
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This phase 2 trial examined whether the preliminary efficacy and safety of ociperlimab, tislelizumab, and cCRT when used in combination is expected to advance treatment options in the serious unmet medical need population of Limited-Stage Small Cell Lung Cancer (LS-SCLC) participants .
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A: Ociperlimab + Tislelizumab | Experimental | Ociperlimab plus tislelizumab combined with cCRT (at the investigator's discretion) for 4 cycles (each cycle is 28 days), followed by ociperlimab plus tislelizumab |
|
| Arm B: Tislelizumab | Experimental | Tislelizumab combined with cCRT (at the investigator's discretion) for 4 cycles, followed by tislelizumab alone |
|
| Arm C: Concurrent Chemoradiotherapy (cCRT) | Experimental | cCRT only for 4 cycles at the investigator's discretion |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ociperlimab | Drug | Ociperlimab 900 milligrams (mg) administered intravenously once every 3 weeks on Day 1 of each cycle |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression Free Survival (PFS) | Defined as the time from the date of randomization to the date of the first documented disease progression as determined by the investigator per RECIST v1.1 or death from any cause (whichever occurs first) | Up to approximately 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Complete Response Rate (CR) | defined as the percentage of participants who had CR as assessed by the investigator per RECIST v1.1 | Up to approximately 2 years |
| Overall Response Rate (ORR) | defined as the percentage of participants who had CR or partial response (PR) as assessed by the investigator per RECIST v1.1 |
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Key Inclusion Criteria:
Key Exclusion Criteria:
Note: Other protocol-defined Inclusion/Exclusion criteria may apply
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| Name | Affiliation | Role |
|---|---|---|
| BeiGene | Study Director | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tennessee Cancer Specialist | Knoxville | Tennessee | 37909 | United States | ||
| Peking University First Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | Youling Gong, Qingsong Pang, Rong Yu, Zhengfei Zhu, Jiangqiong Huang, Yufeng Cheng, Diansheng Zhong, Hongbo Wu, Seung Soo Yoo, Tracy Dobbs, Zinan Bao, Yunxia Zuo, Boxian Wei, Pu Sun, You Lu; Abstract CT255: AdvanTIG-204: A phase 2, multicenter, randomized, 3-arm, open-label study investigating the preliminary efficacy and safety of ociperlimab (anti-TIGIT) + tislelizumab (anti-PD-1) + concurrent chemoradiotherapy (cCRT) in patients with untreated limited-stage small cell lung cancer (SCLC). Cancer Res 1 April 2024; 84 (7_Supplement): CT255. https://doi.org/10.1158/1538-7445.AM2024-CT255 |
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Participants were enrolled in multiple study centers in China, South Korea, and the United States.
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| ID | Title | Description |
|---|---|---|
| FG000 | Arm A: Ociperlimab + Tislelizumab | Ociperlimab plus tislelizumab combined with cCRT (at the investigator's discretion) for 4 cycles (each cycle is 28 days), followed by ociperlimab plus tislelizumab Ociperlimab: Ociperlimab 900 milligrams (mg) administered intravenously once every 3 weeks on Day 1 of each cycle Tislelizumab: Tislelizumab 200 mg administered intravenously once every 3 weeks on Day 1 of each cycle Concurrent Chemoradiotherapy: Cisplatin/Carboplatin: Either cisplatin 75 milligrams/meters squared (mg/m2) administered intravenously once every 3 weeks on Day 1 of each cycle for 4 cycles or carboplatin at a dose of area under the curve (AUC) 5 administered intravenously once every 3 weeks on Day 1 of each cycle for 4 cycles. Etoposide: (100 mg/m2) administered intravenously on Days 1, 2, and 3 of each cycle for 4 cycles Thoracic radiation therapy (TRT): once daily fractions for 6 to 7 weeks for a total dose of 60 to 70 units of absorbed dose of ionizing radiation (Gy) |
| 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 | Oct 8, 2021 | Jul 16, 2024 |
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| Tislelizumab | Drug | Tislelizumab 200 mg administered intravenously once every 3 weeks on Day 1 of each cycle |
|
|
| Concurrent Chemoradiotherapy | Drug | Cisplatin/Carboplatin: Either cisplatin 75 milligrams/meters squared (mg/m2) administered intravenously once every 3 weeks on Day 1 of each cycle for 4 cycles or carboplatin at a dose of area under the curve (AUC) 5 administered intravenously once every 3 weeks on Day 1 of each cycle for 4 cycles. Etoposide: (100 mg/m2) administered intravenously on Days 1, 2, and 3 of each cycle for 4 cycles Thoracic radiation therapy (TRT): once daily fractions for 6 to 7 weeks for a total dose of 60 to 70 units of absorbed dose of ionizing radiation (Gy) |
|
| Up to approximately 2 years |
| Overall Response Rate (ORR) in the Programmed Death-Ligand 1 (PD-L1) Analysis Set | defined as the percentage of participants who had CR or partial response (PR) as assessed by the investigator per RECIST v1.1 | Up to approximately 2 years |
| Overall Response Rate (ORR) in the T Cell Immunoreceptor With Immunoglobulin and ITIM Domain (TIGIT) Analysis Set | defined as the percentage of participants who had CR or partial response (PR) as assessed by the investigator per RECIST v1.1 | Up to approximately 2 years |
| Duration of Response (DOR) | defined as the time from the date of the first occurrence of a documented objective response to the date of documented disease progression as assessed by the investigator per RECIST v1.1 or death from any cause (whichever occurs first) | Up to approximately 2 years |
| Overall Survival (OS) in the ITT Analysis Set | Defined as the time from the date of randomization to the date of death due to any cause | Up to approximately 2 years |
| Overall Survival (OS) in the PD-L1 Analysis Set | defined as the time from the date of randomization to the date of death due to any cause | Up to approximately 2 years |
| Overall Survival (OS) in the TIGIT Analysis Set | defined as the time from the date of randomization to the date of death due to any cause | Up to approximately 2 years |
| Distant Metastasis-free Survival (DMFS) | defined as the time from the date of randomization to the date of the first documented distant metastasis as assessed by the investigator per RECIST v1.1 or death from any cause (whichever occurs first) | Up to approximately 2 years |
| PFS in the PD-L1 Analysis Set | defined as the time from the date of randomization to the date of the first documented disease progression as determined by the investigator per RECIST v1.1 or death from any cause (whichever occurs first), | Up to approximately 2 years |
| PFS in the TIGIT Analysis Set | defined as the time from the date of randomization to the date of the first documented disease progression as determined by the investigator per RECIST v1.1 or death from any cause (whichever occurs first), | Up to approximately 2 years |
| Number of Participants Experiencing Adverse Events (AEs) | Number of participants with treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), v4.03 | From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years |
| Beijing |
| Beijing Municipality |
| 100034 |
| China |
| Beijing Cancer Hospital | Beijing | Beijing Municipality | 100142 | China |
| Gansu Provincial Cancer Hospital | Lanzhou | Gansu | 730050 | China |
| The First Affiliated Hospital, Sun Yat Sen University | Guangzhou | Guangdong | 510080 | China |
| The Tumor Hospital Affiliated to Guangxi Medical University | Nanning | Guangxi | 530021 | 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 |
| The Second Xiangya Hospital of Central South University | Changsha | Hunan | 410011 | China |
| Hunan Cancer Hospital | Changsha | Hunan | 410013 | China |
| Huai An First Peoples Hospital | Huaian | Jiangsu | 223300 | China |
| Nanjing Chest Hospital | Nanjing | Jiangsu | 210029 | China |
| The Affiliated Hospital of Xuzhou Medical University | Xuzhou | Jiangsu | 221000 | China |
| Hanzhong Central Hospital | Hanzhong | Shaanxi | 72300 | China |
| Qilu Hospital of Shandong University | Jinan | Shandong | 250000 | China |
| Linyi Cancer Hospital | Linyi | Shandong | 276001 | China |
| Qingdao Central Hospital | Qingdao | Shandong | 266031 | China |
| Yantai Yuhuangding Hospital | Yantai | Shandong | 264000 | China |
| Fudan University Shanghai Cancer Center | Shanghai | Shanghai Municipality | 200000 | China |
| Affiliated Zhongshan Hospital of Fudan University | Shanghai | Shanghai Municipality | 200032 | China |
| West China Hospital, Sichuan University | Chengdu | Sichuan | 610041 | China |
| Affiliated Hospital of North Sichuan Medical College | Nanchong | Sichuan | 637000 | China |
| Tianjin Medical University General Hospital | Tianjin | Tianjin Municipality | 300052 | China |
| Tianjin Medical University Cancer Institute and Hospital | Tianjin | Tianjin Municipality | 300060 | China |
| The Second Affiliated Hospital of Kunming Medical University | Kunming | Yunnan | 650000 | China |
| Zhejiang Cancer Hospital | Hangzhou | Zhejiang | 310022 | China |
| Hwa Mei Hospital, University of Chinese Academy of Sciences (Ningbo No Hospital) | Ningbo | Zhejiang | 315000 | China |
| Chungbuk National University Hospital | Cheongju-si | Chungcheongbukdo | 28644 | South Korea |
| Cha Bundang Medical Center, Cha University | Gyeonggido | Gyeonggi-do | 13496 | South Korea |
| The Catholic University of Korea, St Vincents Hospital | Suwon | Gyeonggi-do | 16247 | South Korea |
| Ajou University Hospital | Suwon | Gyeonggi-do | 16499 | South Korea |
| Kyungpook National University Chilgok Hospital | Daegu | Gyeongsangbukdo | 41404 | South Korea |
| FG001 | Arm B: Tislelizumab | Tislelizumab combined with cCRT (at the investigator's discretion) for 4 cycles, followed by tislelizumab alone Tislelizumab: Tislelizumab 200 mg administered intravenously once every 3 weeks on Day 1 of each cycle Concurrent Chemoradiotherapy: Cisplatin/Carboplatin: Either cisplatin 75 milligrams/meters squared (mg/m2) administered intravenously once every 3 weeks on Day 1 of each cycle for 4 cycles or carboplatin at a dose of area under the curve (AUC) 5 administered intravenously once every 3 weeks on Day 1 of each cycle for 4 cycles. Etoposide: (100 mg/m2) administered intravenously on Days 1, 2, and 3 of each cycle for 4 cycles Thoracic radiation therapy (TRT): once daily fractions for 6 to 7 weeks for a total dose of 60 to 70 units of absorbed dose of ionizing radiation (Gy) |
| FG002 | Arm C: Concurrent Chemoradiotherapy (cCRT) | cCRT only for 4 cycles at the investigator's discretion Concurrent Chemoradiotherapy: Cisplatin/Carboplatin: Either cisplatin 75 milligrams/meters squared (mg/m2) administered intravenously once every 3 weeks on Day 1 of each cycle for 4 cycles or carboplatin at a dose of area under the curve (AUC) 5 administered intravenously once every 3 weeks on Day 1 of each cycle for 4 cycles. Etoposide: (100 mg/m2) administered intravenously on Days 1, 2, and 3 of each cycle for 4 cycles Thoracic radiation therapy (TRT): once daily fractions for 6 to 7 weeks for a total dose of 60 to 70 units of absorbed dose of ionizing radiation (Gy) |
| COMPLETED |
|
| NOT COMPLETED |
|
|
The Intent-To-Treat (ITT) Analysis Set includes all randomized patients.
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| ID | Title | Description |
|---|---|---|
| BG000 | Arm A: Ociperlimab + Tislelizumab | Ociperlimab plus tislelizumab combined with cCRT (at the investigator's discretion) for 4 cycles (each cycle is 28 days), followed by ociperlimab plus tislelizumab Ociperlimab: Ociperlimab 900 milligrams (mg) administered intravenously once every 3 weeks on Day 1 of each cycle Tislelizumab: Tislelizumab 200 mg administered intravenously once every 3 weeks on Day 1 of each cycle Concurrent Chemoradiotherapy: Cisplatin/Carboplatin: Either cisplatin 75 milligrams/meters squared (mg/m2) administered intravenously once every 3 weeks on Day 1 of each cycle for 4 cycles or carboplatin at a dose of area under the curve (AUC) 5 administered intravenously once every 3 weeks on Day 1 of each cycle for 4 cycles. Etoposide: (100 mg/m2) administered intravenously on Days 1, 2, and 3 of each cycle for 4 cycles Thoracic radiation therapy (TRT): once daily fractions for 6 to 7 weeks for a total dose of 60 to 70 units of absorbed dose of ionizing radiation (Gy) |
| BG001 | Arm B: Tislelizumab | Tislelizumab combined with cCRT (at the investigator's discretion) for 4 cycles, followed by tislelizumab alone Tislelizumab: Tislelizumab 200 mg administered intravenously once every 3 weeks on Day 1 of each cycle Concurrent Chemoradiotherapy: Cisplatin/Carboplatin: Either cisplatin 75 milligrams/meters squared (mg/m2) administered intravenously once every 3 weeks on Day 1 of each cycle for 4 cycles or carboplatin at a dose of area under the curve (AUC) 5 administered intravenously once every 3 weeks on Day 1 of each cycle for 4 cycles. Etoposide: (100 mg/m2) administered intravenously on Days 1, 2, and 3 of each cycle for 4 cycles Thoracic radiation therapy (TRT): once daily fractions for 6 to 7 weeks for a total dose of 60 to 70 units of absorbed dose of ionizing radiation (Gy) |
| BG002 | Arm C: Concurrent Chemoradiotherapy (cCRT) | cCRT only for 4 cycles at the investigator's discretion Concurrent Chemoradiotherapy: Cisplatin/Carboplatin: Either cisplatin 75 milligrams/meters squared (mg/m2) administered intravenously once every 3 weeks on Day 1 of each cycle for 4 cycles or carboplatin at a dose of area under the curve (AUC) 5 administered intravenously once every 3 weeks on Day 1 of each cycle for 4 cycles. Etoposide: (100 mg/m2) administered intravenously on Days 1, 2, and 3 of each cycle for 4 cycles Thoracic radiation therapy (TRT): once daily fractions for 6 to 7 weeks for a total dose of 60 to 70 units of absorbed dose of ionizing radiation (Gy) |
| BG003 | 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 |
| ||||||||||||||||
| Race/Ethnicity, Customized | 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 | Progression Free Survival (PFS) | Defined as the time from the date of randomization to the date of the first documented disease progression as determined by the investigator per RECIST v1.1 or death from any cause (whichever occurs first) | The ITT analysis set includes all randomized participants | Posted | Median | 95% Confidence Interval | Months | Up to approximately 2 years |
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| |||||||||||||||||||||||||||||||
| Secondary | Complete Response Rate (CR) | defined as the percentage of participants who had CR as assessed by the investigator per RECIST v1.1 | The Intent-To-Treat (ITT) analysis set includes all randomized participants | Posted | Number | 95% Confidence Interval | percentage of participants | Up to approximately 2 years |
| |||||||||||||||||||||||||||||||||
| Secondary | Overall Response Rate (ORR) | defined as the percentage of participants who had CR or partial response (PR) as assessed by the investigator per RECIST v1.1 | The Intent-To-Treat (ITT) analysis set includes all randomized participants | Posted | Number | 95% Confidence Interval | percentage of participants | Up to approximately 2 years |
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| Secondary | Overall Response Rate (ORR) in the Programmed Death-Ligand 1 (PD-L1) Analysis Set | defined as the percentage of participants who had CR or partial response (PR) as assessed by the investigator per RECIST v1.1 | The PD-L1 Analysis Set includes all patients who have at least 1 evaluable PD-L1 measurement expressed by Tumor Area Percentage (TAP). | Posted | Number | 95% Confidence Interval | percentage of participants | Up to approximately 2 years |
| |||||||||||||||||||||||||||||||||
| Secondary | Overall Response Rate (ORR) in the T Cell Immunoreceptor With Immunoglobulin and ITIM Domain (TIGIT) Analysis Set | defined as the percentage of participants who had CR or partial response (PR) as assessed by the investigator per RECIST v1.1 | The TIGIT Analysis Set includes all patients who have at least 1 evaluable TIGIT measurement expressed by Immune Cells (IC) percentage. | Posted | Number | 95% Confidence Interval | percentage of participants | Up to approximately 2 years |
| |||||||||||||||||||||||||||||||||
| Secondary | Duration of Response (DOR) | defined as the time from the date of the first occurrence of a documented objective response to the date of documented disease progression as assessed by the investigator per RECIST v1.1 or death from any cause (whichever occurs first) | The ITT analysis set included all randomized participants; only participants with an objective response (CR or PR) were included in this analysis | Posted | Median | 95% Confidence Interval | Months | Up to approximately 2 years |
| |||||||||||||||||||||||||||||||||
| Secondary | Overall Survival (OS) in the ITT Analysis Set | Defined as the time from the date of randomization to the date of death due to any cause | The Intent-To-Treat (ITT) analysis set includes all randomized participants | Posted | Median | 95% Confidence Interval | months | Up to approximately 2 years |
| |||||||||||||||||||||||||||||||||
| Secondary | Overall Survival (OS) in the PD-L1 Analysis Set | defined as the time from the date of randomization to the date of death due to any cause | The PD-L1 Analysis Set includes all patients who have at least 1 evaluable PD-L1 measurement expressed by Tumor Area Percentage (TAP). | Posted | Median | 95% Confidence Interval | months | Up to approximately 2 years |
| |||||||||||||||||||||||||||||||||
| Secondary | Overall Survival (OS) in the TIGIT Analysis Set | defined as the time from the date of randomization to the date of death due to any cause | The TIGIT Analysis Set includes all patients who have at least 1 evaluable TIGIT measurement expressed by immune cells percentage. | Posted | Median | 95% Confidence Interval | months | Up to approximately 2 years |
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| Secondary | Distant Metastasis-free Survival (DMFS) | defined as the time from the date of randomization to the date of the first documented distant metastasis as assessed by the investigator per RECIST v1.1 or death from any cause (whichever occurs first) | The Intent-To-Treat (ITT) analysis set includes all randomized participants | Posted | Median | 95% Confidence Interval | months | Up to approximately 2 years |
| |||||||||||||||||||||||||||||||||
| Secondary | PFS in the PD-L1 Analysis Set | defined as the time from the date of randomization to the date of the first documented disease progression as determined by the investigator per RECIST v1.1 or death from any cause (whichever occurs first), | The PD-L1 Analysis Set includes all patients who have at least 1 evaluable PD-L1 measurement expressed by Tumor Area Percentage (TAP). | Posted | Median | 95% Confidence Interval | months | Up to approximately 2 years |
| |||||||||||||||||||||||||||||||||
| Secondary | PFS in the TIGIT Analysis Set | defined as the time from the date of randomization to the date of the first documented disease progression as determined by the investigator per RECIST v1.1 or death from any cause (whichever occurs first), | The TIGIT Analysis Set includes all patients who have at least 1 evaluable TIGIT measurement expressed by immune cells percentage. | Posted | Median | 95% Confidence Interval | months | Up to approximately 2 years |
| |||||||||||||||||||||||||||||||||
| Secondary | Number of Participants Experiencing Adverse Events (AEs) | Number of participants with treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), v4.03 | The Safety Analysis Set includes all patients who have received >= 1 dose of any component of study drug. | Posted | Count of Participants | Participants | From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years |
|
All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
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 AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
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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 | Arm A: Ociperlimab + Tislelizumab | Ociperlimab plus tislelizumab combined with cCRT (at the investigator's discretion) for 4 cycles (each cycle is 28 days), followed by ociperlimab plus tislelizumab | 12 | 41 | 25 | 41 | 41 | 41 |
| EG001 | Arm B: Tislelizumab | Tislelizumab combined with cCRT (at the investigator's discretion) for 4 cycles, followed by tislelizumab alone | 13 | 42 | 20 | 42 | 42 | 42 |
| EG002 | Arm C: Concurrent Chemoradiotherapy (cCRT) | cCRT only for 4 cycles at the investigator's discretion | 14 | 43 | 12 | 43 | 43 | 43 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | meddra 26.0 | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | meddra 26.0 | Systematic Assessment |
| |
| Arteriosclerosis coronary artery | Cardiac disorders | meddra 26.0 | Systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | meddra 26.0 | Systematic Assessment |
| |
| Immune-mediated enterocolitis | Gastrointestinal disorders | meddra 26.0 | Systematic Assessment |
| |
| Oesophageal fistula | Gastrointestinal disorders | meddra 26.0 | Systematic Assessment |
| |
| Oesophageal perforation | Gastrointestinal disorders | meddra 26.0 | Systematic Assessment |
| |
| Pancreatitis | Gastrointestinal disorders | meddra 26.0 | Systematic Assessment |
| |
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | meddra 26.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | meddra 26.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | meddra 26.0 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | meddra 26.0 | Systematic Assessment |
| |
| COVID-19 pneumonia | Infections and infestations | meddra 26.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | meddra 26.0 | Systematic Assessment |
| |
| Pneumonia bacterial | Infections and infestations | meddra 26.0 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | meddra 26.0 | Systematic Assessment |
| |
| Septic shock | Infections and infestations | meddra 26.0 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | meddra 26.0 | Systematic Assessment |
| |
| Foreign body in gastrointestinal tract | Injury, poisoning and procedural complications | meddra 26.0 | Systematic Assessment |
| |
| Radiation oesophagitis | Injury, poisoning and procedural complications | meddra 26.0 | Systematic Assessment |
| |
| Radiation pneumonitis | Injury, poisoning and procedural complications | meddra 26.0 | Systematic Assessment |
| |
| Lymphocyte count decreased | Investigations | meddra 26.0 | Systematic Assessment |
| |
| Myocardial necrosis marker increased | Investigations | meddra 26.0 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | meddra 26.0 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | meddra 26.0 | Systematic Assessment |
| |
| White blood cell count decreased | Investigations | 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 |
| |
| Back pain | Musculoskeletal and connective tissue disorders | meddra 26.0 | Systematic Assessment |
| |
| Rotator cuff syndrome | Musculoskeletal and connective tissue disorders | meddra 26.0 | Systematic Assessment |
| |
| Ataxia | Nervous system disorders | meddra 26.0 | Systematic Assessment |
| |
| Immune-mediated optic neuritis | Nervous system 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 |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | meddra 26.0 | Systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | meddra 26.0 | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal 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 |
| |
| Leukopenia | 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 |
| |
| Sinus tachycardia | Cardiac disorders | meddra 26.0 | Systematic Assessment |
| |
| Supraventricular tachycardia | Cardiac disorders | meddra 26.0 | Systematic Assessment |
| |
| Hyperthyroidism | Endocrine disorders | meddra 26.0 | Systematic Assessment |
| |
| Hypothyroidism | Endocrine 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 |
| |
| Constipation | Gastrointestinal disorders | meddra 26.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | meddra 26.0 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | meddra 26.0 | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | meddra 26.0 | Systematic Assessment |
| |
| Eructation | Gastrointestinal disorders | meddra 26.0 | Systematic Assessment |
| |
| Gastric dilatation | 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 |
| |
| Nausea | Gastrointestinal disorders | meddra 26.0 | Systematic Assessment |
| |
| Reflux gastritis | 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 |
| |
| Chest pain | General disorders | meddra 26.0 | Systematic Assessment |
| |
| Fatigue | General disorders | meddra 26.0 | Systematic Assessment |
| |
| Malaise | General disorders | meddra 26.0 | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | meddra 26.0 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | meddra 26.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | meddra 26.0 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | meddra 26.0 | Systematic Assessment |
| |
| Influenza | Infections and infestations | meddra 26.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | meddra 26.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | meddra 26.0 | Systematic Assessment |
| |
| Radiation oesophagitis | Injury, poisoning and procedural complications | meddra 26.0 | Systematic Assessment |
| |
| Radiation pneumonitis | Injury, poisoning and procedural complications | meddra 26.0 | Systematic Assessment |
| |
| Radiation skin injury | Injury, poisoning and procedural complications | meddra 26.0 | Systematic Assessment |
| |
| Tracheal radiation injury | 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 |
| |
| Blood bilirubin 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 fibrinogen increased | Investigations | meddra 26.0 | Systematic Assessment |
| |
| Blood thyroid stimulating hormone decreased | Investigations | meddra 26.0 | Systematic Assessment |
| |
| Blood urea increased | Investigations | meddra 26.0 | Systematic Assessment |
| |
| C-reactive protein increased | Investigations | meddra 26.0 | Systematic Assessment |
| |
| Fibrin D dimer increased | Investigations | meddra 26.0 | Systematic Assessment |
| |
| Gamma-glutamyltransferase increased | Investigations | meddra 26.0 | Systematic Assessment |
| |
| Lymphocyte count decreased | Investigations | meddra 26.0 | Systematic Assessment |
| |
| Monocyte 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 |
| |
| Red blood cell count decreased | Investigations | meddra 26.0 | Systematic Assessment |
| |
| SARS-CoV-2 test positive | 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 |
| |
| Decreased appetite | Metabolism and nutrition disorders | meddra 26.0 | Systematic Assessment |
| |
| Hypercholesterolaemia | Metabolism and nutrition disorders | meddra 26.0 | Systematic Assessment |
| |
| Hyperglycaemia | 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 |
| |
| Hypomagnesaemia | 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 |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | meddra 26.0 | Systematic Assessment |
| |
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | meddra 26.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | meddra 26.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | meddra 26.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | meddra 26.0 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | meddra 26.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | meddra 26.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | meddra 26.0 | Systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | meddra 26.0 | Systematic Assessment |
| |
| Hiccups | Respiratory, thoracic and mediastinal disorders | meddra 26.0 | Systematic Assessment |
| |
| Laryngeal pain | Respiratory, thoracic and mediastinal disorders | meddra 26.0 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | meddra 26.0 | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | meddra 26.0 | Systematic Assessment |
| |
| Productive cough | Respiratory, thoracic and mediastinal disorders | meddra 26.0 | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | meddra 26.0 | Systematic Assessment |
| |
| Eczema | Skin and subcutaneous tissue disorders | meddra 26.0 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | meddra 26.0 | Systematic Assessment |
| |
| Rash | 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 | Aug 22, 2023 | Jul 16, 2024 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| C000707970 | tislelizumab |
| D059248 | Chemoradiotherapy |
| ID | Term |
|---|---|
| D003131 | Combined Modality Therapy |
| D013812 | Therapeutics |
| D004358 | Drug Therapy |
| D011878 | Radiotherapy |
Not provided
Not provided
| Male |
|
| White |
|
| OG002 | Arm C: Concurrent Chemoradiotherapy (cCRT) | cCRT only for 4 cycles at the investigator's discretion Concurrent Chemoradiotherapy: Cisplatin/Carboplatin: Either cisplatin 75 milligrams/meters squared (mg/m2) administered intravenously once every 3 weeks on Day 1 of each cycle for 4 cycles or carboplatin at a dose of area under the curve (AUC) 5 administered intravenously once every 3 weeks on Day 1 of each cycle for 4 cycles. Etoposide: (100 mg/m2) administered intravenously on Days 1, 2, and 3 of each cycle for 4 cycles Thoracic radiation therapy (TRT): once daily fractions for 6 to 7 weeks for a total dose of 60 to 70 units of absorbed dose of ionizing radiation (Gy) |
|
|
| OG002 | Arm C: Concurrent Chemoradiotherapy (cCRT) | cCRT only for 4 cycles at the investigator's discretion Concurrent Chemoradiotherapy: Cisplatin/Carboplatin: Either cisplatin 75 milligrams/meters squared (mg/m2) administered intravenously once every 3 weeks on Day 1 of each cycle for 4 cycles or carboplatin at a dose of area under the curve (AUC) 5 administered intravenously once every 3 weeks on Day 1 of each cycle for 4 cycles. Etoposide: (100 mg/m2) administered intravenously on Days 1, 2, and 3 of each cycle for 4 cycles Thoracic radiation therapy (TRT): once daily fractions for 6 to 7 weeks for a total dose of 60 to 70 units of absorbed dose of ionizing radiation (Gy) |
|
|
Tislelizumab combined with cCRT (at the investigator's discretion) for 4 cycles, followed by tislelizumab alone
Tislelizumab: Tislelizumab 200 mg administered intravenously once every 3 weeks on Day 1 of each cycle
Concurrent Chemoradiotherapy: Cisplatin/Carboplatin: Either cisplatin 75 milligrams/meters squared (mg/m2) administered intravenously once every 3 weeks on Day 1 of each cycle for 4 cycles or carboplatin at a dose of area under the curve (AUC) 5 administered intravenously once every 3 weeks on Day 1 of each cycle for 4 cycles.
Etoposide: (100 mg/m2) administered intravenously on Days 1, 2, and 3 of each cycle for 4 cycles
Thoracic radiation therapy (TRT): once daily fractions for 6 to 7 weeks for a total dose of 60 to 70 units of absorbed dose of ionizing radiation (Gy)
| OG002 | Arm C: Concurrent Chemoradiotherapy (cCRT) | cCRT only for 4 cycles at the investigator's discretion Concurrent Chemoradiotherapy: Cisplatin/Carboplatin: Either cisplatin 75 milligrams/meters squared (mg/m2) administered intravenously once every 3 weeks on Day 1 of each cycle for 4 cycles or carboplatin at a dose of area under the curve (AUC) 5 administered intravenously once every 3 weeks on Day 1 of each cycle for 4 cycles. Etoposide: (100 mg/m2) administered intravenously on Days 1, 2, and 3 of each cycle for 4 cycles Thoracic radiation therapy (TRT): once daily fractions for 6 to 7 weeks for a total dose of 60 to 70 units of absorbed dose of ionizing radiation (Gy) |
|
|
Tislelizumab combined with cCRT (at the investigator's discretion) for 4 cycles, followed by tislelizumab alone Tislelizumab: Tislelizumab 200 mg administered intravenously once every 3 weeks on Day 1 of each cycle Concurrent Chemoradiotherapy: Cisplatin/Carboplatin: Either cisplatin 75 milligrams/meters squared (mg/m2) administered intravenously once every 3 weeks on Day 1 of each cycle for 4 cycles or carboplatin at a dose of area under the curve (AUC) 5 administered intravenously once every 3 weeks on Day 1 of each cycle for 4 cycles. Etoposide: (100 mg/m2) administered intravenously on Days 1, 2, and 3 of each cycle for 4 cycles Thoracic radiation therapy (TRT): once daily fractions for 6 to 7 weeks for a total dose of 60 to 70 units of absorbed dose of ionizing radiation (Gy) |
| OG002 | Arm C: Concurrent Chemoradiotherapy (cCRT) | cCRT only for 4 cycles at the investigator's discretion Concurrent Chemoradiotherapy: Cisplatin/Carboplatin: Either cisplatin 75 milligrams/meters squared (mg/m2) administered intravenously once every 3 weeks on Day 1 of each cycle for 4 cycles or carboplatin at a dose of area under the curve (AUC) 5 administered intravenously once every 3 weeks on Day 1 of each cycle for 4 cycles. Etoposide: (100 mg/m2) administered intravenously on Days 1, 2, and 3 of each cycle for 4 cycles Thoracic radiation therapy (TRT): once daily fractions for 6 to 7 weeks for a total dose of 60 to 70 units of absorbed dose of ionizing radiation (Gy) |
|
|
Tislelizumab combined with cCRT (at the investigator's discretion) for 4 cycles, followed by tislelizumab alone Tislelizumab: Tislelizumab 200 mg administered intravenously once every 3 weeks on Day 1 of each cycle Concurrent Chemoradiotherapy: Cisplatin/Carboplatin: Either cisplatin 75 milligrams/meters squared (mg/m2) administered intravenously once every 3 weeks on Day 1 of each cycle for 4 cycles or carboplatin at a dose of area under the curve (AUC) 5 administered intravenously once every 3 weeks on Day 1 of each cycle for 4 cycles. Etoposide: (100 mg/m2) administered intravenously on Days 1, 2, and 3 of each cycle for 4 cycles Thoracic radiation therapy (TRT): once daily fractions for 6 to 7 weeks for a total dose of 60 to 70 units of absorbed dose of ionizing radiation (Gy) |
| OG002 | Arm C: Concurrent Chemoradiotherapy (cCRT) | cCRT only for 4 cycles at the investigator's discretion Concurrent Chemoradiotherapy: Cisplatin/Carboplatin: Either cisplatin 75 milligrams/meters squared (mg/m2) administered intravenously once every 3 weeks on Day 1 of each cycle for 4 cycles or carboplatin at a dose of area under the curve (AUC) 5 administered intravenously once every 3 weeks on Day 1 of each cycle for 4 cycles. Etoposide: (100 mg/m2) administered intravenously on Days 1, 2, and 3 of each cycle for 4 cycles Thoracic radiation therapy (TRT): once daily fractions for 6 to 7 weeks for a total dose of 60 to 70 units of absorbed dose of ionizing radiation (Gy) |
|
|
| OG002 | Arm C: Concurrent Chemoradiotherapy (cCRT) | cCRT only for 4 cycles at the investigator's discretion Concurrent Chemoradiotherapy: Cisplatin/Carboplatin: Either cisplatin 75 milligrams/meters squared (mg/m2) administered intravenously once every 3 weeks on Day 1 of each cycle for 4 cycles or carboplatin at a dose of area under the curve (AUC) 5 administered intravenously once every 3 weeks on Day 1 of each cycle for 4 cycles. Etoposide: (100 mg/m2) administered intravenously on Days 1, 2, and 3 of each cycle for 4 cycles Thoracic radiation therapy (TRT): once daily fractions for 6 to 7 weeks for a total dose of 60 to 70 units of absorbed dose of ionizing radiation (Gy) |
|
|
| OG002 | Arm C: Concurrent Chemoradiotherapy (cCRT) | cCRT only for 4 cycles at the investigator's discretion Concurrent Chemoradiotherapy: Cisplatin/Carboplatin: Either cisplatin 75 milligrams/meters squared (mg/m2) administered intravenously once every 3 weeks on Day 1 of each cycle for 4 cycles or carboplatin at a dose of area under the curve (AUC) 5 administered intravenously once every 3 weeks on Day 1 of each cycle for 4 cycles. Etoposide: (100 mg/m2) administered intravenously on Days 1, 2, and 3 of each cycle for 4 cycles Thoracic radiation therapy (TRT): once daily fractions for 6 to 7 weeks for a total dose of 60 to 70 units of absorbed dose of ionizing radiation (Gy) |
|
|
| OG002 | Arm C: Concurrent Chemoradiotherapy (cCRT) | cCRT only for 4 cycles at the investigator's discretion Concurrent Chemoradiotherapy: Cisplatin/Carboplatin: Either cisplatin 75 milligrams/meters squared (mg/m2) administered intravenously once every 3 weeks on Day 1 of each cycle for 4 cycles or carboplatin at a dose of area under the curve (AUC) 5 administered intravenously once every 3 weeks on Day 1 of each cycle for 4 cycles. Etoposide: (100 mg/m2) administered intravenously on Days 1, 2, and 3 of each cycle for 4 cycles Thoracic radiation therapy (TRT): once daily fractions for 6 to 7 weeks for a total dose of 60 to 70 units of absorbed dose of ionizing radiation (Gy) |
|
|
| OG002 | Arm C: Concurrent Chemoradiotherapy (cCRT) | cCRT only for 4 cycles at the investigator's discretion Concurrent Chemoradiotherapy: Cisplatin/Carboplatin: Either cisplatin 75 milligrams/meters squared (mg/m2) administered intravenously once every 3 weeks on Day 1 of each cycle for 4 cycles or carboplatin at a dose of area under the curve (AUC) 5 administered intravenously once every 3 weeks on Day 1 of each cycle for 4 cycles. Etoposide: (100 mg/m2) administered intravenously on Days 1, 2, and 3 of each cycle for 4 cycles Thoracic radiation therapy (TRT): once daily fractions for 6 to 7 weeks for a total dose of 60 to 70 units of absorbed dose of ionizing radiation (Gy) |
|
|
Tislelizumab combined with cCRT (at the investigator's discretion) for 4 cycles, followed by tislelizumab alone
Tislelizumab: Tislelizumab 200 mg administered intravenously once every 3 weeks on Day 1 of each cycle
Concurrent Chemoradiotherapy: Cisplatin/Carboplatin: Either cisplatin 75 milligrams/meters squared (mg/m2) administered intravenously once every 3 weeks on Day 1 of each cycle for 4 cycles or carboplatin at a dose of area under the curve (AUC) 5 administered intravenously once every 3 weeks on Day 1 of each cycle for 4 cycles.
Etoposide: (100 mg/m2) administered intravenously on Days 1, 2, and 3 of each cycle for 4 cycles
Thoracic radiation therapy (TRT): once daily fractions for 6 to 7 weeks for a total dose of 60 to 70 units of absorbed dose of ionizing radiation (Gy)
| OG002 | Arm C: Concurrent Chemoradiotherapy (cCRT) | cCRT only for 4 cycles at the investigator's discretion Concurrent Chemoradiotherapy: Cisplatin/Carboplatin: Either cisplatin 75 milligrams/meters squared (mg/m2) administered intravenously once every 3 weeks on Day 1 of each cycle for 4 cycles or carboplatin at a dose of area under the curve (AUC) 5 administered intravenously once every 3 weeks on Day 1 of each cycle for 4 cycles. Etoposide: (100 mg/m2) administered intravenously on Days 1, 2, and 3 of each cycle for 4 cycles Thoracic radiation therapy (TRT): once daily fractions for 6 to 7 weeks for a total dose of 60 to 70 units of absorbed dose of ionizing radiation (Gy) |
|
|
Tislelizumab combined with cCRT (at the investigator's discretion) for 4 cycles, followed by tislelizumab alone
Tislelizumab: Tislelizumab 200 mg administered intravenously once every 3 weeks on Day 1 of each cycle
Concurrent Chemoradiotherapy: Cisplatin/Carboplatin: Either cisplatin 75 milligrams/meters squared (mg/m2) administered intravenously once every 3 weeks on Day 1 of each cycle for 4 cycles or carboplatin at a dose of area under the curve (AUC) 5 administered intravenously once every 3 weeks on Day 1 of each cycle for 4 cycles.
Etoposide: (100 mg/m2) administered intravenously on Days 1, 2, and 3 of each cycle for 4 cycles
Thoracic radiation therapy (TRT): once daily fractions for 6 to 7 weeks for a total dose of 60 to 70 units of absorbed dose of ionizing radiation (Gy)
| OG002 | Arm C: Concurrent Chemoradiotherapy (cCRT) | cCRT only for 4 cycles at the investigator's discretion Concurrent Chemoradiotherapy: Cisplatin/Carboplatin: Either cisplatin 75 milligrams/meters squared (mg/m2) administered intravenously once every 3 weeks on Day 1 of each cycle for 4 cycles or carboplatin at a dose of area under the curve (AUC) 5 administered intravenously once every 3 weeks on Day 1 of each cycle for 4 cycles. Etoposide: (100 mg/m2) administered intravenously on Days 1, 2, and 3 of each cycle for 4 cycles Thoracic radiation therapy (TRT): once daily fractions for 6 to 7 weeks for a total dose of 60 to 70 units of absorbed dose of ionizing radiation (Gy) |
|
|
| Arm B: Tislelizumab |
Tislelizumab combined with cCRT (at the investigator's discretion) for 4 cycles, followed by tislelizumab alone Tislelizumab: Tislelizumab 200 mg administered intravenously once every 3 weeks on Day 1 of each cycle Concurrent Chemoradiotherapy: Cisplatin/Carboplatin: Either cisplatin 75 milligrams/meters squared (mg/m2) administered intravenously once every 3 weeks on Day 1 of each cycle for 4 cycles or carboplatin at a dose of area under the curve (AUC) 5 administered intravenously once every 3 weeks on Day 1 of each cycle for 4 cycles. Etoposide: (100 mg/m2) administered intravenously on Days 1, 2, and 3 of each cycle for 4 cycles Thoracic radiation therapy (TRT): once daily fractions for 6 to 7 weeks for a total dose of 60 to 70 units of absorbed dose of ionizing radiation (Gy) |
| OG002 | Arm C: Concurrent Chemoradiotherapy (cCRT) | cCRT only for 4 cycles at the investigator's discretion Concurrent Chemoradiotherapy: Cisplatin/Carboplatin: Either cisplatin 75 milligrams/meters squared (mg/m2) administered intravenously once every 3 weeks on Day 1 of each cycle for 4 cycles or carboplatin at a dose of area under the curve (AUC) 5 administered intravenously once every 3 weeks on Day 1 of each cycle for 4 cycles. Etoposide: (100 mg/m2) administered intravenously on Days 1, 2, and 3 of each cycle for 4 cycles Thoracic radiation therapy (TRT): once daily fractions for 6 to 7 weeks for a total dose of 60 to 70 units of absorbed dose of ionizing radiation (Gy) |
|
|