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| ID | Type | Description | Link |
|---|---|---|---|
| 2018-000245-39 | EudraCT Number | ||
| CTR20171112 | Registry Identifier | ChinaDrugTrials |
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The purpose of this study is to show that tislelizumab will improve overall survival in participants with Stage IIIB or IV non-small cell lung cancer when compared to docetaxel in second or third-line treatment setting.
This is a randomized, open-label, multicenter Phase 3 study in adult participants with histologically confirmed, locally advanced or metastatic (Stage IIIB or IV), NSCLC (squamous or non-squamous) who have disease progression during or after a platinum-containing regimen.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tislelizumab | Experimental | Participants received tislelizumab 200 mg intravenously (IV) once every 3 weeks until disease progression, unacceptable toxicity, or withdrawal of informed consent, whichever occurred first. |
|
| Docetaxel | Active Comparator | Participants received docetaxel 75 mg/m² IV once every 3 weeks until disease progression, unacceptable toxicity, or withdrawal of informed consent, whichever occurred first. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tislelizumab | Drug | Tislelizumab administered by intravenous (IV) infusion |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS) in All Participants (Co-primary Endpoint) | OS was defined as the time from randomization to death from any cause. Median OS was calculated using the Kaplan-Meier method. Data for participants who were not reported as having died at the time of analysis were censored at the date they were last known to be alive. Data for participants who did not have postbaseline information were censored at the date of randomization. | From randomization to the data cutoff date of 10 August 2020; up to 32.4 months |
| Overall Survival (OS) in Programmed Cell Death Protein Ligand-1 (PD-L1)-Positive Participants (Co-primary Endpoint) | OS was defined as the time from randomization to death from any cause. Median OS was calculated using the Kaplan-Meier method. Data for participants who were not reported as having died at the time of analysis were censored at the date they were last known to be alive. Data for participants who did not have postbaseline information were censored at the date of randomization. | From randomization up to the final efficacy analysis data cut-off date of 15 July 2021; Up to 43 months |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) in All Participants | Objective response rate is defined as the percentage of participants who had a 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 included computed tomography (CT) scans or magnetic resonance imaging (MRI), with preference for CT, of the chest, abdomen, and pelvis. CR: 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: At least a 30% decrease in the size of target lesions and no progression of non-target lesions and no new lesions, or disappearance of all target lesions with persistence of one or more non-target lesion(s) and/or maintenance of tumor marker level above the normal limits and no new lesions. |
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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 |
|---|---|---|
| Caicun Zhou, PhD | Shanghai Pulmonary Hospital, Shanghai, China | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital de Amor Barretos | Barretos | 14784-400 | Brazil | |||
| Hospital Evangelico de Cachoeiro de Itapemirim |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36184068 | Result | Zhou C, Huang D, Fan Y, Yu X, Liu Y, Shu Y, Ma Z, Wang Z, Cheng Y, Wang J, Hu S, Liu Z, Poddubskaya E, Disel U, Akopov A, Dvorkin M, Zheng W, Ma Y, Wang Y, Li S, Yu C, Rivalland G. Tislelizumab Versus Docetaxel in Patients With Previously Treated Advanced NSCLC (RATIONALE-303): A Phase 3, Open-Label, Randomized Controlled Trial. J Thorac Oncol. 2023 Jan;18(1):93-105. doi: 10.1016/j.jtho.2022.09.217. Epub 2022 Sep 29. | |
| 37587845 |
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Eligible participants were randomized in a 2:1 ratio to receive either tislelizumab or docetaxel treatment. Randomization was stratified by histology (squamous versus non--squamous), line of therapy (second line versus third line), and programmed cell death protein ligand-1 (PD-L1) expression (≥ 25% tumor cells (TCs) versus < 25% TCs).
This study was conducted at 109 study centers in 10 countries (China, Brazil, Bulgaria, Lithuania, Mexico, New Zealand, Poland, Russia, Slovakia, and Turkey).
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| ID | Title | Description |
|---|---|---|
| FG000 | Tislelizumab | Participants received tislelizumab 200 mg intravenously (IV) once every 3 weeks until disease progression, unacceptable toxicity, or withdrawal of informed consent, whichever occurred first. |
| FG001 | Docetaxel |
| 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 | Mar 9, 2020 | Jan 15, 2025 |
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| Docetaxel | Drug | Docetaxel administered as an IV infusion over 1 hour |
|
| From randomization up to the final efficacy analysis data cut-off date of 15 July 2021; Up to 43 months |
| Objective Response Rate in PD-L1-Positive Participants | Objective response rate is defined as the percentage of participants who had a 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 included computed tomography (CT) scans or magnetic resonance imaging (MRI), with preference for CT, of the chest, abdomen, and pelvis. CR: 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: At least a 30% decrease in the size of target lesions and no progression of non-target lesions and no new lesions, or disappearance of all target lesions with persistence of one or more non-target lesion(s) and/or maintenance of tumor marker level above the normal limits and no new lesions. | From randomization up to the final efficacy analysis data cut-off date of 15 July 2021; Up to 43 months |
| Duration of Response (DOR) for All Responders | DoR was defined as the time from the first documented objective response to documented 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 (PD): At least a 20% increase in the size of target lesions with an absolute increase of at least 5 mm, or unequivocal progression of existing non-target lesions, or the appearance of any new lesions. | From randomization up to the final efficacy analysis data cut-off date of 15 July 2021; Up to 43 months |
| Duration of Response (DOR) in PD-L1-Positive Responders | DoR was defined as the time from the first documented objective response to documented 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 (PD): At least a 20% increase in the size of target lesions with an absolute increase of at least 5 mm, or unequivocal progression of existing non-target lesions, or the appearance of any new lesions. | From randomization up to the final efficacy analysis data cut-off date of 15 July 2021; Up to 43 months |
| Progression-free Survival (PFS) in All Participants | PFS was defined as the time from randomization to the first objectively documented disease progression as assessed by the investigator per RECIST v1.1 or death from any cause, whichever occurred first. Median PFS was estimated using the Kaplan-Meier method. | From randomization up to the final efficacy analysis data cut-off date of 15 July 2021; Up to 43 months |
| Progression-free Survival in PD-L1 Positive Participants | PFS was defined as the time from randomization to the first objectively documented disease progression as assessed by the investigator per RECIST v1.1 or death from any cause, whichever occurred first. Median PFS was estimated using the Kaplan-Meier method. | From randomization up to the final efficacy analysis data cut-off date of 15 July 2021; Up to 43 months |
| Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Global Health Status (GHS)/Quality of Life (QOL) Score | The EORTC QLQ-30 contains 30 questions that incorporate 5 functional scales (physical functioning, role functioning, emotional functioning, cognitive functioning, and social functioning), 1 global health status scale, 3 symptom scales (fatigue, nausea and vomiting, and pain), and 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). The participant answers questions about their health during the past week. There are 28 questions answered on a 4-point scale where 1 = Not at all (best) and 4 = Very Much (worst) and two global health quality of life (QOL) questions answered on a 7-point scale where 1 = Very poor and 7 = Excellent. Raw scores are transformed into a 0 to 100 scale via linear transformation. Higher scores in GHS/QoL score indicates better quality of life. | Baseline and Cycle 6 (each cycle was 3 weeks) |
| Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 Items (QLQ-LC13) Coughing, Dyspnoea, and Chest Pain Scores | The EORTC QLQ-LC13 is the lung cancer module of the QLQ-C30 and measures lung cancer-specific disease and treatment symptoms. It includes 13 questions about specific symptoms in which participants respond based on a 4-point scale, where 1 is "not at all" and 4 is "very much". Raw scores are transformed into a 0 to 100 scale via linear transformation. Lower scores indicate an improvement in symptoms. | Baseline and Cycle 6 (each cycle was 3 weeks) |
| Change From Baseline in European Quality of Life 5-Dimensions, 5-level (EQ-5D-5L) Visual Analogue Scale (VAS) | The EQ-5D-5L measures health outcomes using a VAS to record a participant's self-rated health on a scale from 0 to 100, where 100 is 'the best health you can imagine' and 0 is 'the worst health you can imagine.' A higher score indicates better health outcomes. | Baseline and Cycle 6 (each cycle was 3 weeks) |
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) | An adverse event is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study drug, whether considered related to study drug or not. The investigator assessed the severity of each AE and graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) v4.03 as defined below:
| From first dose of study drug to 30 days after last dose, up to the study completion date cut-off date of 18 January 2024 (up to approximately 63 months) |
| Cachoeiro de Itapemirim |
| 29308-020 |
| Brazil |
| Hospital Haroldo Juacaba Instituto Do Cancer Do Ceara | Fortaleza | 60430-230 | Brazil |
| Oncosite Centro de Pesquisa Clinica Em Oncologia | Ijuí | 98700-000 | Brazil |
| Fundacao Doutor Amaral Carvalho | Jaú | 17210-120 | Brazil |
| Hospital Bruno Born | Lajeado | 95900-000 | Brazil |
| Hospital Sao Vicente de Paulo | Passo Fundo | 99010-080 | Brazil |
| Hgb Hospital Giovanni Battista Mae de Deus Center | Porto Alegre | 90470-340 | Brazil |
| Hospital Sao Lucas Da Pucrs | Porto Alegre | 90610-000 | Brazil |
| Hospital Nossa Senhora Da Conceicao | Porto Alegre | 91350-200 | Brazil |
| Hospital de Clinicas de Porto Alegre | Porto AlegreRS | 900350-903 | Brazil |
| Inca Instituto Nacional de Cancer | Rio de Janeiro | 20231-050 | Brazil |
| Nob Nucleo de Oncologia Da Bahia | Salvador | 40170-110 | Brazil |
| Cepho Centro de Estudos E Pesquisas de Hematologia E Oncologia | Santo André | 09060-650 | Brazil |
| Fundacao Faculdade Regional de Medicina de Sao Jose Do Rio Preto | São José do Rio Preto | 15090-000 | Brazil |
| Icesp Instituto Do Cancer Do Estado de Sao Paulo Octavio Frias de Oliveira | São Paulo | 01246-000 | Brazil |
| Umhat Deva Maria, Eood | Burgas | 8000 | Bulgaria |
| Mhat Dobrich, Ad | Dobrich | 9300 | Bulgaria |
| Mhat Dr Tota Venkova, Ad | Gabrovo | 5300 | Bulgaria |
| Complex Oncology Center Rousse Eood | Rousse | 7000 | Bulgaria |
| Mhat For Womens Health Nadezhda, Ood | Sofia | 1330 | Bulgaria |
| Acibadem City Clinic Mhat Tokuda Ead | Sofia | 1407 | Bulgaria |
| Anhui Provincial Hospital | Hefei | Anhui | 230000 | China |
| The First Affiliated Hospital of Anhui Medical University | Hefei | Anhui | 230000 | China |
| Cancer Hospital Chinese Academy of Medical Sciences | Beijing | Beijing Municipality | 100021 | China |
| Beijing Cancer Hospital | Beijing | Beijing Municipality | 100142 | China |
| Peking Union Medical College Hospital | Beijing | Beijing Municipality | 100730 | China |
| Chinese Pla General Hospital | Beijing | Beijing Municipality | 100853 | China |
| Beijing Chest Hospital, Capital Medical University | Beijing | Beijing Municipality | 101149 | China |
| Daping Hospital, Third Military Medical University | Chongqing | Chongqing Municipality | 400042 | China |
| Cancer Center of Guangzhou Medical University | Guangzhou | Guangdong | 510030 | China |
| Guangzhou Institute of Respiratory Disease | Guangzhou | Guangdong | 510120 | China |
| Cancer Hospital of Shantou University Medical College | Shantou | Guangdong | 515031 | China |
| The First Affiliated Hospital of Guangxi Medical University | Nanning | Guangxi | 530021 | China |
| The Affiliated Hospital of Zunyi Medical College | Zunyi | Guizhou | 563000 | China |
| Hainan General Hospital | Haikou | Hainan | 570206 | China |
| Harbin Medical University Cancer Hospital | Harbin | Heilongjiang | 150000 | China |
| Henan Cancer Hospital | Zhengzhou | Henan | 450000 | China |
| Tongji Hospital of Tongji Medical College Huazhong University of Science and Technology | Wuhan | Hubei | 430030 | China |
| Hubei Cancer Hospital | Wuhan | Hubei | 430079 | China |
| Changsha Central Hospital | Changsha | Hunan | 410004 | China |
| Xiangya Hospital of Central South University | Changsha | Hunan | 410008 | China |
| Hunan Cancer Hospital | Changsha | Hunan | 410013 | China |
| Jiangsu Province Hospital | Nanjing | Jiangsu | 210029 | China |
| Nantong Tumor Hospital Branch North | Nantong | Jiangsu | 226000 | China |
| The Second Affiliated Hospital of Soochow University | Suzhou | Jiangsu | 215000 | China |
| Xuzhou Central Hospital | Xuzhou | Jiangsu | 221000 | China |
| Jiangxi Province Cancer Hospital | Nanchang | Jiangxi | 330029 | China |
| Jilin Cancer Hospital | Changchun | Jilin | 130021 | China |
| The First Hospital of Jilin University | Changchun | Jilin | 130021 | China |
| The First Hospital of China Medical University | Shenyang | Liaoning | 110001 | China |
| Liaoning Cancer Hospital and Institute | Shenyang | Liaoning | 110042 | China |
| The First Affiliated Hospital of Xian Jiaotong University | Xi'an | Shaanxi | 710061 | China |
| Jinan Central Hospital | Jinan | Shandong | 250013 | China |
| Linyi Cancer Hospital | Linyi | Shandong | 276001 | China |
| Rui Jin Hospital Shanghai Jiao Tong University School of Medicine | Shanghai | Shanghai Municipality | 200025 | China |
| Shanghai Pulmonary Hospital | Shanghai | Shanghai Municipality | 200433 | China |
| Sichuan Academy of Medical Sciences and Sichuan Provincial Peoples Hospital | Chengdu | Sichuan | 610071 | China |
| Tianjin Medical University Cancer Institute and Hospital | Tianjin | Tianjin Municipality | 300060 | China |
| Tianjin Union Medical Center (Nankai University Affiliated Hospital) | Tianjin | Tianjin Municipality | 300121 | China |
| The First Affiliated Hospital of Xinjiang Medical University | Ürümqi | Xinjiang | 830054 | China |
| Yunnan Cancer Hospital | Kunming | Yunnan | 650100 | China |
| The First Affiliated Hospital, Zhejiang University School of Medicine | Hangzhou | Zhejiang | 310003 | China |
| Zhejiang University College of Medicine Second Affiliated Hospital | Hangzhou | Zhejiang | 310009 | China |
| Zhejiang Cancer Hospital | Hangzhou | Zhejiang | 310022 | China |
| The First Affiliated Hospital of Wenzhou Medical University | Wenzhou | Zhejiang | 325000 | China |
| Hospital of Lithuanian University of Health Sciences Kaunas Clinics Branch Oncology Hospital | Kaunas | 45427 | Lithuania |
| Hospital of Lithuanian University of Health Sciences Kaunas Clinics | Kaunas | 50103 | Lithuania |
| National Cancer Institute | Vilnius | 8660 | Lithuania |
| Investigacion Onco Farmaceutica (Oncotech) | La Paz | 23040 | Mexico |
| Fundacion Rodolfo Padilla Padilla, Ac | León | 37000 | Mexico |
| Health Pharma Professional Research Sa de Cv | Mexico City | 03100 | Mexico |
| Medica Sur | México | 14050 | Mexico |
| Accelerium S de Rl de Cv | Monterrey | 64000 | Mexico |
| Centro de Investigacion Clinica Chapultepec Sa de Cv | Morelia | 58260 | Mexico |
| Oaxaca Site Management Organization Sc | Oaxaca City | 68000 | Mexico |
| Auckland City Hospital | Auckland | 1023 | New Zealand |
| Waikato Hospital | Hamilton Waikato | 3204 | New Zealand |
| Tauranga Hospital | Tauranga | 3112 | New Zealand |
| Szpital Specjalistyczny Brzeziny | Brzeziny | 95-060 | Poland |
| Uniwersyteckie Centrum Kliniczne | Gdansk | 80-952 | Poland |
| Centrum Terapii Wspolczesnej Jm Jasnorzewska Sp Komandytowo Akcyjna | Lodz | 90-242 | Poland |
| Salve Medica Sp Z Oo, Sp Komandytowa | Lodz | 91-211 | Poland |
| Zespol Gruzlicy I Chorob Pluc W Olsztynie Oddz Onkologii Z Pododdz Chemioterapii Nowotworow Puc | Olsztyn | 10-357 | Poland |
| Mazowiecki Szpital Specjalistyczny W Ostrolece Im Dr Jozefa Psarskiego | Ostrołęka | 07-410 | Poland |
| Mazowieckie Centrum Leczenia Chorob Pluc I Gruzlicy | Otwock | 05-400 | Poland |
| Izerskie Centrum Pulmonologii I Chemioterapii Izer Med Spolka Z Oo | Szklarska Porba | 58-580 | Poland |
| Centrum Onkologii Instytut Im M Sklodowskiej Curie | Warsaw | 02-034 | Poland |
| Arkhangelsk Regional Clinical Oncological Dispensary | Arkhangelsk | Arkhangelskaya oblast | 163045 | Russia |
| Irkutsk Regional Oncology Dispensary | Irkutsk | Irkutiskaya Oblast' | 664035 | Russia |
| Fsbi of Higher Educationogarev Mordovia State University | Saransk | Mordoviya, Respublika | 430005 | Russia |
| N N Blokhin Russian Cancer Research Center Konstantin Laktionov | Moscow | Moscow | 115478 | Russia |
| Fsbi Russian Scientific Center of Radiology and Nuclear Medicine of the Moh of the Rf | Moscow | Moscow | 117837 | Russia |
| Vitamed Llc | Moscow | Moscow | 121309 | Russia |
| Bih of Omsk Region Clinical Oncology Dispensary | Omsk | Omsk Oblast | 644013 | Russia |
| Sbei Hpe Ryazan State Medical University Na Academician Ip Pavlov of the Moh of the Rf | Ryazan | Ryazan Oblast | 390026 | Russia |
| Private Medical Institution Evromedservis | Pushkin | Sankt-Peterburg | 7042 | Russia |
| Pavlov First Saint Petersburg State Medical University | SaintPetersburg | Sankt-Peterburg | 197022 | Russia |
| Llc Center of Palliative Medicine Devita | SaintPetersburg | Sankt-Peterburg | 197183 | Russia |
| Fsbi Clinical Research and Practical Center For Specialized Medical Care (Oncology) | SanktPetersburg | Sankt-Peterburg | 197758 | Russia |
| State Budgetary Healthcare Institution Volgograd Regional Clinical Oncology Dispensary | Volgograd | Volgograd Oblast | 400138 | Russia |
| Fsbi National Medical Research Center For Oncology Na Nn Petrov of the Moh of the Rf | SaintPetersburg | 197758 | Russia |
| Fakultna Nemocnica S Poliklinikou Fd Roosevelta | Banská Bystrica | 97409 | Slovakia |
| Nemocnica S Poliklinikou Sv Jakuba, No Bardejov | Bardejov | 8501 | Slovakia |
| Narodny Onkologicky Ustav | Bratislava | 83310 | Slovakia |
| Vychodoslovensky Onkologicky Ustav, As | Košice | 4191 | Slovakia |
| Nemocnica S Poliklinikou Stefana Kukuru Michalovce, As | Michalovce | 7101 | Slovakia |
| Fakultna Nemocnica S Poliklinikou Nove Zamky | Nové Zámky | 94002 | Slovakia |
| Nemocnica Na Okraji Mesta, No | Partizánske | 95814 | Slovakia |
| Poko Poprad Sro | Poprad | 5801 | Slovakia |
| Acibadem Adana Hospital | Adana | 01130 | Turkey (Türkiye) |
| Hacettepe University | Ankara | 6100 | Turkey (Türkiye) |
| Nonu Universitesi Tip Fakultesi | Battalgazi | 44280 | Turkey (Türkiye) |
| Tr Trakya University Health Research and Application Center (Hospital) | Edirne | 22030 | Turkey (Türkiye) |
| Bakirkoy Dr Sadi Konuk Teaching and Research Hospital | Istanbul | 34147 | Turkey (Türkiye) |
| Goztepe Prof Dr Suleyman Yalcin Ehir Hastanesi | Istanbul | 34722 | Turkey (Türkiye) |
| Ege University Medical Faculty | Izmir | 35100 | Turkey (Türkiye) |
| Kocaeli Universitesi Tip Fakultesi | Kocaeli | 41380 | Turkey (Türkiye) |
| Necmettin Erbakan University Selcuklu Faculty of Medicine | Meram | 42090 | Turkey (Türkiye) |
| Iu C, Clinical Research Excellence Application and Research Center | Stanbul | 34098 | Turkey (Türkiye) |
| Namik Kemal University | Tekirdağ | 59100 | Turkey (Türkiye) |
| Result |
| Huang D, Zhou C, Barnes G, Ma Y, Li S, Zhan L, Tang B. The effects of tislelizumab treatment on the health-related quality of life of patients with advanced non-small cell lung cancer. Cancer Med. 2023 Aug;12(16):17403-17412. doi: 10.1002/cam4.6361. Epub 2023 Aug 17. |
Participants received docetaxel 75 mg/m² IV once every 3 weeks until disease progression, unacceptable toxicity, or withdrawal of informed consent, whichever occurred first.
| Received Treatment |
|
| COMPLETED |
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| NOT COMPLETED |
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Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Tislelizumab | Participants received tislelizumab 200 mg IV once every 3 weeks until disease progression, unacceptable toxicity, or withdrawal of informed consent, whichever occurred first. |
| BG001 | Docetaxel | Participants received docetaxel 75 mg/m² IV once every 3 weeks until disease progression, unacceptable toxicity, or withdrawal of informed consent, whichever occurred first. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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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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| Histology | Count of Participants | Participants |
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| Current Line of Therapy | Count of Participants | Participants |
| ||||||||||||||||
| PD-L1 Expression | Participants were tested for PD-L1 expression by a central laboratory using VENTANA SP263 immunohistochemistry assay. | Count of Participants | Participants |
| |||||||||||||||
| Smoking Status | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Overall Survival (OS) in All Participants (Co-primary Endpoint) | OS was defined as the time from randomization to death from any cause. Median OS was calculated using the Kaplan-Meier method. Data for participants who were not reported as having died at the time of analysis were censored at the date they were last known to be alive. Data for participants who did not have postbaseline information were censored at the date of randomization. | The Intent-to-Treat (ITT) Analysis Set included all randomized patients | Posted | Median | 95% Confidence Interval | months | From randomization to the data cutoff date of 10 August 2020; up to 32.4 months |
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| Primary | Overall Survival (OS) in Programmed Cell Death Protein Ligand-1 (PD-L1)-Positive Participants (Co-primary Endpoint) | OS was defined as the time from randomization to death from any cause. Median OS was calculated using the Kaplan-Meier method. Data for participants who were not reported as having died at the time of analysis were censored at the date they were last known to be alive. Data for participants who did not have postbaseline information were censored at the date of randomization. | The PD-L1-Positive Analysis Set included all randomized patients whose tumors were PD-L1 positive (defined as ≥ 25% of tumor cells with PD-L1 membrane staining). | Posted | Median | 95% Confidence Interval | months | From randomization up to the final efficacy analysis data cut-off date of 15 July 2021; Up to 43 months |
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| Secondary | Objective Response Rate (ORR) in All Participants | Objective response rate is defined as the percentage of participants who had a 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 included computed tomography (CT) scans or magnetic resonance imaging (MRI), with preference for CT, of the chest, abdomen, and pelvis. CR: 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: At least a 30% decrease in the size of target lesions and no progression of non-target lesions and no new lesions, or disappearance of all target lesions with persistence of one or more non-target lesion(s) and/or maintenance of tumor marker level above the normal limits and no new lesions. | Intent-to-Treat Analysis Set | Posted | Number | 95% Confidence Interval | percentage of participants | From randomization up to the final efficacy analysis data cut-off date of 15 July 2021; Up to 43 months |
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| Secondary | Objective Response Rate in PD-L1-Positive Participants | Objective response rate is defined as the percentage of participants who had a 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 included computed tomography (CT) scans or magnetic resonance imaging (MRI), with preference for CT, of the chest, abdomen, and pelvis. CR: 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: At least a 30% decrease in the size of target lesions and no progression of non-target lesions and no new lesions, or disappearance of all target lesions with persistence of one or more non-target lesion(s) and/or maintenance of tumor marker level above the normal limits and no new lesions. | The PD-L1-Positive Analysis Set included all randomized patients whose tumors were PD-L1 positive (defined as ≥ 25% of tumor cells with PD-L1 membrane staining). | Posted | Number | 95% Confidence Interval | percentage of participants | From randomization up to the final efficacy analysis data cut-off date of 15 July 2021; Up to 43 months |
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| Secondary | Duration of Response (DOR) for All Responders | DoR was defined as the time from the first documented objective response to documented 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 (PD): At least a 20% increase in the size of target lesions with an absolute increase of at least 5 mm, or unequivocal progression of existing non-target lesions, or the appearance of any new lesions. | Participants in the Intent-to-Treat Analysis Set who had an objective response | Posted | Median | 95% Confidence Interval | months | From randomization up to the final efficacy analysis data cut-off date of 15 July 2021; Up to 43 months |
|
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| Secondary | Duration of Response (DOR) in PD-L1-Positive Responders | DoR was defined as the time from the first documented objective response to documented 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 (PD): At least a 20% increase in the size of target lesions with an absolute increase of at least 5 mm, or unequivocal progression of existing non-target lesions, or the appearance of any new lesions. | Participants in the PD-L1-Positive Analysis Set who had an objective response | Posted | Median | 95% Confidence Interval | months | From randomization up to the final efficacy analysis data cut-off date of 15 July 2021; Up to 43 months |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Progression-free Survival (PFS) in All Participants | PFS was defined as the time from randomization to the first objectively documented disease progression as assessed by the investigator per RECIST v1.1 or death from any cause, whichever occurred first. Median PFS was estimated using the Kaplan-Meier method. | Intent-to-Treat Analysis Set | Posted | Median | 95% Confidence Interval | months | From randomization up to the final efficacy analysis data cut-off date of 15 July 2021; Up to 43 months |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Progression-free Survival in PD-L1 Positive Participants | PFS was defined as the time from randomization to the first objectively documented disease progression as assessed by the investigator per RECIST v1.1 or death from any cause, whichever occurred first. Median PFS was estimated using the Kaplan-Meier method. | PD-L1 Positive Analysis Set | Posted | Median | 95% Confidence Interval | months | From randomization up to the final efficacy analysis data cut-off date of 15 July 2021; Up to 43 months |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Global Health Status (GHS)/Quality of Life (QOL) Score | The EORTC QLQ-30 contains 30 questions that incorporate 5 functional scales (physical functioning, role functioning, emotional functioning, cognitive functioning, and social functioning), 1 global health status scale, 3 symptom scales (fatigue, nausea and vomiting, and pain), and 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). The participant answers questions about their health during the past week. There are 28 questions answered on a 4-point scale where 1 = Not at all (best) and 4 = Very Much (worst) and two global health quality of life (QOL) questions answered on a 7-point scale where 1 = Very poor and 7 = Excellent. Raw scores are transformed into a 0 to 100 scale via linear transformation. Higher scores in GHS/QoL score indicates better quality of life. | The HRQoL Analysis Set included all randomized participants who received ≥ 1 dose of study drug and completed ≥ 1 HRQoL assessment; participants with available data at baseline and Cycle 6 are included in the analysis. | Posted | Least Squares Mean | 95% Confidence Interval | score on a scale | Baseline and Cycle 6 (each cycle was 3 weeks) |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 Items (QLQ-LC13) Coughing, Dyspnoea, and Chest Pain Scores | The EORTC QLQ-LC13 is the lung cancer module of the QLQ-C30 and measures lung cancer-specific disease and treatment symptoms. It includes 13 questions about specific symptoms in which participants respond based on a 4-point scale, where 1 is "not at all" and 4 is "very much". Raw scores are transformed into a 0 to 100 scale via linear transformation. Lower scores indicate an improvement in symptoms. | The HRQoL Analysis Set included all randomized participants who received ≥ 1 dose of study drug and completed ≥ 1 HRQoL assessment; participants with available data at baseline and Cycle 6 are included in the analysis. | Posted | Least Squares Mean | 95% Confidence Interval | score on a scale | Baseline and Cycle 6 (each cycle was 3 weeks) |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in European Quality of Life 5-Dimensions, 5-level (EQ-5D-5L) Visual Analogue Scale (VAS) | The EQ-5D-5L measures health outcomes using a VAS to record a participant's self-rated health on a scale from 0 to 100, where 100 is 'the best health you can imagine' and 0 is 'the worst health you can imagine.' A higher score indicates better health outcomes. | The HRQoL Analysis Set included all randomized participants who received ≥ 1 dose of study drug and completed ≥ 1 HRQoL assessment; participants with available data at Baseline and Cycle 6 are included in the analysis. | Posted | Mean | Standard Deviation | score on a scale | Baseline and Cycle 6 (each cycle was 3 weeks) |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | An adverse event is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study drug, whether considered related to study drug or not. The investigator assessed the severity of each AE and graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) v4.03 as defined below:
| The Safety Analysis Set included all randomized patients who received ≥ 1 dose of study drug. | Posted | Count of Participants | Participants | From first dose of study drug to 30 days after last dose, up to the study completion date cut-off date of 18 January 2024 (up to approximately 63 months) |
|
All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Tislelizumab | Participants received tislelizumab 200 mg IV once every 3 weeks until disease progression, unacceptable toxicity, or withdrawal of informed consent, whichever occurred first. | 409 | 535 | 192 | 534 | 498 | 534 |
| EG001 | Docetaxel | Participants received docetaxel 75 mg/m² IV once every 3 weeks until disease progression, unacceptable toxicity, or withdrawal of informed consent, whichever occurred first. | 223 | 270 | 84 | 258 | 246 | 258 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Agranulocytosis | Blood and lymphatic system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Disseminated intravascular coagulation | Blood and lymphatic system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Lymphadenitis | Blood and lymphatic system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Acute coronary syndrome | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Acute left ventricular failure | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Atrioventricular block | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Cardiac tamponade | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Cardiogenic shock | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Coronary artery disease | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Myocardial ischaemia | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Myocarditis | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Pericardial effusion | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Adrenal insufficiency | Endocrine disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Glucocorticoid deficiency | Endocrine disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Immune-mediated adrenal insuficiency | Endocrine disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Retinal tear | Eye disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Duodenal ulcer | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Enteritis | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Immune-mediated enterocolitis | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Intestinal obstruction | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Pancreatitis | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Pancreatitis acute | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Chest discomfort | General disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Chills | General disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Death | General disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 24.0 | Systematic Assessment |
| |
| General physical health deterioration | General disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Malaise | General disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Multiple organ dysfunction syndrome | General disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Acute hepatic failure | Hepatobiliary disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Autoimmune hepatitis | Hepatobiliary disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Cholecystitis acute | Hepatobiliary disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Drug-induced liver injury | Hepatobiliary disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Hepatic function abnormal | Hepatobiliary disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Hepatitis | Hepatobiliary disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Jaundice cholestatic | Hepatobiliary disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Drug hypersensitivity | Immune system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Otitis media chronic | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Pneumonia bacterial | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Pneumonia haemophilus | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Cerebral radiation injury | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
| |
| Clavicle fracture | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
| |
| Femur fracture | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
| |
| Forearm fracture | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
| |
| Ligament rupture | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
| |
| Limb injury | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
| |
| Road traffic accident | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
| |
| Spinal compression fracture | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
| |
| Spinal fracture | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
| |
| Upper limb fracture | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 24.0 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 24.0 | Systematic Assessment |
| |
| Blood creatine phosphokinase increased | Investigations | MedDRA 24.0 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA 24.0 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA 24.0 | Systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA 24.0 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Electrolyte imbalance | Metabolism and nutrition disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Hypoproteinaemia | Metabolism and nutrition disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Ketoacidosis | Metabolism and nutrition disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Type 1 diabetes mellitus | Metabolism and nutrition disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Joint effusion | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Myositis | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Pathological fracture | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Spinal pain | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Cancer pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.0 | Systematic Assessment |
| |
| Colon adenoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.0 | Systematic Assessment |
| |
| Peritumoural oedema | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.0 | Systematic Assessment |
| |
| Tumour associated fever | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.0 | Systematic Assessment |
| |
| Tumour pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.0 | Systematic Assessment |
| |
| Brain oedema | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Cerebral artery occlusion | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Cerebral infarction | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Epilepsy | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Haemorrhage intracranial | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Hemiparesis | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Intracranial pressure increased | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Seizure | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Spinal cord compression | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Transient ischaemic attack | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Visual pathway disorder | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Suicide attempt | Psychiatric disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Chronic kidney disease | Renal and urinary disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Immune-mediated lung disease | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Interstitial lung disease | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Pneumothorax spontaneous | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Pulmonary haemorrhage | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Pulmonary thrombosis | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Tracheal stenosis | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Wheezing | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Embolism venous | Vascular disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Hypovolaemic shock | Vascular disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Superior vena cava syndrome | Vascular disorders | MedDRA 24.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Hyperthyroidism | Endocrine disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Hypothyroidism | Endocrine disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Cataract | Eye disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Toothache | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Chest discomfort | General disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Malaise | General disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 24.0 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 24.0 | Systematic Assessment |
| |
| Bilirubin conjugated increased | Investigations | MedDRA 24.0 | Systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA 24.0 | Systematic Assessment |
| |
| Blood bilirubin increased | Investigations | MedDRA 24.0 | Systematic Assessment |
| |
| Blood creatine phosphokinase MB increased | Investigations | MedDRA 24.0 | Systematic Assessment |
| |
| Blood creatine phosphokinase increased | Investigations | MedDRA 24.0 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA 24.0 | Systematic Assessment |
| |
| Blood lactate dehydrogenase increased | Investigations | MedDRA 24.0 | Systematic Assessment |
| |
| Blood thyroid stimulating hormone increased | Investigations | MedDRA 24.0 | Systematic Assessment |
| |
| Blood urea increased | Investigations | MedDRA 24.0 | Systematic Assessment |
| |
| Gamma-glutamyltransferase increased | Investigations | MedDRA 24.0 | Systematic Assessment |
| |
| Lymphocyte count decreased | Investigations | MedDRA 24.0 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA 24.0 | Systematic Assessment |
| |
| Neutrophil count increased | Investigations | MedDRA 24.0 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA 24.0 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA 24.0 | Systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA 24.0 | Systematic Assessment |
| |
| White blood cell count increased | Investigations | MedDRA 24.0 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Hyperuricaemia | Metabolism and nutrition disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Hypochloraemia | Metabolism and nutrition disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Hypoproteinaemia | Metabolism and nutrition disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Cancer pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Proteinuria | Renal and urinary disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 24.0 | 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 | Oct 16, 2020 | Jan 15, 2025 | SAP_001.pdf |
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000707970 | tislelizumab |
| D000077143 | Docetaxel |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
Not provided
Not provided
| Male |
|
| Asian |
|
| Black or African American |
|
| Native Hawaiian or Other Pacific Islander |
|
| White |
|
| Other |
|
| Non-Squamous |
|
| Third line |
|
| < 25% of tumor cells |
|
| Missing |
|
| Current |
|
| Former |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
|
|
|
|
Participants received docetaxel 75 mg/m² IV once every 3 weeks until disease progression, unacceptable toxicity, or withdrawal of informed consent, whichever occurred first.
|
|
|
| Participants |
|
|
|
| Counts |
|---|
| Participants |
|
|
|
|
|
|
|
| Docetaxel |
Participants received docetaxel 75 mg/m² IV once every 3 weeks until disease progression, unacceptable toxicity, or withdrawal of informed consent, whichever occurred first. |
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
|
|
| Docetaxel |
Participants received docetaxel 75 mg/m² IV once every 3 weeks until disease progression, unacceptable toxicity, or withdrawal of informed consent, whichever occurred first. |
|
|