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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1216-4294 | Other Identifier | WHO | |
| 2018-001132-22 | EudraCT Number |
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BeiGene and Celgene Corporation terminated the parties' global collaboration for the compound, pending the acquisition of Celgene by Bristol Myers Squibb
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| Name | Class |
|---|---|
| BeiGene | INDUSTRY |
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This is a Phase 3, randomized, double-blind, placebo-controlled multicenter global study designed to compare the efficacy and safety of tislelizumab in combination with concurrent chemoradiotherapy (cCRT) followed by tislelizumab monotherapy versus cCRT alone, and tislelizumab given sequentially after cCRT versus cCRT alone, in newly diagnosed stage III subjects with locally advanced, unresectable non-small cell lung cancer (NSCLC). The primary endpoint is centrally-assessed progression free survival (PFS) in the intent-to-treat (ITT) population. .
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1:Tislelizumab + cCRT followed by tislelizumab monotherapy | Experimental | Tislelizumab 200 mg is administered by intravenous (IV) administration and given together upfront with concurrent platinum-based chemoradiotherapy (cCRT) for the first 6 weeks, followed by tislelizumab 200 mg by IV adminstration monotherapy. The standard platinum-based chemotherapy options include carboplatin/ paclitaxel and cisplatin/etoposide |
|
| Arm 2: Placebo + cCRT followed by tislelizumab monotherapy | Experimental | Placebo is given with concurrent platinum-based chemoradiotherapy (cCRT) for the first 6 weeks, followed by tislelizumab 200 mg by IV administration monotherapy. The standard platinum-based chemotherapy options include carboplatin/paclitaxel and cisplatin/etoposide. |
|
| Arm 3: Placebo + cCRT followed by placebo monotherapy | Placebo Comparator | Placebo is given with concurrent platinum-based chemoradiotherapy (cCRT) for the first 6 weeks, followed by placebo monotherapy. The standard platinum-based chemotherapy options include carboplatin/paclitaxel and cisplatin/etoposide. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tislelizumab | Drug | PD-1 inhibitor (monoclonal antibody against PD-1) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression-Free Survival (PFS) | Progression-free survival was defined as the time from the date of randomization to the date of the first objectively tumor progression as assessed by the blinded independent central review per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 criteria (documented by radiological assessment) or death (any cause) on or prior to the clinical cut-off date, which ever occurred first. Stable disease-neither sufficient shrinkage to qualify for PR nor sufficient increase of lesions to qualify for Progressive disease (PD)• Progressive Disease- At least a 20% increase in the sum of diameters of target lesions from nadir. | Up to approximately 5 years; date of randomization to the date of tumor progression or death; until study withdrawal date of 26 June 2019 |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS) | Overall survival was defined as the time between randomization of treatment and death from any cause. | Up to approximately 5 years; date of randomization to date of death from any cause. |
| Overall Survival at 24 Months |
Not provided
Inclusion Criteria:
Newly diagnosed, histologically confirmed, locally advanced, stage III unresectable non small cell lung cancer (NSCLC).
Staging will be confirmed at screening by positron emission tomography-computed tomography (PET/CT) and brain imaging by magnetic resonance imaging (MRI) or computed tomography (CT) with contrast.
Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1.
Epidermal growth factor receptor (EGFR) mutation and anaplastic lymphoma kinase (ALK) gene translocation status available prior to randomization.
Provision of fresh or archival tumor tissue or discussion with Sponsor.
Adequate hematologic and end-organ function.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marie Nguyen, MD | Celgene | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| USC Norris Comprehensive Cancer Center | Los Angeles | California | 90033 | United States | ||
| Cancer Specialists of North Florida - Jacksonville |
Not provided
One participant was enrolled in the United States before the study was terminated.
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| ID | Title | Description |
|---|---|---|
| FG000 | Tislelizumab + Concurrent Chemoradiotherapy -Tislelizumab | Participants were to receive 2 cycles of tislelizumab 200 mg by intravenous (IV) infusion every 3 weeks (Q3W) with concurrent chemoradiotherapy (cCRT), followed by monotherapy with tislelizumab 200 mg IV Q3W until disease progression, death, unacceptable toxicity, subject or physician decision, withdrawal of consent or treatment discontinuation for another reason. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
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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 | Sep 20, 2018 | Jun 26, 2020 |
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|
| Concurrent chemoradiotherapy (cCRT) | Drug | Chemotherapy options include carboplatin/paclitaxel and cisplatin/etoposide per standard of care. Radiotherapy will also be given concurrently with chemotherapy. |
|
| Placebo | Other | Placebo |
|
Overall survival was defined as the time between randomization of treatment and death from any cause.
| Up to approximately 24 months |
| Percentage of Participants Who Achieved a Best Overall Response of Complete Response or Partial Response | Overall Response was defined as percentage of participants who had a radiologic confirmed complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1) guidelines, between Day 1 of treatment and subsequent anti-cancer therapy, death or study discontinuation. Complete response was defined as the disappearance of all target lesions; partial response (PR) is defined as at least a 30% decrease in the sum of diameters of target lesions from baseline; stable disease-neither sufficient shrinkage to qualify for PR nor sufficient increase of lesions to qualify for progressive disease (PD). | Up to approximately 5 years |
| Duration of Response | Duration of Response is defined as the time from the first occurrence of a documented objective response to the time of relapse, as determined by blinded independent central review per RECIST v1.1, or death from any cause, whichever comes first. | Up to approximately 5 years |
| Percentage of Participants Alive and Progression-Free at 12 Months (APF12) | Progression-free survival was defined as the time from the date of randomization to the date of the first objectively tumor progression as assessed by the blinded independent central review per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 criteria (documented by radiological assessment) or death (any cause) on or prior to the clinical cut-off date, which ever occurred first | Up to 12 months |
| Percentage of Participants Alive and Progression-free at 18 Months (APF18) | Progression-free survival was defined as the time from the date of randomization to the date of the first objectively tumor progression as assessed by the blinded independent central review per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 criteria (documented by radiological assessment) or death (any cause) on or prior to the clinical cut-off date, which ever occurred first | Up to approximately 18 months |
| Time to Distant Metastasis (TTDM) | TTDM was defined as the time from the date of randomization until the first date of distant metastasis or death in the absence of distant metastasis. Distant metastasis was defined as any new lesion that is outside of the radiation field according to RECIST v1.1 or proven by biopsy. | Up to approximately 5 years |
| Number of Participants With Treatment Emergent Adverse Events (TEAEs) | TEAEs include any adverse events (AEs) that had an onset date or a worsening in severity from baseline on or after the first dose of study drug up to 30 days following study drug discontinuation or initiation of new anticancer therapy, whichever occurred first. TEAEs also included all immune-related AEs recorded up to 90 days after the last dose of tislelizumab or placebo, regardless of whether or not the particpant started a new anticancer therapy. In addition, any serious AE with an onset date more than 30 days after the last dose of study drug that is assessed by the investigator as related to study drug were considered a TEAE." | From first dose of study drug up to study withdrawal date of 26 June 2019; 15 days. |
| Number of Participants With Lung Cancer Symptoms Assessed by the Corresponding Domains of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC-QLQ-C30) and Lung-Cancer Specific QLQ-LC13 | The EORTC QLQ-C30 is a 30-item, questionnaire assessing quality of life (QoL), psychosocial burden and physical symptoms. It is classified into 15 domains: 5 functional subscales (physical functioning, role functioning, emotional functioning, cognitive functioning, and social functioning); 3 multi-item symptom subscales (fatigue, nausea/vomiting, and pain); each item is measured on a 4 point response scale; (not at all, a little, quite a bit, very much), with the exception of the 2 items measuring global health and QoL, (measured on a 7-point response scale). Scores are linearly transformed to 0 to 100 scores. Scores vary from 0 (worst) to 100 (best) for the functional dimensions and GHS, and from 0 (best) to 100 (worst) for the symptom dimensions; higher scores = better QoL, better functioning, or more severe symptoms, respectively. The LC13 covers 13 typical symptoms of lung cancer patients, such as coughing, pain, dyspnea, sore mouth, peripheral neuropathy, and hair loss. | Up to approximately 5 years |
| Percentage of Participants Who Would Have Continued on to Monotherapy Phase | Included the percentage of participants who would have received at least one dose of tislelizumab or placebo in the monotherapy phase before progression. | Up to approximately 5 years |
| Jacksonville |
| Florida |
| 32258-5472 |
| United States |
| Bond Clinic, P.A. | Winter Haven | Florida | 33881 | United States |
| University of Chicago Medical Center | Chicago | Illinois | 60637 | United States |
| Fort Wayne Medical Oncology and Hematology | Fort Wayne | Indiana | 46845 | United States |
| Appalachian Regional Healthcare, Inc. | Hazard | Kentucky | 41701 | United States |
| Norton Healthcare - Norton Cancer Institute | Louisville | Kentucky | 40202 | United States |
| Center For Cancer and Blood Disorders | Bethesda | Maryland | 20817 | United States |
| University of Mississippi Medical Center | Jackson | Mississippi | 39216 | United States |
| Dayton Physicians, LLC | Kettering | Ohio | 45409 | United States |
| Mercy Health Youngstown Hospital, LLC | Youngstown | Ohio | 44504 | United States |
| Allegheny General Hospital | Pittsburgh | Pennsylvania | 15212 | United States |
| Millennium Oncology | Houston | Texas | 77090 | United States |
| Medical Oncology Associates, P.S. | Spokane | Washington | 99208 | United States |
| Universitair Ziekenhuis Brussel | Brussels | 1090 | Belgium |
| Cliniques Universitaires Saint-Luc | Brussels | 1200 | Belgium |
| Jewish General Hospital | Montreal | Quebec | H3T 1E2 | Canada |
| Cancer Hospital Chinese Academy of Medical Sciences | Beijing | 100021 | China |
| Chinese PLA General Hospital / 307 Hospital | Beijing | 100071 | China |
| Beijing Cancer Hospital - Beijing Institute for Cancer Research | Beijing | 100142 | China |
| Bengbu Medical College - First Affiliated Hospital | Bengbu Shi | 233004 | China |
| Jilin Province Cancer Hospital | Changchun | 130012 | China |
| First Hospital of Jilin University | Changchun | 130021 | China |
| Central South University - Xiangya School of Medicine - Hunan Cancer Hospital | Changsha | 410013 | China |
| Central South University - Xiangya School of Medicine - Hunan Cancer Hospital | Changsha-shi | 410013 | China |
| Sichuan Cancer Hospital & Institute | Chengdu | 610041 | China |
| Sichuan University - West China Hospital | Chengdu | 610041 | China |
| Foshan First People's Hospital | Foshan | 528000 | China |
| Cancer Center of Guangzhou Medical University | Guangzhou | 510095 | China |
| The First Affiliated Hospital of Guangzhou Medical University | Guangzhou | 510120 | China |
| Zhejiang University School of Medicine - The Second Affiliated Hospital | Hangzhou | 310016 | China |
| Zhejiang Medical University - Zhejiang Cancer Hospital | Hangzhou | 310022 | China |
| The First Affiliated Hospital of Harbin Medical University | Harbin | 150081 | China |
| Yunnan Cancer Hospital | Kunming | 650118 | China |
| Guangxi Tumour Institute and Hospital | Nanning | 530021 | China |
| Nantong Tumor Hospital | Nantong | 226361 | China |
| Fudan University Shanghai Cancer Center | Shanghai | 200032 | China |
| Shanghai Chest Hospital | Shanghai Shi | 200030 | China |
| Chongqing Cancer Hospital | Shapingbaqu | 400030 | China |
| Liaoning Cancer Hospital & Institute | Shenyang | 110042 | China |
| The First Hospital of Xinjiang Medical University | Ürümqi | 830054 | China |
| Union Hospital, Tongji Medical College, Huazhong University of Science and Technology | Wuhan | 430022 | China |
| Zhongnan Hospital of Wuhan University | Wuhan | 430023 | China |
| Tongji Hospital, Tongji Medical College of Huazhong University of Science and Technology | Wuhan | 430030 | China |
| The First Affiliated Hospital of Xi'an Jiaotong University | Xi'an | 710061 | China |
| First Hospital of Xiamen | Xiamen | 361003 | China |
| Fujian Medical University - Fujian Provincial Cancer Hospital | Xidajie | 350014 | China |
| The Affiliated Hospital of Xuzhou Medical University | Xuzhou | 221002 | China |
| Zhengzhou University (ZZU) - Henan Cancer Hospital | Zhengzhou | 450008 | China |
| The First Affiliated Hospital of Zhengzhou University | Zhengzhou | 450052 | China |
| Tampereen yliopistollinen sairaala | Tampere | 33521 | Finland |
| Turku University Hospital | Turku | 20521 | Finland |
| Centre Francois Baclesse | Caen | 14076 | France |
| Clinique Victor Hugo | Le Mans | 72015 | France |
| Institut de Cancerologie de l'Ouest (ICO) - Saint-Herblain | Saint-Herblain | 44805 | France |
| Medical Study Company NORD-WEST GmbH Oncology Aurich | Aurich | 26603 | Germany |
| Helios Klinikum Emil Von Behring | Berlin | 14165 | Germany |
| Kliniken der Stadt Koln gGmbH - Krankenhaus Merheim | Cologne | 51109 | Germany |
| Florence Nightingale KH der Kaiserwerther Diakonie | Düsseldorf | 40489 | Germany |
| Klinikum Esslingen GmbH | Esslingen am Neckar | 73730 | Germany |
| Asklepios Fachkliniken Muenchen Gauting | Gauting | 82131 | Germany |
| Oncological practice Goslar | Goslar | 38642 | Germany |
| Evangelisches Krankenhaus Hamm | Hamm | 59063 | Germany |
| Health Nordhessen Holding AG - Klinikum Kassel - Medical Clinic IV | Kassel | 34125 | Germany |
| Klinik Loewenstein gGmbH | Löwenstein | 74245 | Germany |
| LMU Klinikum der Universität | München | 81377 | Germany |
| St. Antonius-Hospital | Schweiler | 52249 | Germany |
| Medizinische Studiengesellschaft Nord-West | Westerstede | 26655 | Germany |
| Sotiria Chest Hospital of Athens | Athens | 11527 | Greece |
| IASO General | Athens | 15562 | Greece |
| University General Hospital of Heraklion | Heraklion | 71110 | Greece |
| Agioi Anargyroi Cancer Hospital | Kifissia | 14564 | Greece |
| Metaxa Cancer Hospital of Piraeus | Piraeus | 18537 | Greece |
| Interbalkan Medical Center of Thessaloniki | Pylaia | 570 01 | Greece |
| University General Hospital of Patras | Rio Patras | 26500 | Greece |
| Bioclinic Thessaloniki Galinos clinic | Thessaloniki | 54622 | Greece |
| EUROMEDICA General Clinic of Thessaloniki | Thessaloniki | 54645 | Greece |
| Papageorgiou General Hospital of Thessaloniki | Thessaloniki | 56429 | Greece |
| Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz | Székesfehérvár | 8000 | Hungary |
| Pulmonary Institute Torokbalint | Törökbálint | 2045 | Hungary |
| Beacon Hospital | Dublin | D18 AK68 | Ireland |
| St James Hospital | Dublin | Dublin 8 | Ireland |
| MidWestern Regional Hospital | Limerick | Ireland |
| Azienda Ospedaliero - Universitaria Policlinico - Vittorio Emanuele - Ospedale Gaspare Rodolico | Catania | 95123 | Italy |
| IRCCS AziendaOspedaliera Universitaria San Martino | Genova | 16132 | Italy |
| Istituto Scientifico Romagnolo Per Lo Studio e La Cura Dei Tumori (I.R.S.T.) | Meldola | 47014 | Italy |
| Universita Campus Bio-Medico di Roma | Roma | 00128 | Italy |
| Istituto Nazionale Tumori Regina Elena di Roma | Roma | 00144 | Italy |
| Osaka Prefectural Medical Center for Respiratory and Allergic Diseases | Habikino-shi | 583-8588 | Japan |
| Kansai Medical University Hospital | Hirakata-shi | 573-1191 | Japan |
| Hiroshima University Hospital | Hiroshima | 734-8551 | Japan |
| Kanazawa University Hospital | Kanazawa | Japan |
| Matsusaka Municipal Hospital | Matsusaka-shi | 515-8544 | Japan |
| Toranomon Hospital | Minatoku | 105-8470 | Japan |
| Iwate Medical University Hospital | Morioka | 020-8505 | Japan |
| National Hospital Organization - Nagoya Medical Center | Nagoya | 460-0001 | Japan |
| Nagoya University Hospital | Nagoya | 466-8560 | Japan |
| Niigata Cancer Center Hospital | Niigata | 951-8566 | Japan |
| Osaka City University Hospital | Osaka | 545-8586 | Japan |
| Gunma Prefectural Cancer Center | Ōta-ku | 373-8550 | Japan |
| Kitasato University Hospital | Sagamihara | 252-0375 | Japan |
| Sendai Kousei Hospital | Sendai | 980-0873 | Japan |
| Kanagawa Cardiovascular and Respiratory Center | Yokohama | 236-0051 | Japan |
| Yokohama Municipal Citizen's Hospital | Yokohama | 240-8555 | Japan |
| Vrije Universiteit Medisch Centrum (VUMC) | Amsterdam | 1081 HV | Netherlands |
| Gelre Hospitals | Zutphen | 7207 AE | Netherlands |
| Waikato Hospital | Hamilton | 3204 | New Zealand |
| Tauranga Hospital | Tauranga | 3112 | New Zealand |
| Centrum Onkologii im. prof. Franciszka Lukaszczyka w Bydgoszczy | Bydgoszcz | 85796 | Poland |
| Centrum Onkologii - Instytut im. Marii Sklodowskiej-Curie | Gliwice | 44-101 | Poland |
| Med Polonia Sp. z o.o. NSZOZ | Poznan | 60-693 | Poland |
| Centrum Onkologii-Instytut im.Marii Sklodowskiej-Curie | Warsaw | 02-781 | Poland |
| Hospital Prof. Doutor Fernando Fonseca | Amadora | 2720-276 | Portugal |
| Centro Hospitalar E Universitario de Coimbra EPE | Coimbra | 3000-075 | Portugal |
| Centro Hospitalar do Alto Ave, Hospital da Senhora da Oliveira Guimaraes | Guimarães | 4835-044 | Portugal |
| CUF Descobertas Hospital | Lisbon | 1998-018 | Portugal |
| Centro Hospitalar do Porto - Hospital de Santo António | Porto | 4099-001 | Portugal |
| CUF Porto Hospital | Porto | 4100-180 | Portugal |
| Instituto Portugues de Oncologia Do Porto Francisco Gentil Epe | Porto | 4200-072 | Portugal |
| Oncology Institute Professor Doctor Alexandru Trestioreanu | Bucharest | 022328 | Romania |
| Prof. Dr. I. Chiricuta Institute of Oncology | Cluj-Napoca | 400015 | Romania |
| Medisprof SRL | Cluj-Napoca | 400058 | Romania |
| Sf. Apostol Andrei Constanta Emergency Clinical County Hospital | Constanța | 900591 | Romania |
| Oncology Center Sfantul Nectarie | Craiova | Romania |
| Life Search SRL | Timișoara | 300167 | Romania |
| Oncocenter Clinical Oncology | Timișoara | 300210 | Romania |
| Principal Military Clinical Hospital n.a. N.N. Burdenko | Moscow | 105229 | Russia |
| Omsk Regional Oncology Center | Omsk | 610013 | Russia |
| Ryazan State Medical University n.a. I.P. Pavlov | Ryazan | 390026 | Russia |
| Clinical Hospital of the Russian Academy of Sciences | Saint Petersburg | 194017 | Russia |
| GBUZ Saint Petersburg Clinical Research Center of Specialized Types of Care (Oncology) | Saint Petersburg | 197758 | Russia |
| Research Oncology Institute of Rosmed Technologies n.a. prof. N.N. Petrov | Saint Petersburg | 197758 | Russia |
| Mordovia State University | Saransk | 43002 | Russia |
| National University Hospital | Singapore | 119074 | Singapore |
| Raffles Hospital | Singapore | 188770 | Singapore |
| Chungbuk National University Hospital | Cheongju-si | 138-736 | South Korea |
| Seoul National University Bundang Hospital | Seongnam-si | 13620 | South Korea |
| Asan Medical Center | Seoul | 5505 | South Korea |
| Ajou University Hospital | Suwon | 16499 | South Korea |
| Hospital Universitario a Coruna | A Coruña | 15006 | Spain |
| Hospital General Universitario de Alicante | Alicante | 03010 | Spain |
| Hospital Universitario Germans Trias i Pujol | Barcelona | 08916 | Spain |
| Insular-Maternal and Child University Hospital Complex | Las Palmas de Gran Canaria | 35016 | Spain |
| Hospital Universitario Fundacion Jimenez Diaz | Madrid | 28040 | Spain |
| Hospital Universitario 12 de Octubre | Madrid | 28041 | Spain |
| Hospital Universitario Puerta de Hierro-Majadahonda | Majadahonda, Madrid | 28222 | Spain |
| Hospital General Carlos Haya | Málaga | 29010 | Spain |
| Hospital Universitario Central de Asturias | Oviedo | 33011 | Spain |
| Hospital Universitari i Politecnic La Fe de Valencia | Valencia | 46026 | Spain |
| Buddhist Dalin Tzu Chi General Hospital | Dalin | 62247 | Taiwan |
| E-DA Hospital | Kaohsiung City | 82445 | Taiwan |
| Kaohsiung Medical University Hospital | Kaohsiung, San Ming Dist. | 807 | Taiwan |
| Chang Gung Medical Foundation, Kaohsiung Memorial Hospital | Niao-Sung Hsiang Kaohsiung County | 83301 | Taiwan |
| National Taiwan University Hospital | Taipei, Zhongzheng Dist. | 100 | Taiwan |
| University Hospitals Birmingham NHS Foundation Trust - Queen Elizabeth Hospital | Birmingham | B15 2TH | United Kingdom |
| East Suffolk and North Essex NHS Foundation Trust - Colchester Hospital | Colchester | CO4 5JL | United Kingdom |
| University College London Hospitals NHS Foundation Trust - University College Hospital | London | NW1 2BU | United Kingdom |
| Guys Hospital | London | SE1 9RT | United Kingdom |
| Royal Marsden Hospital | London | SW3 6JJ | United Kingdom |
| Maidstone and Tunbridge Wells NHS Trust - Maidstone Hospital | Maidstone | ME16 9QQ | United Kingdom |
| Manchester University NHS Foundation Trust - Wythenshawe Hospital - North West Lung Centre | Manchester | M23 9LT | United Kingdom |
| The Hillingdon Hospitals NHS Foundation Trust - Mount Vernon Hospital | Northwood | HA6 2RN | United Kingdom |
| Sheffield Teaching Hospitals NHS Foundation Trust - Weston Park Hospital | Sheffield South Yorkshire | S10 2SS | United Kingdom |
| Royal Cornwall Hospitals Trust | Truro | TR1 3LJ | United Kingdom |
| FG001 | Placebo + Concurrent Chemoradiotherapy -Tislelizumab | Participants were to receive 2 cycles of identically matching placebo by IV infusion Q 3 weeks with cCRT, followed by monotherapy with tislelizumab 200 mg IV Q 3W until disease progression, death, unacceptable toxicity, subject or physician decision, withdrawal of consent or treatment discontinuation for another reason. |
| FG002 | Placebo + Concurrent Chemoradiotherapy - Placebo | Participants were to receive 2 cycles of identically matching placebo by IV infusion Q 3 weeks with cCRT, followed by monotherapy with placebo IV Q 3W until disease progression, death, unacceptable toxicity, subject or physician decision, withdrawal of consent or treatment discontinuation for another reason. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Intent to Treat Population included all randomized participants regardless of whether the participant received any study drug or had any efficacy assessments performed.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Tislelizumab + Concurrent Chemoradiotherapy -Tislelizumab | Participants were to receive 2 cycles of tislelizumab 200 mg by intravenous (IV) infusion every 3 weeks (Q3W) with concurrent chemoradiotherapy (cCRT), followed by monotherapy with tislelizumab 200 mg IV Q3W until disease progression, death, unacceptable toxicity, subject or physician decision, withdrawal of consent or treatment discontinuation for another reason. |
| BG001 | Placebo + Concurrent Chemoradiotherapy -Tislelizumab | Participants were to receive 2 cycles of identically matching placebo by IV infusion Q 3 weeks with cCRT, followed by monotherapy with tislelizumab 200 mg IV Q 3W until disease progression, death, unacceptable toxicity, subject or physician decision, withdrawal of consent or treatment discontinuation for another reason. |
| BG002 | Placebo + Concurrent Chemoradiotherapy - Placebo | Participants were to receive 2 cycles of identically matching placebo by IV infusion Q 3 weeks with cCRT, followed by monotherapy with placebo IV Q 3W until disease progression, death, unacceptable toxicity, subject or physician decision, withdrawal of consent or treatment discontinuation for another reason. |
| 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, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Ethnicity (NIH/OMB) | 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) | Progression-free survival was defined as the time from the date of randomization to the date of the first objectively tumor progression as assessed by the blinded independent central review per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 criteria (documented by radiological assessment) or death (any cause) on or prior to the clinical cut-off date, which ever occurred first. Stable disease-neither sufficient shrinkage to qualify for PR nor sufficient increase of lesions to qualify for Progressive disease (PD)• Progressive Disease- At least a 20% increase in the sum of diameters of target lesions from nadir. | The study was terminated. The number of participants and the data collection period were not sufficient for statistical analysis. The patient withdrew consent. | Posted | Up to approximately 5 years; date of randomization to the date of tumor progression or death; until study withdrawal date of 26 June 2019 |
|
| |||||||||||||||||||||||||
| Secondary | Overall Survival (OS) | Overall survival was defined as the time between randomization of treatment and death from any cause. | The study was terminated. The number of participants and the data collection period were not sufficient for statistical analysis. The patient withdrew consent. | Posted | Up to approximately 5 years; date of randomization to date of death from any cause. |
| ||||||||||||||||||||||||||
| Secondary | Overall Survival at 24 Months | Overall survival was defined as the time between randomization of treatment and death from any cause. | The study was terminated. The number of participants and the data collection period were not sufficient for statistical analysis. The patient withdrew consent. | Posted | Up to approximately 24 months |
| ||||||||||||||||||||||||||
| Secondary | Percentage of Participants Who Achieved a Best Overall Response of Complete Response or Partial Response | Overall Response was defined as percentage of participants who had a radiologic confirmed complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1) guidelines, between Day 1 of treatment and subsequent anti-cancer therapy, death or study discontinuation. Complete response was defined as the disappearance of all target lesions; partial response (PR) is defined as at least a 30% decrease in the sum of diameters of target lesions from baseline; stable disease-neither sufficient shrinkage to qualify for PR nor sufficient increase of lesions to qualify for progressive disease (PD). | The study was terminated. The number of participants and the data collection period were not sufficient for statistical analysis. The patient withdrew consent. | Posted | Up to approximately 5 years |
| ||||||||||||||||||||||||||
| Secondary | Duration of Response | Duration of Response is defined as the time from the first occurrence of a documented objective response to the time of relapse, as determined by blinded independent central review per RECIST v1.1, or death from any cause, whichever comes first. | The study was terminated. The number of participants and the data collection period were not sufficient for statistical analysis. The patient withdrew consent. | Posted | Up to approximately 5 years |
| ||||||||||||||||||||||||||
| Secondary | Percentage of Participants Alive and Progression-Free at 12 Months (APF12) | Progression-free survival was defined as the time from the date of randomization to the date of the first objectively tumor progression as assessed by the blinded independent central review per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 criteria (documented by radiological assessment) or death (any cause) on or prior to the clinical cut-off date, which ever occurred first | The study was terminated. The number of participants and the data collection period were not sufficient for statistical analysis. The patient withdrew consent. | Posted | Up to 12 months |
| ||||||||||||||||||||||||||
| Secondary | Percentage of Participants Alive and Progression-free at 18 Months (APF18) | Progression-free survival was defined as the time from the date of randomization to the date of the first objectively tumor progression as assessed by the blinded independent central review per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 criteria (documented by radiological assessment) or death (any cause) on or prior to the clinical cut-off date, which ever occurred first | The study was terminated. The number of participants and the data collection period were not sufficient for statistical analysis. The patient withdrew consent. | Posted | Up to approximately 18 months |
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| Secondary | Time to Distant Metastasis (TTDM) | TTDM was defined as the time from the date of randomization until the first date of distant metastasis or death in the absence of distant metastasis. Distant metastasis was defined as any new lesion that is outside of the radiation field according to RECIST v1.1 or proven by biopsy. | The study was terminated. The number of participants and the data collection period were not sufficient for statistical analysis. The patient withdrew consent. | Posted | Up to approximately 5 years |
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| Secondary | Number of Participants With Treatment Emergent Adverse Events (TEAEs) | TEAEs include any adverse events (AEs) that had an onset date or a worsening in severity from baseline on or after the first dose of study drug up to 30 days following study drug discontinuation or initiation of new anticancer therapy, whichever occurred first. TEAEs also included all immune-related AEs recorded up to 90 days after the last dose of tislelizumab or placebo, regardless of whether or not the particpant started a new anticancer therapy. In addition, any serious AE with an onset date more than 30 days after the last dose of study drug that is assessed by the investigator as related to study drug were considered a TEAE." | Safety population includes participants who received at least 1 dose of study drug. | Posted | Number | Participants | From first dose of study drug up to study withdrawal date of 26 June 2019; 15 days. |
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| Secondary | Number of Participants With Lung Cancer Symptoms Assessed by the Corresponding Domains of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC-QLQ-C30) and Lung-Cancer Specific QLQ-LC13 | The EORTC QLQ-C30 is a 30-item, questionnaire assessing quality of life (QoL), psychosocial burden and physical symptoms. It is classified into 15 domains: 5 functional subscales (physical functioning, role functioning, emotional functioning, cognitive functioning, and social functioning); 3 multi-item symptom subscales (fatigue, nausea/vomiting, and pain); each item is measured on a 4 point response scale; (not at all, a little, quite a bit, very much), with the exception of the 2 items measuring global health and QoL, (measured on a 7-point response scale). Scores are linearly transformed to 0 to 100 scores. Scores vary from 0 (worst) to 100 (best) for the functional dimensions and GHS, and from 0 (best) to 100 (worst) for the symptom dimensions; higher scores = better QoL, better functioning, or more severe symptoms, respectively. The LC13 covers 13 typical symptoms of lung cancer patients, such as coughing, pain, dyspnea, sore mouth, peripheral neuropathy, and hair loss. | The study was terminated. The number of participants and the data collection period were not sufficient for statistical analysis. The patient withdrew consent. | Posted | Up to approximately 5 years |
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| Secondary | Percentage of Participants Who Would Have Continued on to Monotherapy Phase | Included the percentage of participants who would have received at least one dose of tislelizumab or placebo in the monotherapy phase before progression. | The study was terminated. The number of participants and the data collection period were not sufficient for statistical analysis. The patient withdrew consent. | Posted | Up to approximately 5 years |
|
From first dose of study drug up to study withdrawal date of 26 June 2019; 15 days.
No serious adverse events or deaths occurred during the course of the study,
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 + Concurrent Chemoradiotherapy -Tislelizumab | Participants were to receive 2 cycles of tislelizumab 200 mg by intravenous (IV) infusion every 3 weeks (Q3W) with concurrent chemoradiotherapy (cCRT), followed by monotherapy with tislelizumab 200 mg IV Q3W until disease progression, death, unacceptable toxicity, subject or physician decision, withdrawal of consent or treatment discontinuation for another reason. | 0 | 0 | 0 | 0 | 0 | 0 |
| EG001 | Placebo + Concurrent Chemoradiotherapy -Tislelizumab | Participants were to receive 2 cycles of identically matching placebo by IV infusion Q 3 weeks with cCRT, followed by monotherapy with tislelizumab 200 mg IV Q 3W until disease progression, death, unacceptable toxicity, subject or physician decision, withdrawal of consent or treatment discontinuation for another reason. | 0 | 1 | 0 | 1 | 1 | 1 |
| EG002 | Placebo + Concurrent Chemoradiotherapy - Placebo | Participants were to receive 2 cycles of identically matching placebo by IV infusion Q 3 weeks with cCRT, followed by monotherapy with placebo IV Q 3W until disease progression, death, unacceptable toxicity, subject or physician decision, withdrawal of consent or treatment discontinuation for another reason. | 0 | 0 | 0 | 0 | 0 | 0 |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Infusion Related Reaction | Injury, poisoning and procedural complications | MedDRA 21.0 | Systematic Assessment |
| |
| MUSCLE CRAMPING | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Systematic Assessment |
| |
| NECK PAIN | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Systematic Assessment |
|
Results from a center cannot be submitted for publication before results of multicenter study are published unless it is > 1 year since study completion. Then, Investigator can publish if manuscript is submitted to Celgene 60 days prior to submission. If Celgene decides publication would hinder drug development, Investigator must delay submission for up to 90 additional days. Investigator must delete confidential information before submission and defer publication to permit patent applications.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Anne McClain | Celgene Corporation | 908-673-9100 | ClinicalTrialDisclosure@Celgene.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 7, 2019 | Jun 26, 2020 | 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 |
| D059248 | Chemoradiotherapy |
| ID | Term |
|---|---|
| D003131 | Combined Modality Therapy |
| D013812 | Therapeutics |
| D004358 | Drug Therapy |
| D011878 | Radiotherapy |
Not provided
Not provided
| >=65 years |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
Participants were to receive 2 cycles of identically matching placebo by IV infusion Q 3 weeks with cCRT, followed by monotherapy with placebo IV Q 3W until disease progression, death, unacceptable toxicity, subject or physician decision, withdrawal of consent or treatment discontinuation for another reason. |
|
Participants were to receive 2 cycles of identically matching placebo by IV infusion Q 3 weeks with cCRT, followed by monotherapy with placebo IV Q 3W until disease progression, death, unacceptable toxicity, subject or physician decision, withdrawal of consent or treatment discontinuation for another reason.
|
| OG002 | Placebo + Concurrent Chemoradiotherapy - Placebo | Participants were to receive 2 cycles of identically matching placebo by IV infusion Q 3 weeks with cCRT, followed by monotherapy with placebo IV Q 3W until disease progression, death, unacceptable toxicity, subject or physician decision, withdrawal of consent or treatment discontinuation for another reason. |
|
Participants were to receive 2 cycles of identically matching placebo by IV infusion Q 3 weeks with cCRT, followed by monotherapy with placebo IV Q 3W until disease progression, death, unacceptable toxicity, subject or physician decision, withdrawal of consent or treatment discontinuation for another reason. |
|
| OG002 | Placebo + Concurrent Chemoradiotherapy - Placebo | Participants were to receive 2 cycles of identically matching placebo by IV infusion Q 3 weeks with cCRT, followed by monotherapy with placebo IV Q 3W until disease progression, death, unacceptable toxicity, subject or physician decision, withdrawal of consent or treatment discontinuation for another reason. |
|
| OG002 | Placebo + Concurrent Chemoradiotherapy - Placebo | Participants were to receive 2 cycles of identically matching placebo by IV infusion Q 3 weeks with cCRT, followed by monotherapy with placebo IV Q 3W until disease progression, death, unacceptable toxicity, subject or physician decision, withdrawal of consent or treatment discontinuation for another reason. |
|
| Placebo + Concurrent Chemoradiotherapy - Placebo |
Participants were to receive 2 cycles of identically matching placebo by IV infusion Q 3 weeks with cCRT, followed by monotherapy with placebo IV Q 3W until disease progression, death, unacceptable toxicity, subject or physician decision, withdrawal of consent or treatment discontinuation for another reason. |
|
| OG002 | Placebo + Concurrent Chemoradiotherapy - Placebo | Participants were to receive 2 cycles of identically matching placebo by IV infusion Q 3 weeks with cCRT, followed by monotherapy with placebo IV Q 3W until disease progression, death, unacceptable toxicity, subject or physician decision, withdrawal of consent or treatment discontinuation for another reason. |
|
|
| OG001 | Placebo + Concurrent Chemoradiotherapy -Tislelizumab | Participants were to receive 2 cycles of identically matching placebo by IV infusion Q 3 weeks with cCRT, followed by monotherapy with tislelizumab 200 mg IV Q 3W until disease progression, death, unacceptable toxicity, subject or physician decision, withdrawal of consent or treatment discontinuation for another reason. |
| OG002 | Placebo + Concurrent Chemoradiotherapy - Placebo | Participants were to receive 2 cycles of identically matching placebo by IV infusion Q 3 weeks with cCRT, followed by monotherapy with placebo IV Q 3W until disease progression, death, unacceptable toxicity, subject or physician decision, withdrawal of consent or treatment discontinuation for another reason. |
|
Participants were to receive 2 cycles of identically matching placebo by IV infusion Q 3 weeks with cCRT, followed by monotherapy with placebo IV Q 3W until disease progression, death, unacceptable toxicity, subject or physician decision, withdrawal of consent or treatment discontinuation for another reason. |
|