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| ID | Type | Description | Link |
|---|---|---|---|
| 2014-005060-15 | EudraCT Number |
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| Name | Class |
|---|---|
| Merck KGaA, Darmstadt, Germany | INDUSTRY |
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The main purpose of this study was to demonstrate superiority with regard to overall survival of avelumab versus docetaxel in participants with programmed death ligand 1 (PD-L1) positive, non-small cell lung cancer (NSCLC) after failure of a platinum-based doublet.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Avelumab | Experimental |
| |
| Docetaxel | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Avelumab | Drug | Participants received 10 milligrams per kilogram (mg/kg) of avelumab as a 1-hour intravenous infusion once every 2 weeks until confirmed disease progression, significant clinical deterioration, unacceptable toxicity, or any criterion for withdrawal from the study or Investigational Medicinal Product (IMP) as defined in the study protocol was fulfilled. |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS) Time in Programmed Death Ligand 1 (PD-L1) + Full Analysis Set Population (FAS) | The OS time was defined as the time from randomization to the date of death. The participants who were still alive at the time of data analysis or who were lost to follow-up OS time was censored at the last recorded date that the participant was known to be alive before the data cutoff date. OS was measured using Kaplan-Meier (KM) estimates. | Time from date of randomization up to 1420 days |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS) Time in Full Analysis Set Population | The OS time was defined as the time from randomization to the date of death. The participants who were still alive at the time of data analysis or who were lost to follow-up OS time was censored at the last recorded date that the participant was known to be alive before the data cutoff date. OS was measured using Kaplan-Meier (KM) estimates. |
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Inclusion Criteria
Signed written informed consent before any trial related procedure
Male or female participants aged greater than or equal to (>=) 18 years
Availability of a formalin-fixed, paraffin-embedded block containing tumor tissue or 7 unstained tumor slides suitable for PD-L1 expression assessment
Tumor determined to be evaluable for PD-L1 expression per the evaluation of a central laboratory
Participants with histologically confirmed Stage IIIb/IV or recurrent NSCLC who have experienced disease progression
Participants must have progressed after an acceptable therapy defined as follows:
Participants with non-squamous cell NSCLC of unknown epidermal growth factor receptor (EGFR) mutation status will require testing (local laboratory, or central laboratory if local testing is not available). Participants with a tumor that harbors an activating EGFR mutation will not be eligible
Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 to 1 at trial entry
Estimated life expectancy of more than 12 weeks
Adequate hematological function defined by White Blood Cell (WBC) count >= 2.5 × 10^9/L with absolute neutrophil count (ANC) >= 1.5 × 10^9/L, lymphocyte count >=0.5 × 10^9/L, platelet count >= 100 × 10^9/L, and hemoglobin >= 9 gram per deciliter (g/dL) (may have been transfused)
Adequate hepatic function defined by a total bilirubin level less than or equal to (<=) 1.5 × the upper limit of normal (ULN) range and aspartate aminotransferase (AST) and alanine aminotransferase (ALT) levels <= 2.5 × ULN for all participants
Adequate renal function defined by an estimated creatinine clearance > 30 milliliter per minute (mL/min) according to the Cockcroft-Gault formula (or local institutional standard method).
Other protocol defined inclusion criteria could apply
Exclusion criteria
In the United States only, participants with a squamous cell histology will be excluded
Systemic anticancer therapy administered after disease progression during or following a platinum based combination
Participants with non-squamous cell NSCLC whose disease harbors EGFR mutation(s) and/or anaplastic lymphoma kinase (ALK) rearrangement will not be eligible for this trial. Participants of unknown ALK and/or EGFR mutation status will require testing at screening (local laboratory, or central laboratory if local testing is not available)
Prior therapy with any antibody/drug targeting T cell coregulatory proteins (immune checkpoints) such as PD-1, PD L1, or cytotoxic T lymphocyte antigen-4 (CTLA-4).
Concurrent anticancer treatment
Major surgery for any reason, except diagnostic biopsy, within 4 weeks of randomization and/or if the participant has not fully recovered from the surgery within 4 weeks of randomization
Participants receiving immunosuppressive agents (such as steroids) for any reason should be tapered off these drugs before initiation of the trial treatment.
All participants with brain metastases, except those meeting the following criteria:
Active autoimmune disease that might deteriorate when receiving an immunostimulatory agent:
Previous or ongoing administration of systemic steroids for the management of an acute allergic phenomenon is acceptable as long as it is anticipated that the administration of steroids will be completed in 14 days, or that the daily dose after 14 days will be <=10 mg per day of equivalent prednisone
Other protocol defined exclusion criteria could apply
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| Name | Affiliation | Role |
|---|---|---|
| Medical Responsible | EMD Serono Inc., a business of Merck KGaA, Darmstadt, Germany | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama | Tuscaloosa | Alabama | 35401 | United States | ||
| Mayo Clinic |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35771392 | Derived | Coon CD, Schlichting M, Zhang X. Interpreting Within-Patient Changes on the EORTC QLQ-C30 and EORTC QLQ-LC13. Patient. 2022 Nov;15(6):691-702. doi: 10.1007/s40271-022-00584-w. Epub 2022 Jun 30. | |
| 35144482 | Derived | Hrinczenko B, Iannotti N, Goel S, Spigel D, Safran H, Taylor MH, Bennouna J, Wong DJ, Kelly K, Verschraegen C, Bajars M, Manitz J, Ruisi M, Gulley JL. Long-term avelumab in advanced non-small-cell lung cancer: summaries and post hoc analyses from JAVELIN Solid Tumor. Future Oncol. 2022 Apr;18(11):1333-1342. doi: 10.2217/fon-2021-0930. Epub 2022 Feb 11. |
| Label | URL |
|---|---|
| Trial Awareness and Transparency website | View source |
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Per company policy, following approval of a new product or a new indication for an approved product in both the EU and the US, EMD Serono will share study protocols, anonymized patient level and study level data and redacted clinical study reports from clinical trials in patients with qualified scientific and medical researchers, upon request, as necessary for conducting legitimate research. Further information on how to request data can be found on our website https://www.emdgroup.com/en/research/our-approach-to-research-and-development/healthcare/clinical-trials/commitment-responsible-data-sharing.html
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First participant signed informed consent: 24 Mar 2015, Clinical data cut-off: 04 March 2019.
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| ID | Title | Description |
|---|---|---|
| FG000 | Avelumab | Participants received 10 milligrams per kilogram (mg/kg) of avelumab as a 1-hour intravenous infusion once every 2 weeks until confirmed disease progression, significant clinical deterioration, unacceptable toxicity, or any criterion for withdrawal from the study or Investigational Medicinal Product (IMP) as defined in the study protocol was fulfilled. |
| 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 |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | Dec 11, 2017 | Nov 19, 2018 |
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| Docetaxel | Drug | Participants received 75 mg per square meter (m^2) (per label) of docetaxel by intravenous infusion once every 3 weeks until confirmed disease progression, significant clinical deterioration, unacceptable toxicity, or any criterion for withdrawal from the study or Investigational Medicinal Product (IMP) as defined in the study protocol was fulfilled. |
|
| Time from date of randomization up to 1420 days |
| Progression-Free Survival (PFS) Time in PD-L1+ Full Analysis Set Population | PFS was defined as the time from date of randomization until date of the first documentation of progressive disease (PD) or death due to any cause in the absence of documented PD, whichever occurs first. PFS was assessed as per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) as adjudicated by independent endpoint review committee (IERC). PD was defined as at least a 20 percent (%) increase in the sum of longest diameter (SLD), taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions and unequivocal progression of non-target lesions. PFS was measured using Kaplan-Meier (KM) estimates. | Time from date of randomization up to 907 days |
| Progression-Free Survival (PFS) Time in Full Analysis Set Population | PFS was defined as the time from date of randomization until date of the first documentation of progressive disease (PD) or death due to any cause in the absence of documented PD, whichever occurs first. PFS was assessed as per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) as adjudicated by independent endpoint review committee (IERC). PD was defined as at least a 20 percent (%) increase in the sum of longest diameter (SLD), taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions and unequivocal progression of non-target lesions. PFS was measured using Kaplan-Meier (KM) estimates. | Time from date of randomization up to 907 days |
| Number of Participants With Confirmed Best Overall Response (BOR) as Assessed by an Independent Endpoint Review Committee (IERC) in Full Analysis Set Population | Confirmed BOR was determined according to RECIST v1.1 and as adjudicated by an IERC. Confirmed BOR was defined as the best response of any of the complete response (CR), partial response (PR), stable disease (SD) and progressive disease (PD) recorded from the date of randomization until disease progression or recurrence (taking the smallest measurement recorded since the start of treatment as reference). CR: Disappearance of all evidence of target and non-target lesions. PR: At least 30% reduction from baseline in the sum of the longest diameter (SLD) of all lesions. SD: Neither sufficient increase to qualify for PD nor sufficient shrinkage to qualify for PR. PD was defined as at least a 20% increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions and unequivocal progression of non-target lesions. Number of participants with best overall response in each category (CR, PR, SD, PD) was reported. | Time from date of randomization up to 907 days |
| Number of Participants With Confirmed Best Overall Response (BOR) as Assessed by Independent Endpoint Review Committee (IERC) in PD-L1+ Full Analysis Set Population | Confirmed BOR was determined according to RECIST v1.1 and as adjudicated by an IERC. Confirmed BOR was defined as the best response of any of the complete response (CR), partial response (PR), stable disease (SD) and progressive disease (PD) recorded from the date of randomization until disease progression or recurrence (taking the smallest measurement recorded since the start of treatment as reference). CR: Disappearance of all evidence of target and non-target lesions. PR: At least 30% reduction from baseline in the sum of the longest diameter (SLD) of all lesions. SD: Neither sufficient increase to qualify for PD nor sufficient shrinkage to qualify for PR. PD was defined as at least a 20% increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions and unequivocal progression of non-target lesions. Number of participants with best overall response in each category (CR, PR, SD, PD) was reported. | Time from date of randomization up to 907 days |
| Percentage of Participants With Objective Response as Assessed by Independent Endpoint Review Committee (IERC) in Full Analysis Set Population | Percentage of participants with objective response (CR plus PR) according to RECIST v1.1 was reported. CR: Disappearance of all evidence of target and non-target lesions. PR: At least 30% reduction from baseline in the sum of the longest diameter (SLD) of all lesions. | Time from date of randomization up to 907 days |
| Percentage of Participants With Objective Response as Assessed by Independent Endpoint Review Committee (IERC) in PD-L1+ Full Analysis Set Population | Percentage of participants with objective response (CR plus PR) according to RECIST v1.1 was reported. CR: Disappearance of all evidence of target and non-target lesions. PR: At least 30% reduction from baseline in the sum of the longest diameter (SLD) of all lesions. | Time from date of randomization up to 907 days |
| Change From Baseline in European Quality of Life 5-dimensions (EQ-5D-5L) Health Outcome Questionnaire Through Composite Index Score at End of Treatment (EOT) | The EQ-5D-5L health outcome questionnaire was a measure of health status that provides a simple descriptive profile and a single index value. The EQ-5D-5L defined health in terms of mobility, self-care, usual activities, pain/discomfort and anxiety/depression. The 5 items were combined to generate health profiles. These profiles were converted to a continuous single index score. The lowest possible score was -0.59 (unable to walk, unable to self-care, unable to do usual activities, extreme pain or discomfort, extreme anxiety or depression) and the highest was 1.00 (no problems in all 5 dimensions). | Baseline, End of treatment visit (up to Week 124) |
| Change From Baseline in European Quality of Life 5-dimensions (EQ-5D-5L) Health Outcome Questionnaire Through Visual Analogue Scale (VAS) at End of Treatment (EOT) | EQ-5D-5L was comprised of the following 5 participant-reported dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension had 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. The responses were used to derive overall score using a visual analog scale (VAS) that ranged from 0 to 100 millimeter (mm), where 0 was the worst health you can imagine and 100 was the best health you can imagine. | Baseline, End of treatment visit (up to Week 124) |
| Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life (EORTC QLQ-C30) Global Health Status at End of Treatment (EOT) | EORTC QLQ-C30 was a 30-question tool used to assess the overall quality of life (QoL) in cancer participants. It consisted of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, role, cognitive, emotional, social), and 9 symptom scales/items (Fatigue, nausea and vomiting, pain, dyspnea, sleep disturbance, appetite loss, constipation, diarrhea, financial impact). The EORTC QLQ-C30 GHS/QoL score ranged from 0 to 100; High score indicated better GHS/QoL. Score 0 represents: very poor physical condition and QoL. Score 100 represents: excellent overall physical condition and QoL. | Baseline, End of treatment visit (up to Week 124) |
| Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13) at End of Treatment (EOT) | EORTC QLQ-LC13 consisted of 13 questions relating to disease symptoms specific to lung cancer and treatment side effects typical of treatment with chemotherapy and radiotherapy. The EORTC QLQ-LC13 module generated one multiple-item score assessing dyspnea and a series of single item scores assessing coughing, hemoptysis, sore mouth, dysphagia, neuropathy, alopecia, pain in chest, pain in arms or shoulder and pain in other parts. Score range: 0 (no burden of symptom domain or single symptom item) to 100 (highest burden of symptoms for symptom domains and single items). | Baseline, End of treatment visit (up to Week 124) |
| Number of Participants With Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), Drug Related Treatment Emergent Adverse Events and Treatment Emergent Adverse Events Leading to Death | An Adverse event (AE) was defined as any unfavorable and unintended sign (including clinically significant abnormal laboratory, vital signs and 12-lead Electrocardiogram findings), symptom, or disease temporally associated with the use of study drug or worsening of pre-existing medical condition, whether or not related to study drug. A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect or was otherwise considered medically important. Treatment-emergent events were the events between first dose of study drug that were absent before treatment or that worsened relative to pre-treatment state up to 30 days after last administration. TEAEs included both Serious TEAEs and non-serious TEAEs. | Time from date of randomization up to 1420 days |
| Number of Participants With Treatment Emergent Adverse Events (TEAEs) by Severity | Treatment Emergent Adverse Events were graded as per National Cancer Institute Common Terminology Criteria for Adverse Experience version 4.03 (NCI-CTCAE v 4.03). Grade 3 refers to severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care and Activity of daily living (ADL), Grade 4 refers to Life-threatening consequences; where urgent intervention indicated, Grade 5 refers to the death related to adverse event. | Time from date of randomization up to 1420 days |
| Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance: Baseline Score vs. Worst Post-baseline Score | ECOG performance status measured to assess participant's performance status on a scale of 0 to 5, where 0 = Fully active, able to carry on all pre-disease activities without restriction; 1 = Restricted in physically strenuous activity, ambulatory and able to carry out light or sedentary work; 2 = Ambulatory and capable of all selfcare but unable to carry out any work activities; 3 = Capable of only limited self-care, confined to bed/chair for more than 50 percent of waking hours; 4 = Completely disabled, cannot carry on any self-care, totally confined to bed/chair; 5 = dead. The participants with missing worst post baseline score were also reported. ECOG performance status was reported in terms of number of participants with Baseline value vs. worst post-baseline value (i.e. highest score) combination. | Time from date of randomization up to 1420 days |
| Number of Participants With Positive Anti-Drug Antibodies (ADAs) and Neutralizing Antibodies (NAbs) for Avelumab | Serum samples were analyzed by a validated electrochemiluminesce immunoassay to detect the presence of antidrug antibodies (ADA). Samples that screened positive were subsequently tested in a confirmatory assay were tested for neutralizing antibodies (nAb). Number of participants with ADA or nAb positive results for Avelumab were reported. | Time from date of randomization up to 1420 days |
| Scottsdale , Phoenix |
| Arizona |
| 85259-5499 |
| United States |
| Pacific Cancer Medical Center, Inc. | Anaheim | California | 92801 | United States |
| Healing Hands Oncology and Medical Care | Lawndale | California | 90260 | United States |
| Sutter Gould Medical Foundation | Modesto | California | 95355 | United States |
| Sharp Memorial Hospital | San Diego | California | 92123 | United States |
| Lynn Cancer Institute Center | Boca Raton | Florida | 33486 | United States |
| University Cancer Institute | Boynton Beach | Florida | 33426 | United States |
| Holy Cross Hospital Inc. | Fort Lauderdale | Florida | 33308 | United States |
| Florida Cancer Specialists-Broadway | Fort Myers | Florida | 33916 | United States |
| Florida Cancer Specialists | St. Petersburg | Florida | 33705 | United States |
| Florida Cancer Specialists | West Palm Beach | Florida | 33401 | United States |
| Northeast Georgia Cancer Care, LLC | Athens | Georgia | 30607 | United States |
| Metairie Oncologist, LLC | Metairie | Louisiana | 70006 | United States |
| Henry Ford Health System | Detroit | Michigan | 48202 | United States |
| Hematology Oncology Associates of Rockland | Nyack | New York | 10960 | United States |
| Novant Health Oncology Specialists | Winston-Salem | North Carolina | 27103 | United States |
| Oncology Hematology Care | Cincinnati | Ohio | 45242 | United States |
| Signal Point Clinical Research Center | Middletown | Ohio | 45042 | United States |
| Mercy Clinic Oklahoma Communities, Inc. | Oklahoma City | Oklahoma | 73120-9309 | United States |
| Abington Memorial Hospital | Abington | Pennsylvania | 19001 | United States |
| Penn State Univ. Milton S. Hershey Medical Center | Hershey | Pennsylvania | 17033 | United States |
| Center for Biomedical Research, LLC | Knoxville | Tennessee | 37909 | United States |
| SCRI - Tennessee Oncology | Nashville | Tennessee | 37203 | United States |
| The Center for Cancer and Blood Disorders | Fort Worth | Texas | 76104 | United States |
| University of Texas Health Science Center at Tyler | Tyler | Texas | 75708 | United States |
| MultiCare Health System | Tacoma | Washington | 98405 | United States |
| Hospital Italiano Regional del Sur | Bahía Blanca | B8001HXM | Argentina |
| Clínica Universitaria Privada Reina Fabiola | Barrio General Paz | X5004FHP | Argentina |
| Centro de Oncologia e Investigacion Buenos Aires | Berazategui | B1880BBF | Argentina |
| Instituto Medico Especializado Alexander Fleming | Ciudad Autonoma Buenos Aires | C1426ANZ | Argentina |
| CEMIC | Ciudad Autonoma Buenos Aires | C1431FWO | Argentina |
| Instituto DAMIC Fundacion Rusculleda | Córdoba | X5003DCE | Argentina |
| Centro Oncologico Riojano Integral (Cori) | La Rioja | F5300COE | Argentina |
| Centro Oncologico de Parana | Paraná | 3100 | Argentina |
| Hospital Universitario Austral | Pilar | B1629ODT | Argentina |
| Instituto Gamma | Rosario | S2000CRF | Argentina |
| Sanatorio Parque S.A. | Rosario | S2000DSV | Argentina |
| Instituto de Oncología de Rosario | Rosario | S2000KZE | Argentina |
| Centro Medico San Roque S.R.L. | San Miguel de Tucumán | 4000 | Argentina |
| Ballarat Base Hospital | Ballarat | 3350 | Australia |
| Box Hill Hospital | Box Hill | 3128 | Australia |
| Coffs Harbour Base Hospital | Coffs Harbour | 2450 | Australia |
| Lyell McEwin Hospital | Elizabeth Vale | 5112 | Australia |
| Greenslopes Private Hospital | Greenslopes | 4120 | Australia |
| Lismore Base Hospital | Lismore | 2480 | Australia |
| Royal Melbourne Hospital | Parkville | 3050 | Australia |
| St John of God Hospital | Subiaco | 6008 | Australia |
| Princess Alexandra Hospital | Woolloongabba | 4102 | Australia |
| UZ Antwerpen | Edegem | 2650 | Belgium |
| Grand Hôpital de Charleroi | Gilly | 6060 | Belgium |
| UZ Leuven | Leuven | 3000 | Belgium |
| Centre Hospitalier de l'Ardenne | Libramont | 6800 | Belgium |
| C. H. U. Sart Tilman | Liège | 4000 | Belgium |
| AZ Delta | Roeselare | 8800 | Belgium |
| Cenantron - Centro Avançado de Tratamento Oncológico S/C Ltda | Belo Horizonte | 30110-921 | Brazil |
| CEPON - Centro de Pesquisas Oncológicas de Santa Catarina | Florianópolis | 88034-000 | Brazil |
| Hospital de Caridade de Ijuí | Ijuí | 98700-000 | Brazil |
| Clínica de Neoplasias Litoral Ltda. | Itajaí | 88310-110 | Brazil |
| CMiP - Centro Mineiro de Pesquisa | Juiz de Fora | 36010-570 | Brazil |
| Hospital Bruno Born | Lajeado | 95900-000 | Brazil |
| Liga Norte-Rio-Grandense Contra o Câncer | Natal | 59075-740 | Brazil |
| Oncosinos - Clínica de Oncologia - Hospital Regina | Novo Hamburgo | 93510-250 | Brazil |
| CITO - Centro Integrado de Terapia Onco-Hematológica - Hospital da Cidade de Passo Fundo | Passo Fundo | 99010-260 | Brazil |
| Hospital Mãe de Deus | Porto Alegre | 90110-270 | Brazil |
| Hospital São Lucas da PUCRS | Porto Alegre | 90610-000 | Brazil |
| COI - Clínicas Oncológicas Integradas | Rio de Janeiro | 22793-080 | Brazil |
| CEPHO - Centro de Estudos e Pesquisas em Hematologia e Oncologia | Santo André | 09060-650 | Brazil |
| Fundação Faculdade Regional de Medicina de São José do Rio Preto | São José do Rio Preto | 15090-000 | Brazil |
| ICESP - Instituto do Câncer do Estado de São Paulo Octavio Frias de Oliveira | São Paulo | 01246-000 | Brazil |
| IOS - Instituto de Oncologia de Sorocaba "Dr. Gilson Delgado" | Sorocaba | 18030-075 | Brazil |
| UMHAT 'Dr. Georgi Stranski', EAD | Pleven | 5800 | Bulgaria |
| Complex Oncological Center - Plovdiv, EOOD | Plovdiv | 4004 | Bulgaria |
| MHAT "Serdika", EOOD | Sofia | 1303 | Bulgaria |
| MHAT 'Tokuda Hospital Sofia', AD | Sofia | 1407 | Bulgaria |
| Shato, Ead | Sofia | 1756 | Bulgaria |
| MHAT 'Sv. Marina', EAD | Varna | 9010 | Bulgaria |
| Instituto de Terapias Oncologicas Providencia | Santiago | 7500000 | Chile |
| FALP - Fundación Arturo López Pérez | Santiago | 7500921 | Chile |
| CIEC - Centro Internacional de Estudios Clínicos | Santiago | 8420383 | Chile |
| Instituto Clinico Oncologico del Sur (ICOS) | Temuco | Chile |
| Centro de Investigaciones Clinicas Viña del Mar | Viña del Mar | 2540364 | Chile |
| Hospital Clinico Viña del Mar | Viña del Mar | Chile |
| Fundacion Cardioinfantil Instituto de Cardiologia | Bogotá | 110131 | Colombia |
| Instituto Nacional de Cancerologia E.S.E. | Bogotá | 111511 | Colombia |
| Administradora Country S.A. | Bogotá | Colombia |
| Clinica Colsanitas S.A. sede Clinica Universitaria Colombia | Bogotá | Colombia |
| Fundación Valle del Lilí | Cali | 760032 | Colombia |
| Centro Medico Imbanaco | Cali | 760042 | Colombia |
| Hemato Oncologos S.A. | Cali | Colombia |
| Hospital Pablo Tobón Uribe | Medellín | 050034 | Colombia |
| Instituto de Cancerologia S.A. | Medellín | Colombia |
| IPS IMAT- Instituto Medico de Alta Tecnologia - Oncomedica S.A. | Montería | Colombia |
| General Hospital Dubrovnik | Dubrovnik | 20000 | Croatia |
| General Hospital Zadar | Zadar | 23000 | Croatia |
| Clinical Hospital Centar "Sestre Milosrdnice" | Zagreb | 10000 | Croatia |
| University Clinic for Pulmonary Diseases | Zagreb | 10000 | Croatia |
| Masarykuv onkologicky ustav | Brno | 65653 | Czechia |
| Nemocnice Novy Jicin a.s. | Nový Jičín | 74101 | Czechia |
| Multiscan s.r.o. | Pardubice | 53203 | Czechia |
| Vseobecna fakultni nemocnice V Praze | Prague | 12808 | Czechia |
| Thomayerova nemocnice | Prague | 14059 | Czechia |
| Herlev Hospital | Herlev | 2730 | Denmark |
| Odense Universitetshospital | Odense C | 5000 | Denmark |
| ICO - Site Paul Papin | Angers | 49933 | France |
| CHU Besançon - Hôpital Jean Minjoz | Besançon | 25030 | France |
| Clinique Victor Hugo - Centre Jean Bernard | Le Mans | 72000 | France |
| Hôpital Nord - AP-HM Marseille# | Marseille | 13915 | France |
| Centre Catherine de Sienne | Nantes | 44202 | France |
| Centre Antoine Lacassagne | Nice | 06189 | France |
| Groupe Hospitalier Sud - Hôpital Haut-Lévêque | Pessac | 33604 | France |
| CHU Poitiers - Hôpital la Milétrie | Poitiers | 86021 | France |
| ICO - Site René Gauducheau | Saint-Herblain | 44805 | France |
| CHU Strasbourg - Nouvel Hôpital Civil | Strasbourg | 67091 | France |
| CHU de Toulouse - Hôpital Larrey | Toulouse | 31059 | France |
| Semmelweis Egyetem AOK | Budapest | 1125 | Hungary |
| Uzsoki Utcai Korhaz | Budapest | 1145 | Hungary |
| Petz Aladar Megyei Oktato Korhaz | Győr | 9024 | Hungary |
| Miskolci Semmelweis Korhaz es Egyetemi Oktatokorhaz | Miskolc | 3529 | Hungary |
| Tudogyogyintezet Torokbalint | Törökbálint | 2045 | Hungary |
| Assaf Harofeh Medical Center | Beer Yaakov | 70300 | Israel |
| Soroka Medical Center | Beersheba | 84101 | Israel |
| Rambam Health Care Campus | Haifa | 3109601 | Israel |
| The Lady Davis Carmel Medical Center | Haifa | 34361 | Israel |
| Hadassah University Hospital - Ein Kerem | Jerusalem | 9112001 | Israel |
| Sapir Medical Center, Meir Hospital | Kfar Saba | 4428164 | Israel |
| Rabin Medical Center-Beilinson Campus | Petah Tikva | 4941492 | Israel |
| Chaim Sheba Medical Center | Ramat Gan | 52621 | Israel |
| Tel Aviv Sourasky Medical Center | Tel Aviv | 64239 | Israel |
| Azienda Ospedaliera Istituti Ospitalieri di Cremona | Cremona | 26100 | Italy |
| Ospedale Mater Salutis | Legnago (VR) | 37045 | Italy |
| Ospedale Versilia | Lido di Camaiore | 55043 | Italy |
| Fondazione IRCCS Istituto Nazionale dei Tumori | Milan | 20133 | Italy |
| IEO Istituto Europeo di Oncologia | Milan | 20141 | Italy |
| Seconda Università degli Studi di Napoli | Naples | 80131 | Italy |
| Azienda Ospedaliero Universitaria Pisana | Pisa | 56124 | Italy |
| Università Campus Bio-Medico di Roma | Roma | 00128 | Italy |
| Istituto Nazionale Tumori Regina Elena IRCCS | Roma | 00144 | Italy |
| Policlinico Universitario Agostino Gemelli | Roma | 00168 | Italy |
| Azienda Ospedaliera Sant'Andrea-Università di Roma La Sapienza | Roma | 00189 | Italy |
| A.O.U. Senese Policlinico Santa Maria alle Scotte | Siena | 53100 | Italy |
| Azienda Ospedaliera Ospedale Treviglio-Caravaggio di Treviglio | Treviglio | 24047 | Italy |
| National Cancer Center Hospital | Chūōku | 104-0045 | Japan |
| NHO Kyushu Cancer Center | Fukuoka | 811-1395 | Japan |
| Osaka Prefectural Medical Center for Respiratory and Allergic Diseases | Habikino-shi | 583-8588 | Japan |
| Hiroshima City Hiroshima Citizens Hospital | Hiroshima | 730-8518 | Japan |
| National Cancer Center Hospital East | Kashiwa-shi | 277-8577 | Japan |
| Saitama Cancer Center | Kitaadachi-gun | 362-0806 | Japan |
| Institute of Biomedical Research and Innovation Hospital | Kobe | 650-0047 | Japan |
| Kobe City Hospital Organization Kobe City Medical Center General Hospital | Kobe | 650-0047 | Japan |
| Cancer Institute Hospital of JFCR | Kōtoku | 135-8550 | Japan |
| Kurume University Hospital | Kurume-shi | 830-0011 | Japan |
| Miyagi Cancer Center | Natori-shi | 981-1293 | Japan |
| Aichi Cancer Center Hospital | Okazaki-shi | 444-0011 | Japan |
| Osaka City General Hospital | Osaka | 534-0021 | Japan |
| Osaka Medical Center for Cancer and Cardiovascular Diseases | Osaka | 537-8511 | Japan |
| Kinki University Hospital | Osakasayama-shi | 589-8511 | Japan |
| Kitasato University Hospital | Sagamihara-shi | 252-0375 | Japan |
| NHO Hokkaido Cancer Center | Sapporo | 003-0804 | Japan |
| Hokkaido University Hospital | Sapporo | 060-8648 | Japan |
| Tokyo Medical University Hospital | Shinjuku-ku | 160-0023 | Japan |
| Toyama University Hospital | Toyama | 930-0194 | Japan |
| Wakayama Medical University Hospital | Wakayama | 641-8510 | Japan |
| Yokohama Municipal Citizen's Hospital | Yokohama | 240-8555 | Japan |
| Kanagawa Cancer Center | Yokohama | 241-8515 | Japan |
| Phylasis Clinicas Research S de RL de CV | Cuautitlán Izcalli | 54769 | Mexico |
| Instituto de Investigaciones Aplicadas a la Neurociencia A.C. | Durango | 34000 | Mexico |
| Fundacion Rodolfo Padilla Padilla, A.C. | León | 37000 | Mexico |
| Health Pharma Professional Research S.A. de C.V. | México | 03810 | Mexico |
| Winsett Rethman S.A. de C.V. | Monterrey | 64060 | Mexico |
| Centro de Investigacion Clinica Chapultepec S.A. de C.V. | Morelia | 58260 | Mexico |
| Oaxaca Site Management Organization S.C. | Oaxaca City | 68000 | Mexico |
| Centro Oncologico Estatal ISSEMyM | Toluca | 50180 | Mexico |
| Clinica Monte Carmelo | Arequipa | 04000 | Peru |
| Hospital Nacional Almanzor Aguinaga Asenjo | Chiclayo | 14001 | Peru |
| Hospital Nacional Adolfo Guevara Velasco | Cusco | Peru |
| Clinica San Borja | Lima | 15000 | Peru |
| Hospital Nacional Guillermo Almenara Irigoyen | Lima | Lima 13 | Peru |
| Clínica Ricardo Palma | Lima | LIMA 27 | Peru |
| Instituto Nacional de Enfermedades Neoplásicas | Lima | LIMA 34 | Peru |
| Szpital Specjalistyczny W Brzozowie, Podkarpacki Osrodek Onkologiczny Im.Ks.B.Markiewicza | Brzozów | 36-200 | Poland |
| Wojewodzkie Centrum Szpitalne Kotliny Jeleniogorskiej | Jelenia Góra | 58-506 | Poland |
| Samodzielny Publiczny Szpital Kliniczny nr 5 SUM | Katowice | 40-514 | Poland |
| Centrum Terapii Wspolczesnej J.M. Jasnorzewska sp. komandytowo-akcyjna | Lodz | 90-242 | Poland |
| KO-MED Centra Kliniczne Lublin II | Lublin | 20-362 | Poland |
| SSZZOZ im. Dr Teodora Dunina w Rudce | Mrozy | 05-320 | Poland |
| Mazowieckie Centrum Leczenia Chorob Pluc i Gruzlicy | Otwock | 05-400 | Poland |
| Spitalul Judetean de Urgenta Alba Iulia | Alba Iulia | 510077 | Romania |
| Spitalul Judetean de Urgenta "Dr. Constantin Opris" Baia Mare | Baia Mare | 430031 | Romania |
| Policlinica de Diagnostic Rapid SRL | Brasov | 500152 | Romania |
| Spitalul Clinic Municipal "Dr. Gavril Curteanu" Oradea | Oradea | 410469 | Romania |
| Spital Lotus SRL | Ploieşti | 100011 | Romania |
| S.C Oncocenter Oncologie Clinica S.R.L | Timișoara | 300210 | Romania |
| SHI "Republican Clinical Oncological Dispensary of HM RT" | Kazan' | 420029 | Russia |
| SHBI Moscow Clinical Scientific Center of Department of Healthcare of Moscow | Moscow | 111123 | Russia |
| FSBHI Clinical research institute of phthisiopulmonology | Saint Petersburg | 191036 | Russia |
| Pavlov First Saint Petersburg State Medical University | Saint Petersburg | 197022 | Russia |
| St. Petersburg SHI "City Clinical Oncology Dispensary" | Saint Petersburg | 197022 | Russia |
| FBI "Scientific Research Institute of Oncology n. a. N. N. Petrov" | Saint Petersburg | 197758 | Russia |
| Nemocnica s poliklinikou Sv. Jakuba, n.o. Bardejov | Bardejov | 08501 | Slovakia |
| Univerzitna nemocnica Bratislava, Nemocnica Ruzinov | Bratislava | 82606 | Slovakia |
| Ustredna vojenska nemocnica SNP Ruzomberok- Fakultna nemocnica | Ružomberok | 03426 | Slovakia |
| Fakultna nemocnica Trnava | Trnava | 91708 | Slovakia |
| GVI Cape Gate Oncology Centre | Cape Town | 7570 | South Africa |
| GVI Rondebosch Oncology Centre | Cape Town | 7700 | South Africa |
| GVI Langenhoven Drive Oncology Centre | Port Elizabeth | 6045 | South Africa |
| University of Pretoria Oncology Department | Pretoria | 0002 | South Africa |
| Mary Potter Oncology Centre | Pretoria | 0181 | South Africa |
| Chungbuk National University Hospital | Cheongju-si | 28644 | South Korea |
| Chonnam National University Hwasun Hospital | Hwasun-gun | 519-763 | South Korea |
| Gachon University Gil Medical Center | Incheon | 21565 | South Korea |
| Seoul National University Bundang Hospital | Seongnam-si | 13620 | South Korea |
| Asan Medical Center | Seoul | 05505 | South Korea |
| Samsung Medical Center | Seoul | 06351 | South Korea |
| Korea University Guro Hospital | Seoul | 08308 | South Korea |
| Korea University Anam Hospital | Seoul | 136-705 | South Korea |
| The Catholic University of Korea, Seoul St. Mary's Hospital | Seoul | 137-701 | South Korea |
| The Catholic University of Korea, St. Vincent's Hospital | Suwon | 16247 | South Korea |
| Hospital General Universitario de Alicante | Alicante | 03010 | Spain |
| ICO Badalona - Hospital Germans Trias i Pujol | Badalona | 08916 | Spain |
| Hospital Universitari Quiron Dexeus | Barcelona | 08028 | Spain |
| Hospital Universitari Vall d'Hebron | Barcelona | 08035 | Spain |
| Hospital Clinic i Provincial de Barcelona | Barcelona | 08036 | Spain |
| ICO l´Hospitalet - Hospital Duran i Reynals | L'Hospitalet de Llobregat | 08908 | Spain |
| Hospital Universitario Materno-Infantil de Canarias | Las Palmas de Gran Canaria | 35016 | Spain |
| Hospital Universitario Ramon y Cajal | Madrid | 28034 | Spain |
| Centro Integral Oncologico Clara Campal | Madrid | 28050 | Spain |
| Hospital de Mataro | Mataró | 08304 | Spain |
| Hospital Clinico Universitario Virgen de la Victoria | Málaga | 29010 | Spain |
| Complejo Hospitalario Universitario de Santiago | Santiago de Compostela | 15706 | Spain |
| Hospital Universitario Virgen Macarena | Seville | 41009 | Spain |
| Hospital Universitario Virgen del Rocio | Seville | 41013 | Spain |
| Hospital Universitari i Politecnic La Fe | Valencia | 46026 | Spain |
| Kantonsspital Graubuenden | Chur | 7000 | Switzerland |
| Taichung Veterans General Hospital | Taichung | 40705 | Taiwan |
| National Cheng Kung University Hospital | Tainan | 704 | Taiwan |
| National Taiwan University Hospital | Taipei | 100 | Taiwan |
| Taipei Veterans General Hospital | Taipei | 112 | Taiwan |
| Tri-Service General Hospital | Taipei | 11490 | Taiwan |
| Chang Gung Memorial Hospital, Linkou | Taoyuan County | 333 | Taiwan |
| Hacettepe University Medical Faculty | Ankara | 06100 | Turkey (Türkiye) |
| Baskent University Ankara Hospital | Ankara | 06500 | Turkey (Türkiye) |
| Ankara University Medical Faculty | Ankara | Turkey (Türkiye) |
| Trakya University Medical Faculty | Edirne | 22030 | Turkey (Türkiye) |
| Bezmi Alem Foundation University Medical Faculty Hospital | Istanbul | 34093 | Turkey (Türkiye) |
| Istanbul University Cerrahpasa Medical Faculty | Istanbul | 34098 | Turkey (Türkiye) |
| Fatih Universitesi Tip Fakultesi | Istanbul | 34500 | Turkey (Türkiye) |
| Marmara University Pendik Research and Training Center | Istanbul | 34899 | Turkey (Türkiye) |
| Ege University Medical Faculty | Izmir | 35100 | Turkey (Türkiye) |
| Dokuz Eylul University Medicine Faculty | Izmir | 35340 | Turkey (Türkiye) |
| Konya Necmettin Erbakan University Meram Faculty of Medicine | Konya | 42080 | Turkey (Türkiye) |
| Royal Bournemouth General Hospital | Bournemouth | BH7 7DW | United Kingdom |
| Bristol Haematology & Oncology Centre | Bristol | BS2 8ED | United Kingdom |
| Royal Devon and Exeter Hospital (Wonford) | Exeter | EX2 5DW | United Kingdom |
| Beatson West of Scotland Cancer Centre | Glasgow | G12 OYN | United Kingdom |
| St James's University Hospital | Leeds | LS9 7TF | United Kingdom |
| University College London Hospital | London | NW1 2BU | United Kingdom |
| The Clatterbridge Cancer Centre | Metropolitan Borough of Wirral | CH63 4JY | United Kingdom |
| Derriford Hospital | Plymouth | PL6 8BQ | United Kingdom |
| Mount Vernon Hospital | Stevenage | SG1 4AB | United Kingdom |
| 33636453 | Derived | Park K, Ozguroglu M, Vansteenkiste J, Spigel D, Yang JC, Bajars M, Ruisi M, Manitz J, Barlesi F. Impact of subsequent immune checkpoint inhibitor treatment on overall survival with avelumab vs docetaxel in platinum-treated advanced NSCLC: Post hoc analyses from the phase 3 JAVELIN Lung 200 trial. Lung Cancer. 2021 Apr;154:92-98. doi: 10.1016/j.lungcan.2021.01.026. Epub 2021 Feb 6. |
| 30262187 | Derived | Barlesi F, Vansteenkiste J, Spigel D, Ishii H, Garassino M, de Marinis F, Ozguroglu M, Szczesna A, Polychronis A, Uslu R, Krzakowski M, Lee JS, Calabro L, Aren Frontera O, Ellers-Lenz B, Bajars M, Ruisi M, Park K. Avelumab versus docetaxel in patients with platinum-treated advanced non-small-cell lung cancer (JAVELIN Lung 200): an open-label, randomised, phase 3 study. Lancet Oncol. 2018 Nov;19(11):1468-1479. doi: 10.1016/S1470-2045(18)30673-9. Epub 2018 Sep 24. |
| US Medical Information website, Medical Resources | View source |
| Medical Information Location Map - Med Info Contacts | View source |
| FG001 |
| Docetaxel |
Participants received 75 mg per square meter (m^2) (per label) of docetaxel by intravenous infusion once every 3 weeks until confirmed disease progression, significant clinical deterioration, unacceptable toxicity, or any criterion for withdrawal from the study or Investigational Medicinal Product (IMP) as defined in the study protocol was fulfilled. |
| Treated |
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| COMPLETED |
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| NOT COMPLETED |
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Full analysis set (FAS) included all participants who were randomized to study.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Avelumab | Participants received 10 milligrams per kilogram (mg/kg) of avelumab as a 1-hour intravenous infusion once every 2 weeks until confirmed disease progression, significant clinical deterioration, unacceptable toxicity, or any criterion for withdrawal from the study or Investigational Medicinal Product (IMP) as defined in the study protocol was fulfilled. |
| BG001 | Docetaxel | Participants received 75 mg per square meter (m^2) (per label) of docetaxel by intravenous infusion once every 3 weeks until confirmed disease progression, significant clinical deterioration, unacceptable toxicity, or any criterion for withdrawal from the study or Investigational Medicinal Product (IMP) as defined in the study protocol was fulfilled. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| 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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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Overall Survival (OS) Time in Programmed Death Ligand 1 (PD-L1) + Full Analysis Set Population (FAS) | The OS time was defined as the time from randomization to the date of death. The participants who were still alive at the time of data analysis or who were lost to follow-up OS time was censored at the last recorded date that the participant was known to be alive before the data cutoff date. OS was measured using Kaplan-Meier (KM) estimates. | PD-L1+ FAS included all PD-L1+ tumor participants who were randomly assigned to trial treatment. The PD-L1+ participants were with greater than or equal to (>=) 1 percentage (%) of tumor cells with >=1+ positive membrane staining intensity for PD-L1 protein. | Posted | Median | 95% Confidence Interval | months | Time from date of randomization up to 1420 days |
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| Secondary | Overall Survival (OS) Time in Full Analysis Set Population | The OS time was defined as the time from randomization to the date of death. The participants who were still alive at the time of data analysis or who were lost to follow-up OS time was censored at the last recorded date that the participant was known to be alive before the data cutoff date. OS was measured using Kaplan-Meier (KM) estimates. | Full analysis set (FAS) included all participants who were randomized to study. | Posted | Median | 95% Confidence Interval | months | Time from date of randomization up to 1420 days |
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| Secondary | Progression-Free Survival (PFS) Time in PD-L1+ Full Analysis Set Population | PFS was defined as the time from date of randomization until date of the first documentation of progressive disease (PD) or death due to any cause in the absence of documented PD, whichever occurs first. PFS was assessed as per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) as adjudicated by independent endpoint review committee (IERC). PD was defined as at least a 20 percent (%) increase in the sum of longest diameter (SLD), taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions and unequivocal progression of non-target lesions. PFS was measured using Kaplan-Meier (KM) estimates. | PD-L1+ FAS included all PD-L1+ tumor participants who were randomly assigned to trial treatment. The PD-L1+ participants were with >= 1 percentage of tumor cells with >=1+ positive membrane staining intensity for PD-L1 protein. | Posted | Median | 95% Confidence Interval | months | Time from date of randomization up to 907 days |
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| Secondary | Progression-Free Survival (PFS) Time in Full Analysis Set Population | PFS was defined as the time from date of randomization until date of the first documentation of progressive disease (PD) or death due to any cause in the absence of documented PD, whichever occurs first. PFS was assessed as per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) as adjudicated by independent endpoint review committee (IERC). PD was defined as at least a 20 percent (%) increase in the sum of longest diameter (SLD), taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions and unequivocal progression of non-target lesions. PFS was measured using Kaplan-Meier (KM) estimates. | Full analysis set (FAS) included all participants who were randomized to study. | Posted | Median | 95% Confidence Interval | months | Time from date of randomization up to 907 days |
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| Secondary | Number of Participants With Confirmed Best Overall Response (BOR) as Assessed by an Independent Endpoint Review Committee (IERC) in Full Analysis Set Population | Confirmed BOR was determined according to RECIST v1.1 and as adjudicated by an IERC. Confirmed BOR was defined as the best response of any of the complete response (CR), partial response (PR), stable disease (SD) and progressive disease (PD) recorded from the date of randomization until disease progression or recurrence (taking the smallest measurement recorded since the start of treatment as reference). CR: Disappearance of all evidence of target and non-target lesions. PR: At least 30% reduction from baseline in the sum of the longest diameter (SLD) of all lesions. SD: Neither sufficient increase to qualify for PD nor sufficient shrinkage to qualify for PR. PD was defined as at least a 20% increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions and unequivocal progression of non-target lesions. Number of participants with best overall response in each category (CR, PR, SD, PD) was reported. | Full analysis set (FAS) included all participants who were randomized to study. | Posted | Count of Participants | Participants | Time from date of randomization up to 907 days |
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| Secondary | Number of Participants With Confirmed Best Overall Response (BOR) as Assessed by Independent Endpoint Review Committee (IERC) in PD-L1+ Full Analysis Set Population | Confirmed BOR was determined according to RECIST v1.1 and as adjudicated by an IERC. Confirmed BOR was defined as the best response of any of the complete response (CR), partial response (PR), stable disease (SD) and progressive disease (PD) recorded from the date of randomization until disease progression or recurrence (taking the smallest measurement recorded since the start of treatment as reference). CR: Disappearance of all evidence of target and non-target lesions. PR: At least 30% reduction from baseline in the sum of the longest diameter (SLD) of all lesions. SD: Neither sufficient increase to qualify for PD nor sufficient shrinkage to qualify for PR. PD was defined as at least a 20% increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions and unequivocal progression of non-target lesions. Number of participants with best overall response in each category (CR, PR, SD, PD) was reported. | PD-L1+ FAS included all PD-L1+ tumor participants who were randomly assigned to trial treatment. The PD-L1+ participants were with >= 1 percentage of tumor cells with >=1+ positive membrane staining intensity for PD-L1 protein. | Posted | Count of Participants | Participants | Time from date of randomization up to 907 days |
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| Secondary | Percentage of Participants With Objective Response as Assessed by Independent Endpoint Review Committee (IERC) in Full Analysis Set Population | Percentage of participants with objective response (CR plus PR) according to RECIST v1.1 was reported. CR: Disappearance of all evidence of target and non-target lesions. PR: At least 30% reduction from baseline in the sum of the longest diameter (SLD) of all lesions. | Full analysis set (FAS) included all participants who were randomized to study. | Posted | Number | 95% Confidence Interval | percentage of participants | Time from date of randomization up to 907 days |
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| Secondary | Percentage of Participants With Objective Response as Assessed by Independent Endpoint Review Committee (IERC) in PD-L1+ Full Analysis Set Population | Percentage of participants with objective response (CR plus PR) according to RECIST v1.1 was reported. CR: Disappearance of all evidence of target and non-target lesions. PR: At least 30% reduction from baseline in the sum of the longest diameter (SLD) of all lesions. | PD-L1+ FAS included all PD-L1+ tumor participants who were randomly assigned to trial treatment. The PD-L1+ participants were with >= 1 percentage of tumor cells with >=1+ positive membrane staining intensity for PD-L1 protein. | Posted | Number | 95% Confidence Interval | percentage of participants | Time from date of randomization up to 907 days |
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| Secondary | Change From Baseline in European Quality of Life 5-dimensions (EQ-5D-5L) Health Outcome Questionnaire Through Composite Index Score at End of Treatment (EOT) | The EQ-5D-5L health outcome questionnaire was a measure of health status that provides a simple descriptive profile and a single index value. The EQ-5D-5L defined health in terms of mobility, self-care, usual activities, pain/discomfort and anxiety/depression. The 5 items were combined to generate health profiles. These profiles were converted to a continuous single index score. The lowest possible score was -0.59 (unable to walk, unable to self-care, unable to do usual activities, extreme pain or discomfort, extreme anxiety or depression) and the highest was 1.00 (no problems in all 5 dimensions). | Health-related quality of life (HRQoL) analysis set was a subset of the FAS and includes all FAS participants who had 1 baseline HRQoL assessment and at least 1 post-baseline HRQoL questionnaire completed. Here, "Overall Number of Participants Analyzed" signified the participants analyzed in this outcome. | Posted | Mean | Standard Deviation | units on a scale | Baseline, End of treatment visit (up to Week 124) |
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| Secondary | Change From Baseline in European Quality of Life 5-dimensions (EQ-5D-5L) Health Outcome Questionnaire Through Visual Analogue Scale (VAS) at End of Treatment (EOT) | EQ-5D-5L was comprised of the following 5 participant-reported dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension had 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. The responses were used to derive overall score using a visual analog scale (VAS) that ranged from 0 to 100 millimeter (mm), where 0 was the worst health you can imagine and 100 was the best health you can imagine. | Health-related quality of life (HRQoL) analysis set was a subset of the FAS and includes all FAS participants who had 1 baseline HRQoL assessment and at least 1 post-baseline HRQoL questionnaire completed. Here, "Overall Number of Participants Analyzed" signified the participants analyzed in this outcome. | Posted | Mean | Standard Deviation | millimeter | Baseline, End of treatment visit (up to Week 124) |
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| Secondary | Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life (EORTC QLQ-C30) Global Health Status at End of Treatment (EOT) | EORTC QLQ-C30 was a 30-question tool used to assess the overall quality of life (QoL) in cancer participants. It consisted of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, role, cognitive, emotional, social), and 9 symptom scales/items (Fatigue, nausea and vomiting, pain, dyspnea, sleep disturbance, appetite loss, constipation, diarrhea, financial impact). The EORTC QLQ-C30 GHS/QoL score ranged from 0 to 100; High score indicated better GHS/QoL. Score 0 represents: very poor physical condition and QoL. Score 100 represents: excellent overall physical condition and QoL. | Health-related quality of life (HRQoL) analysis set was a subset of the FAS and includes all FAS participants who had 1 baseline HRQoL assessment and at least 1 post-baseline HRQoL questionnaire completed. Here, "Overall Number of Participants Analyzed" signified the participants analyzed in this outcome. | Posted | Mean | Standard Deviation | units on a scale | Baseline, End of treatment visit (up to Week 124) |
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| Secondary | Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13) at End of Treatment (EOT) | EORTC QLQ-LC13 consisted of 13 questions relating to disease symptoms specific to lung cancer and treatment side effects typical of treatment with chemotherapy and radiotherapy. The EORTC QLQ-LC13 module generated one multiple-item score assessing dyspnea and a series of single item scores assessing coughing, hemoptysis, sore mouth, dysphagia, neuropathy, alopecia, pain in chest, pain in arms or shoulder and pain in other parts. Score range: 0 (no burden of symptom domain or single symptom item) to 100 (highest burden of symptoms for symptom domains and single items). | Health-related quality of life (HRQoL) analysis set was a subset of the FAS and includes all FAS participants who had 1 baseline HRQoL assessment and at least 1 post-baseline HRQoL questionnaire completed. Here, "Number Analyzed" signified those participants who were evaluable for the specified category. | Posted | Mean | Standard Deviation | units on a scale | Baseline, End of treatment visit (up to Week 124) |
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| Secondary | Number of Participants With Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), Drug Related Treatment Emergent Adverse Events and Treatment Emergent Adverse Events Leading to Death | An Adverse event (AE) was defined as any unfavorable and unintended sign (including clinically significant abnormal laboratory, vital signs and 12-lead Electrocardiogram findings), symptom, or disease temporally associated with the use of study drug or worsening of pre-existing medical condition, whether or not related to study drug. A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect or was otherwise considered medically important. Treatment-emergent events were the events between first dose of study drug that were absent before treatment or that worsened relative to pre-treatment state up to 30 days after last administration. TEAEs included both Serious TEAEs and non-serious TEAEs. | Safety analysis set included all participants who were administered at least 1 dose of the Investigational Medicinal Product. | Posted | Count of Participants | Participants | Time from date of randomization up to 1420 days |
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| Secondary | Number of Participants With Treatment Emergent Adverse Events (TEAEs) by Severity | Treatment Emergent Adverse Events were graded as per National Cancer Institute Common Terminology Criteria for Adverse Experience version 4.03 (NCI-CTCAE v 4.03). Grade 3 refers to severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care and Activity of daily living (ADL), Grade 4 refers to Life-threatening consequences; where urgent intervention indicated, Grade 5 refers to the death related to adverse event. | Safety analysis set included all participants who were administered at least 1 dose of the Investigational Medicinal Product. | Posted | Count of Participants | Participants | Time from date of randomization up to 1420 days |
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| Secondary | Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance: Baseline Score vs. Worst Post-baseline Score | ECOG performance status measured to assess participant's performance status on a scale of 0 to 5, where 0 = Fully active, able to carry on all pre-disease activities without restriction; 1 = Restricted in physically strenuous activity, ambulatory and able to carry out light or sedentary work; 2 = Ambulatory and capable of all selfcare but unable to carry out any work activities; 3 = Capable of only limited self-care, confined to bed/chair for more than 50 percent of waking hours; 4 = Completely disabled, cannot carry on any self-care, totally confined to bed/chair; 5 = dead. The participants with missing worst post baseline score were also reported. ECOG performance status was reported in terms of number of participants with Baseline value vs. worst post-baseline value (i.e. highest score) combination. | Safety analysis set included all participants who were administered at least 1 dose of the Investigational Medicinal Product. | Posted | Count of Participants | Participants | Time from date of randomization up to 1420 days |
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| Secondary | Number of Participants With Positive Anti-Drug Antibodies (ADAs) and Neutralizing Antibodies (NAbs) for Avelumab | Serum samples were analyzed by a validated electrochemiluminesce immunoassay to detect the presence of antidrug antibodies (ADA). Samples that screened positive were subsequently tested in a confirmatory assay were tested for neutralizing antibodies (nAb). Number of participants with ADA or nAb positive results for Avelumab were reported. | Full analysis set (FAS) included all participants who were randomized to study. Here, "Overall Number of Participants Analyzed" signified participants with at least on valid ADA result at any time point. | Posted | Count of Participants | Participants | Time from date of randomization up to 1420 days |
|
|
Time from date of randomization up to 1420 days.
Safety analysis set included all participants who were administered at least 1 dose of the Investigational Medicinal Product.
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 | Avelumab | Participants received 10 milligrams per kilogram (mg/kg) of avelumab as a 1-hour intravenous infusion once every 2 weeks until confirmed disease progression, significant clinical deterioration, unacceptable toxicity, or any criterion for withdrawal from the study or Investigational Medicinal Product (IMP) as defined in the study protocol was fulfilled. | 316 | 393 | 167 | 393 | 320 | 393 |
| EG001 | Docetaxel | Participants received 75 mg per square meter (m^2) (per label) of docetaxel by intravenous infusion once every 3 weeks until confirmed disease progression, significant clinical deterioration, unacceptable toxicity, or any criterion for withdrawal from the study or Investigational Medicinal Product (IMP) as defined in the study protocol was fulfilled. | 297 | 365 | 145 | 365 | 307 | 365 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Disease progression | General disorders | MedDRA version 21.1 | Non-systematic Assessment |
| |
| Asthenia | General disorders | MedDRA version 21.1 | Non-systematic Assessment |
| |
| Death | General disorders | MedDRA version 21.1 | Non-systematic Assessment |
| |
| Pain | General disorders | MedDRA version 21.1 | Non-systematic Assessment |
| |
| Chest pain | General disorders | MedDRA version 21.1 | Non-systematic Assessment |
| |
| Chills | General disorders | MedDRA version 21.1 | Non-systematic Assessment |
| |
| General physical health deterioration | General disorders | MedDRA version 21.1 | Non-systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA version 21.1 | Non-systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA version 21.1 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA version 21.1 | Non-systematic Assessment |
| |
| Malaise | General disorders | MedDRA version 21.1 | Non-systematic Assessment |
| |
| Mucosal inflammation | General disorders | MedDRA version 21.1 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA version 21.1 | Non-systematic Assessment |
| |
| Sudden cardiac death | General disorders | MedDRA version 21.1 | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA version 21.1 | Non-systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA version 21.1 | Non-systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA version 21.1 | Non-systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA version 21.1 | Non-systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA version 21.1 | Non-systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA version 21.1 | Non-systematic Assessment |
| |
| Interstitial lung disease | Respiratory, thoracic and mediastinal disorders | MedDRA version 21.1 | Non-systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA version 21.1 | Non-systematic Assessment |
| |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA version 21.1 | Non-systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA version 21.1 | Non-systematic Assessment |
| |
| Acute respiratory distress syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA version 21.1 | Non-systematic Assessment |
| |
| Asphyxia | Respiratory, thoracic and mediastinal disorders | MedDRA version 21.1 | Non-systematic Assessment |
| |
| Atelectasis | Respiratory, thoracic and mediastinal disorders | MedDRA version 21.1 | Non-systematic Assessment |
| |
| Hydrothorax | Respiratory, thoracic and mediastinal disorders | MedDRA version 21.1 | Non-systematic Assessment |
| |
| Oesophagobronchial fistula | Respiratory, thoracic and mediastinal disorders | MedDRA version 21.1 | Non-systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA version 21.1 | Non-systematic Assessment |
| |
| Pulmonary haemorrhage | Respiratory, thoracic and mediastinal disorders | MedDRA version 21.1 | Non-systematic Assessment |
| |
| Bronchial obstruction | Respiratory, thoracic and mediastinal disorders | MedDRA version 21.1 | Non-systematic Assessment |
| |
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA version 21.1 | Non-systematic Assessment |
| |
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | MedDRA version 21.1 | Non-systematic Assessment |
| |
| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA version 21.1 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA version 21.1 | Non-systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA version 21.1 | Non-systematic Assessment |
| |
| Lung infection | Infections and infestations | MedDRA version 21.1 | Non-systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA version 21.1 | Non-systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA version 21.1 | Non-systematic Assessment |
| |
| Encephalitis | Infections and infestations | MedDRA version 21.1 | Non-systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA version 21.1 | Non-systematic Assessment |
| |
| Infective exacerbation of chronic obstructive airways disease | Infections and infestations | MedDRA version 21.1 | Non-systematic Assessment |
| |
| Pleural infection | Infections and infestations | MedDRA version 21.1 | Non-systematic Assessment |
| |
| Pneumonia streptococcal | Infections and infestations | MedDRA version 21.1 | Non-systematic Assessment |
| |
| Postoperative wound infection | Infections and infestations | MedDRA version 21.1 | Non-systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA version 21.1 | Non-systematic Assessment |
| |
| Diabetic gangrene | Infections and infestations | MedDRA version 21.1 | Non-systematic Assessment |
| |
| Infection | Infections and infestations | MedDRA version 21.1 | Non-systematic Assessment |
| |
| Klebsiella infection | Infections and infestations | MedDRA version 21.1 | Non-systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | MedDRA version 21.1 | Non-systematic Assessment |
| |
| Meningitis | Infections and infestations | MedDRA version 21.1 | Non-systematic Assessment |
| |
| Neutropenic infection | Infections and infestations | MedDRA version 21.1 | Non-systematic Assessment |
| |
| Neutropenic sepsis | Infections and infestations | MedDRA version 21.1 | Non-systematic Assessment |
| |
| Peritonitis | Infections and infestations | MedDRA version 21.1 | Non-systematic Assessment |
| |
| Pneumocystis jirovecii pneumonia | Infections and infestations | MedDRA version 21.1 | Non-systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA version 21.1 | Non-systematic Assessment |
| |
| Serratia infection | Infections and infestations | MedDRA version 21.1 | Non-systematic Assessment |
| |
| Soft tissue infection | Infections and infestations | MedDRA version 21.1 | Non-systematic Assessment |
| |
| Streptococcal infection | Infections and infestations | MedDRA version 21.1 | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA version 21.1 | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA version 21.1 | Non-systematic Assessment |
| |
| Urosepsis | Infections and infestations | MedDRA version 21.1 | Non-systematic Assessment |
| |
| Infusion related reaction | Injury, poisoning and procedural complications | MedDRA version 21.1 | Non-systematic Assessment |
| |
| Femoral neck fracture | Injury, poisoning and procedural complications | MedDRA version 21.1 | Non-systematic Assessment |
| |
| Brain contusion | Injury, poisoning and procedural complications | MedDRA version 21.1 | Non-systematic Assessment |
| |
| Femur fracture | Injury, poisoning and procedural complications | MedDRA version 21.1 | Non-systematic Assessment |
| |
| Post procedural haemorrhage | Injury, poisoning and procedural complications | MedDRA version 21.1 | Non-systematic Assessment |
| |
| Lumbar vertebral fracture | Injury, poisoning and procedural complications | MedDRA version 21.1 | Non-systematic Assessment |
| |
| Spinal compression fracture | Injury, poisoning and procedural complications | MedDRA version 21.1 | Non-systematic Assessment |
| |
| Metastases to central nervous system | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 21.1 | Non-systematic Assessment |
| |
| Malignant pleural effusion | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 21.1 | Non-systematic Assessment |
| |
| Metastases to bone | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 21.1 | Non-systematic Assessment |
| |
| Colorectal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 21.1 | Non-systematic Assessment |
| |
| Malignant neoplasm progression | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 21.1 | Non-systematic Assessment |
| |
| Metastases to liver | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 21.1 | Non-systematic Assessment |
| |
| Metastases to meninges | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 21.1 | Non-systematic Assessment |
| |
| Metastatic neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 21.1 | Non-systematic Assessment |
| |
| Tumour pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 21.1 | Non-systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA version 21.1 | Non-systematic Assessment |
| |
| Pericardial effusion | Cardiac disorders | MedDRA version 21.1 | Non-systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | MedDRA version 21.1 | Non-systematic Assessment |
| |
| Acute coronary syndrome | Cardiac disorders | MedDRA version 21.1 | Non-systematic Assessment |
| |
| Angina unstable | Cardiac disorders | MedDRA version 21.1 | Non-systematic Assessment |
| |
| Autoimmune myocarditis | Cardiac disorders | MedDRA version 21.1 | Non-systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA version 21.1 | Non-systematic Assessment |
| |
| Cardiac failure acute | Cardiac disorders | MedDRA version 21.1 | Non-systematic Assessment |
| |
| Cardiac tamponade | Cardiac disorders | MedDRA version 21.1 | Non-systematic Assessment |
| |
| Cardiomyopathy | Cardiac disorders | MedDRA version 21.1 | Non-systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA version 21.1 | Non-systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA version 21.1 | Non-systematic Assessment |
| |
| Arrhythmia supraventricular | Cardiac disorders | MedDRA version 21.1 | Non-systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA version 21.1 | Non-systematic Assessment |
| |
| Cardiovascular insufficiency | Cardiac disorders | MedDRA version 21.1 | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA version 21.1 | Non-systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | MedDRA version 21.1 | Non-systematic Assessment |
| |
| Ascites | Gastrointestinal disorders | MedDRA version 21.1 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA version 21.1 | Non-systematic Assessment |
| |
| Gastric haemorrhage | Gastrointestinal disorders | MedDRA version 21.1 | Non-systematic Assessment |
| |
| Gastritis erosive | Gastrointestinal disorders | MedDRA version 21.1 | Non-systematic Assessment |
| |
| Gastrointestinal pain | Gastrointestinal disorders | MedDRA version 21.1 | Non-systematic Assessment |
| |
| Ileus | Gastrointestinal disorders | MedDRA version 21.1 | Non-systematic Assessment |
| |
| Melaena | Gastrointestinal disorders | MedDRA version 21.1 | Non-systematic Assessment |
| |
| Subileus | Gastrointestinal disorders | MedDRA version 21.1 | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA version 21.1 | Non-systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA version 21.1 | Non-systematic Assessment |
| |
| Ileus paralytic | Gastrointestinal disorders | MedDRA version 21.1 | Non-systematic Assessment |
| |
| Intestinal perforation | Gastrointestinal disorders | MedDRA version 21.1 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA version 21.1 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA version 21.1 | Non-systematic Assessment |
| |
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA version 21.1 | Non-systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA version 21.1 | Non-systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA version 21.1 | Non-systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA version 21.1 | Non-systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA version 21.1 | Non-systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA version 21.1 | Non-systematic Assessment |
| |
| Electrolyte imbalance | Metabolism and nutrition disorders | MedDRA version 21.1 | Non-systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA version 21.1 | Non-systematic Assessment |
| |
| Hypophagia | Metabolism and nutrition disorders | MedDRA version 21.1 | Non-systematic Assessment |
| |
| Depressed level of consciousness | Nervous system disorders | MedDRA version 21.1 | Non-systematic Assessment |
| |
| Balance disorder | Nervous system disorders | MedDRA version 21.1 | Non-systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA version 21.1 | Non-systematic Assessment |
| |
| Hemiparesis | Nervous system disorders | MedDRA version 21.1 | Non-systematic Assessment |
| |
| Hemiplegia | Nervous system disorders | MedDRA version 21.1 | Non-systematic Assessment |
| |
| Neurotoxicity | Nervous system disorders | MedDRA version 21.1 | Non-systematic Assessment |
| |
| Post herpetic neuralgia | Nervous system disorders | MedDRA version 21.1 | Non-systematic Assessment |
| |
| Seizure | Nervous system disorders | MedDRA version 21.1 | Non-systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA version 21.1 | Non-systematic Assessment |
| |
| Cerebral infarction | Nervous system disorders | MedDRA version 21.1 | Non-systematic Assessment |
| |
| Haemorrhage intracranial | Nervous system disorders | MedDRA version 21.1 | Non-systematic Assessment |
| |
| Loss of consciousness | Nervous system disorders | MedDRA version 21.1 | Non-systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA version 21.1 | Non-systematic Assessment |
| |
| Spinal cord compression | Nervous system disorders | MedDRA version 21.1 | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA version 21.1 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA version 21.1 | Non-systematic Assessment |
| |
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA version 21.1 | Non-systematic Assessment |
| |
| Osteoporotic fracture | Musculoskeletal and connective tissue disorders | MedDRA version 21.1 | Non-systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA version 21.1 | Non-systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA version 21.1 | Non-systematic Assessment |
| |
| Pathological fracture | Musculoskeletal and connective tissue disorders | MedDRA version 21.1 | Non-systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA version 21.1 | Non-systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | MedDRA version 21.1 | Non-systematic Assessment |
| |
| Renal impairment | Renal and urinary disorders | MedDRA version 21.1 | Non-systematic Assessment |
| |
| Superior vena cava syndrome | Vascular disorders | MedDRA version 21.1 | Non-systematic Assessment |
| |
| Aortic aneurysm | Vascular disorders | MedDRA version 21.1 | Non-systematic Assessment |
| |
| Intermittent claudication | Vascular disorders | MedDRA version 21.1 | Non-systematic Assessment |
| |
| Peripheral arterial occlusive disease | Vascular disorders | MedDRA version 21.1 | Non-systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA version 21.1 | Non-systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA version 21.1 | Non-systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA version 21.1 | Non-systematic Assessment |
| |
| Febrile bone marrow aplasia | Blood and lymphatic system disorders | MedDRA version 21.1 | Non-systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA version 21.1 | Non-systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA version 21.1 | Non-systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA version 21.1 | Non-systematic Assessment |
| |
| Adrenal insufficiency | Endocrine disorders | MedDRA version 21.1 | Non-systematic Assessment |
| |
| Autoimmune thyroiditis | Endocrine disorders | MedDRA version 21.1 | Non-systematic Assessment |
| |
| Cholangitis | Hepatobiliary disorders | MedDRA version 21.1 | Non-systematic Assessment |
| |
| Hepatic function abnormal | Hepatobiliary disorders | MedDRA version 21.1 | Non-systematic Assessment |
| |
| Hypersensitivity | Immune system disorders | MedDRA version 21.1 | Non-systematic Assessment |
| |
| Angioedema | Skin and subcutaneous tissue disorders | MedDRA version 21.1 | Non-systematic Assessment |
| |
| Henoch-Schonlein purpura | Skin and subcutaneous tissue disorders | MedDRA version 21.1 | Non-systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA version 21.1 | Non-systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA version 21.1 | Non-systematic Assessment |
| |
| Vision blurred | Eye disorders | MedDRA version 21.1 | Non-systematic Assessment |
| |
| Gamma-glutamyltransferase increased | Investigations | MedDRA version 21.1 | Non-systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA version 21.1 | Non-systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA version 21.1 | Non-systematic Assessment |
| |
| Cystic lung disease | Respiratory, thoracic and mediastinal disorders | MedDRA version 21.1 | Non-systematic Assessment |
| |
| Left ventricular dysfunction | Cardiac disorders | MedDRA version 21.1 | Non-systematic Assessment |
| |
| Colitis ulcerative | Gastrointestinal disorders | MedDRA version 21.1 | Non-systematic Assessment |
| |
| Thrombotic cerebral infarction | Nervous system disorders | MedDRA version 21.1 | Non-systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA version 21.1 | Non-systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA version 21.1 | Non-systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA version 21.1 | Non-systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA version 21.1 | Non-systematic Assessment |
| |
| Blood creatine phosphokinase increased | Investigations | MedDRA version 21.1 | Non-systematic Assessment |
| |
| Agitation | Psychiatric disorders | MedDRA version 21.1 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fatigue | General disorders | MedDRA version 21.1 | Non-systematic Assessment |
| |
| Asthenia | General disorders | MedDRA version 21.1 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA version 21.1 | Non-systematic Assessment |
| |
| Chills | General disorders | MedDRA version 21.1 | Non-systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA version 21.1 | Non-systematic Assessment |
| |
| Malaise | General disorders | MedDRA version 21.1 | Non-systematic Assessment |
| |
| Mucosal inflammation | General disorders | MedDRA version 21.1 | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA version 21.1 | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA version 21.1 | Non-systematic Assessment |
| |
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA version 21.1 | Non-systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA version 21.1 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA version 21.1 | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA version 21.1 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA version 21.1 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA version 21.1 | Non-systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA version 21.1 | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA version 21.1 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA version 21.1 | Non-systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA version 21.1 | Non-systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA version 21.1 | Non-systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA version 21.1 | Non-systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA version 21.1 | Non-systematic Assessment |
| |
| Infusion related reaction | Injury, poisoning and procedural complications | MedDRA version 21.1 | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA version 21.1 | Non-systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA version 21.1 | Non-systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA version 21.1 | Non-systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA version 21.1 | Non-systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA version 21.1 | Non-systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA version 21.1 | Non-systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA version 21.1 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA version 21.1 | Non-systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | MedDRA version 21.1 | Non-systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA version 21.1 | Non-systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA version 21.1 | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA version 21.1 | Non-systematic Assessment |
| |
| Hypothyroidism | Endocrine disorders | MedDRA version 21.1 | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA version 21.1 | Non-systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA version 21.1 | Non-systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Communication Center | Merck KGaA, Darmstadt, Germany | +49-6151-72-5200 | service@emdgroup.com |
| SAP_000.pdf |
| Prot | Yes | No | No | Study Protocol | Jan 10, 2017 | Nov 20, 2018 | Prot_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 |
|---|---|
| C000609138 | avelumab |
| 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 |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| Not collected at the site |
|
| Other |
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
Participants received 75 mg per square meter (m^2) (per label) of docetaxel by intravenous infusion once every 3 weeks until confirmed disease progression, significant clinical deterioration, unacceptable toxicity, or any criterion for withdrawal from the study or Investigational Medicinal Product (IMP) as defined in the study protocol was fulfilled.
|
|
|
|
|
|
| OG001 | Docetaxel | Participants received 75 mg per square meter (m^2) (per label) of docetaxel by intravenous infusion once every 3 weeks until confirmed disease progression, significant clinical deterioration, unacceptable toxicity, or any criterion for withdrawal from the study or Investigational Medicinal Product (IMP) as defined in the study protocol was fulfilled. |
|
|
| OG001 | Docetaxel | Participants received 75 mg per square meter (m^2) (per label) of docetaxel by intravenous infusion once every 3 weeks until confirmed disease progression, significant clinical deterioration, unacceptable toxicity, or any criterion for withdrawal from the study or Investigational Medicinal Product (IMP) as defined in the study protocol was fulfilled. |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
|
|
|
| Docetaxel |
Participants received 75 mg per square meter (m^2) (per label) of docetaxel by intravenous infusion once every 3 weeks until confirmed disease progression, significant clinical deterioration, unacceptable toxicity, or any criterion for withdrawal from the study or Investigational Medicinal Product (IMP) as defined in the study protocol was fulfilled. |
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Participants received 75 mg per square meter (m^2) (per label) of docetaxel by intravenous infusion once every 3 weeks until confirmed disease progression, significant clinical deterioration, unacceptable toxicity, or any criterion for withdrawal from the study or Investigational Medicinal Product (IMP) as defined in the study protocol was fulfilled.
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| Docetaxel |
Participants received 75 mg per square meter (m^2) (per label) of docetaxel by intravenous infusion once every 3 weeks until confirmed disease progression, significant clinical deterioration, unacceptable toxicity, or any criterion for withdrawal from the study or Investigational Medicinal Product (IMP) as defined in the study protocol was fulfilled. |
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Participants received 75 mg per square meter (m^2) (per label) of docetaxel by intravenous infusion once every 3 weeks until confirmed disease progression, significant clinical deterioration, unacceptable toxicity, or any criterion for withdrawal from the study or Investigational Medicinal Product (IMP) as defined in the study protocol was fulfilled. |
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| OG001 | Docetaxel | Participants received 75 mg per square meter (m^2) (per label) of docetaxel by intravenous infusion once every 3 weeks until confirmed disease progression, significant clinical deterioration, unacceptable toxicity, or any criterion for withdrawal from the study or Investigational Medicinal Product (IMP) as defined in the study protocol was fulfilled. |
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| Docetaxel |
Participants received 75 mg per square meter (m^2) (per label) of docetaxel by intravenous infusion once every 3 weeks until confirmed disease progression, significant clinical deterioration, unacceptable toxicity, or any criterion for withdrawal from the study or Investigational Medicinal Product (IMP) as defined in the study protocol was fulfilled. |
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