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At present there are no approved predictive tumour- or serum-derived biomarkers guiding usage of anti-angiogenic therapies in patients with adenocarcinoma of NSCLC.The objective of this NIS is to examine whether genetic/genomic markers (alone or combined with clinical covariates) could be used to predict OS in NSCLC patients eligible for treatment with Vargatef®. The investigations in this study are exploratory in nature and considered to be hypothesis generating. The results from these investigations may help to expand our understanding of the disease and the response to Vargatef®.
Purpose:
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Overall Survival (OS) Event | Overall survival (OS) was defined as the time from start of entering the study to time of death. For the analysis of overall survival, participants were censored at the date of the last contact if the physician was no longer able to contact a participants or caregiver, and the vital status could not otherwise be determined. Enrolled participants who never received the combination therapy of docetaxel and Vargatef® were censored on the day of enrolment. Calculation of OS: For participants with known date of death: OS [days] = date of death - date of treatment start + 1 For participants known to be alive by the end of the study or at follow-up visit: OS (censored) [days] = date of last contact when the Patient was known to be alive - date of treatment start + 1. | From start of entering the study until death or last contact date, up to 42 months. |
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Inclusion criteria:
Exclusion criteria:
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NSCLC patients under Vargatef® treatment according to label
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| Name | Affiliation | Role |
|---|---|---|
| Boehringer Ingelheim | Boehringer Ingelheim | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| LK Krems | Krems | 3500 | Austria | |||
| AKH - Medical University of Vienna |
Only subjects that met all the study inclusion criteria were to be entered in the study. All subjects were free to withdraw from the non-interventional study at any time for any reason given.
Non-interventional study based on newly collected data in patients with Non-Small Cell Lung Cancer of adenocarcinoma tumour, who, for the first time, received Vargatef® as part of the routine treatment according to the approved label (new users design), to explore whether genetic or genomic markers could be used to predict Overall Survival.
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| ID | Title | Description |
|---|---|---|
| FG000 | 200mg Vargatef® | Participants with Non-Small Cell Lung Cancer (NSCLC) were administered soft capsules of 200 milligram (mg) Vargatef® twice daily (except the day of docetaxel Infusion) in combination with 75mg/m² docetaxel every 21 days as indicated in the approved Labels of Vargatef® and docetaxel. Participants were followed-up every 6 months until they died, were lost to follow-up, withdrew consent, or until the required number of Overall Survival Events had occurred, whichever occurred first. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 9, 2019 | Aug 21, 2020 |
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FPE tumour tissue and one blood sample. A buccal swab may replace the blood sample if not available.
| Vienna |
| 1090 |
| Austria |
| Brussels - UNIV Saint-Luc | Brussels | 1200 | Belgium |
| AZ Maria Middelares | Ghent | 9000 | Belgium |
| AZ Sint-Lucas - Campus Sint Lucas | Ghent | 9000 | Belgium |
| Ieper - HOSP Jan Yperman | Ieper | 8900 | Belgium |
| Liège - HOSP CHR de la Citadelle | Liège | 4000 | Belgium |
| Charleroi - UNIV CHU de Charleroi | Lodelinsart | 6042 | Belgium |
| Roeselare - HOSP AZ Delta | Roeselare | 8800 | Belgium |
| Herlev and Gentofte Hospital | Herlev | 2730 | Denmark |
| Gesundheit Nord gGmbH | Klinikverbund Bremen | Bremen | 28325 | Germany |
| Florence-Nightingale-Krankenhaus der Kaiserswerther Diakonie | Düsseldorf | 40489 | Germany |
| Pneumologisches Forschungsinstitut an der LungenClinic Grosshansdorf GmbH | Großhansdorf | 22927 | Germany |
| Onkologische Schwerpunktpraxis | Kaiserslautern | 67655 | Germany |
| Klinik, Löwenstein | Löwenstein | 74245 | Germany |
| Thoraxzentrum Bezirk Unterfranken | Münnerstadt | 97702 | Germany |
| Klinikum Nürnberg | Nuremberg | 90419 | Germany |
| Pius-Hospital, Oldenburg | Oldenburg | 26121 | Germany |
| Caritas Klinik St. Theresia; Saarbrücken | Saarbrücken | 66113 | Germany |
| SHG-Kliniken Völklingen | Völklingen | 66333 | Germany |
| Athens Hospital of Chest Dis. | Athens | 11527 | Greece |
| University General Hospital of Heraklion | Heraklion | 71110 | Greece |
| European Interbalkan Medical Centre | Thessaloniki | 555 35 | Greece |
| National Koranyi TBC and Pulm. Internal Med. Clinic | Budapest | 1121 | Hungary |
| Lung Hospital of Matra, Dept. Pulmonology | Mátraháza | 3233 | Hungary |
| BAZ County Central Hospital and University Teaching Hospital | Miskolc | 3526 | Hungary |
| Azienda Ospedaliera Santi Antonio e Biagio e Cesare Arrigo | Alessandria | 15100 | Italy |
| Azienda Ospedaliera Ospedali Riuniti Villa Sofia - Cervello | Palermo | 90146 | Italy |
| Hospital of Lithuanian Univ.of HealthSciences Kauno Klinikos | Kaunas | LT-50009 | Lithuania |
| National Cancer Institute, Vilnius | Vilnius | 08660 | Lithuania |
| Luxembourg - HOSP CH de Luxembourg | Luxembourg | 1210 | Luxembourg |
| OLVG, locatie Oosterpark | Amsterdam | 1091 AC | Netherlands |
| Ziekenhuis Gelderse Vallei | Ede | 6716 RP | Netherlands |
| Martini Ziekenhuis | Groningen | 9728 NT | Netherlands |
| Sint Jansdal Ziekenhuis | Harderwijk | 3844 DG | Netherlands |
| Ziekenhuisgroep Twente locatie Hengelo | Hengelo | 7555DL | Netherlands |
| Tergooi Ziekenhuis | Hilversum | 1213 XZ | Netherlands |
| Maasstad Ziekenhuis | Rotterdam | 3079 DZ | Netherlands |
| Hospital General Universitario de Alicante | Alicante | 03010 | Spain |
| Hospital Universitario de Burgos | Buegos | 09006 | Spain |
| Hospital Universitari de Girona Doctor Josep Trueta | Girona | 17007 | Spain |
| Complejo Hospitalario de Jaén | Jaén | 23007 | Spain |
| Complejo Hospitalario Universitario Insular - Materno Infantil | Las Palmas de Gran Canaria | 35016 | Spain |
| Hospital Severo Ochoa | Leganes - Madrid | 28911 | Spain |
| Hospital de León | León | 24008 | Spain |
| Hospital Universitario Lucus Augusti | Lugo | 27003 | Spain |
| Hospital ClÃnico San Carlos | Madrid | 28040 | Spain |
| Hospital La Paz | Madrid | 28046 | Spain |
| Hospital de Mataró | Mataró | 08304 | Spain |
| Hospital Son Espases | Palma de Mallorca | 07010 | Spain |
| Complejo Hospitalario de Navarra | Pamplona | 31008 | Spain |
| CS Parc Taulà | Sabadell | 08208 | Spain |
| Hospital Universitario Marqués de Valdecilla | Santander | 39008 | Spain |
| Hospital Virgen del RocÃo | Seville | 41013 | Spain |
| Hospital Virgen Macarena | Seville | 41071 | Spain |
| Consorci Sanitari de Terrassa - Hospital de Terrassa | Terrassa | 08227 | Spain |
| Hospital Arnau de Vilanova | Valencia | 46015 | Spain |
| Hospital ClÃnico Universitario de Valladolid | Valladolid | 47005 | Spain |
| Gävle Sjukhus | Gävle | 801 87 | Sweden |
| Universitetssjukhuset, Linköping | Linköping | 581 85 | Sweden |
| Karolinska Univ. sjukhuset | Stockholm | 171 76 | Sweden |
| Akademiska sjukhuset | Uppsala | 751 85 | Sweden |
| Aberdeen Royal Infirmary | Aberdeen | AB25 2ZN | United Kingdom |
| Clatterbridge Cancer Centre | Bebington, Wirral | CH63 4JY | United Kingdom |
| West Suffolk Hospital | Bury St Edmunds | IP33 2QZ | United Kingdom |
| Royal Devon and Exeter Hospital | Exeter | EX2 5DW | United Kingdom |
| Ipswich Hospital | Ipswich | IP4 5PD | United Kingdom |
| Airedale General Hospital | Keighley | BD20 6TD | United Kingdom |
| James Cook University Hospital | Middlesbrough | TS4 3BW | United Kingdom |
| Freeman Hospital | Newcastle upon Tyne | NE7 7DN | United Kingdom |
| Derriford Hospital | Plymouth | PL6 8DH | United Kingdom |
| Not Treated With Vargatef® |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Entered Set: All patients who entered the study, no matter if they acutally had taken Vargatef®.
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| ID | Title | Description |
|---|---|---|
| BG000 | 200mg Vargatef® | Participants with Non-Small Cell Lung Cancer (NSCLC) were administered soft capsules of 200 milligram (mg) Vargatef® twice daily (except the day of docetaxel Infusion) in combination with 75mg/m² docetaxel every 21 days as indicated in the approved Labels of Vargatef® and docetaxel. Participants were followed-up every 6 months until they died, were lost to follow-up, withdrew consent, or until the required number of Overall Survival Events had occurred, whichever occurred first. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | 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 | Number of Participants With Overall Survival (OS) Event | Overall survival (OS) was defined as the time from start of entering the study to time of death. For the analysis of overall survival, participants were censored at the date of the last contact if the physician was no longer able to contact a participants or caregiver, and the vital status could not otherwise be determined. Enrolled participants who never received the combination therapy of docetaxel and Vargatef® were censored on the day of enrolment. Calculation of OS: For participants with known date of death: OS [days] = date of death - date of treatment start + 1 For participants known to be alive by the end of the study or at follow-up visit: OS (censored) [days] = date of last contact when the Patient was known to be alive - date of treatment start + 1. | Entered Set: All patients who entered the study, no matter if they actually had taken Vargatef®. | Posted | Count of Participants | Participants | From start of entering the study until death or last contact date, up to 42 months. |
|
|
|
|
From first administration of study medication (Vargatef®) until 30 days after the last administration of study medication (Vargatef®), up to 807 days.
For All-Cause Mortality the entered set (All patients who entered the study, no matter if they actually had taken Vargatef® ) was used.
For serious and other adverse events, the Treated Set (All patients who were documented to have taken at least 1 Vargatef® dose) was used.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 200mg Vargatef® | Participants with Non-Small Cell Lung Cancer (NSCLC) were administered soft capsules of 200 milligram (mg) Vargatef® twice daily (except the day of docetaxel Infusion) in combination with 75mg/m² docetaxel every 21 days as indicated in the approved Labels of Vargatef® and docetaxel. Participants were followed-up every 6 months until they died, were lost to follow-up, withdrew consent, or until the required number of Overall Survival Events had occurred, whichever occurred first. | 209 | 260 | 127 | 257 | 93 | 257 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Agranulocytosis | Blood and lymphatic system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Neutrophilia | Blood and lymphatic system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Atrioventricular block complete | Cardiac disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Cardio-respiratory arrest | Cardiac disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Vision blurred | Eye disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Enteritis | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Gastrointestinal perforation | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Haematemesis | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Haemorrhoids | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Ileus | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Intestinal perforation | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Large intestine perforation | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Rectal haemorrhage | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Death | General disorders | MedDRA 22.0 | Systematic Assessment |
| |
| General physical health deterioration | General disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Malaise | General disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Mucosal inflammation | General disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Multiple organ dysfunction syndrome | General disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Pain | General disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Performance status decreased | General disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Campylobacter gastroenteritis | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| Clostridial infection | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| Device related infection | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| Fournier's gangrene | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| Infection | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| Meningoencephalitis herpetic | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| Neutropenic sepsis | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| Perirectal abscess | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| Pulmonary sepsis | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| Post procedural haemorrhage | Injury, poisoning and procedural complications | MedDRA 22.0 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 22.0 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 22.0 | Systematic Assessment |
| |
| C-reactive protein increased | Investigations | MedDRA 22.0 | Systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA 22.0 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Malignant neoplasm progression | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 22.0 | Systematic Assessment |
| |
| Metastases to central nervous system | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 22.0 | Systematic Assessment |
| |
| Aphasia | Nervous system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Cerebral infarction | Nervous system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Coma | Nervous system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Ischaemic stroke | Nervous system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Peripheral motor neuropathy | Nervous system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Seizure | Nervous system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Device occlusion | Product Issues | MedDRA 22.0 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Acute respiratory distress syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Tachypnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Rash generalised | Skin and subcutaneous tissue disorders | MedDRA 22.0 | Systematic Assessment |
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| Embolism | Vascular disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Vena cava thrombosis | Vascular disorders | MedDRA 22.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 22.0 | Systematic Assessment |
|
The planned number of 250 overall survival events could not be reached. Therefore, in agreement with the European Medicines Agency (EMA), the study was analysed earlier.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Boehringer Ingelheim, Call Centre | Boehringer Ingelheim | 1-800-243-0127 | clintriage.rdg@boehringer-ingelheim.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 28, 2019 | Aug 21, 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 |
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| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|