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This is a study of brigatinib in adults with Non-Small Cell Lung Cancer (NSCLC). The main aim of this study is to learn about the time period in which the condition does not worsen after the participant has received brigatinib. Another aim is to learn about the overall rate of participants who respond to the treatment with brigatinib.
Participants will receive brigatinib as part of their normal clinical practice. Data will be collected during regular visits to the hospital (a total of up to 12 visits is planned throughout study duration).
This is a non-interventional, prospective study of Polish participants with ALK positive NSCLC receiving Brigatinib as their first line of treatment in the scope of routine clinical practice within the frames of National Drug Program (NDP). This study will evaluate progression-free survival (from the time of the first dose of brigatinib).
This study will enrol approximately 50 participants. Participants will be enrolled in the following cohort to be observed at baseline, and every 3 months up to 33 months:
• Brigatinib
This multi-center trial will be conducted in Poland. The overall duration of the study will include approximately 18 months of enrolment and approximately 33 months of data collection and follow-up.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Brigatinib | Participants receiving Brigatinib as part of their first-line treatment in scope of their routine clinical practice within the frames of National Drug Program (NDP) will be observed at baseline, and every 3 months (± 1 month) at routine follow-up for up to 33 months. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| No intervention | Drug | As this is an observational study, no intervention will be administered. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Real-World Progression Free Survival (rwPFS) | rwPFS is defined as the time from starting treatment to the time of radiographic progression according to Response evaluation criteria in solid tumors (RECIST) v1.1 criteria. | Up to 33 months |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS) | OS is defined as the time from starting treatment with brigatinib until death due to any cause or loss to follow-up. | Up to 33 months |
| Real-World Overall Response Rate (rwORR) |
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Inclusion Criteria
Exclusion Criteria
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Participants diagnosed with ALK positive NSCLC who received brigatinib in first-line treatment in Poland.
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| Name | Affiliation | Role |
|---|---|---|
| Study Director | Takeda | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dolnoslskie Centrum Onkologii, Pulmonologii i Hematologii | Wroclaw | Dolnoslskie | 53-413 | Poland | ||
| Szpital Kliniczny im. Heliodora Swiecickiego UM wPoznaniu. |
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| Label | URL |
|---|---|
| Click here for more information about this trial in easy-to-understand language. | View source |
| Click here to ask Takeda's chatbot for comprehensive and easy-to-understand information about clinical trials - even across products and indications - in your local language. | View source |
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Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
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IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
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Biospecimen collected would be blood samples.
rwORR (including intracranial response) is defined as the sum of the partial and complete response according to RECIST version 1.1. Partial response is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Complete response is defined as disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to <10 mm.
| Up to 33 months |
| Time to Discontinuation (TTD) | TTD is defined as the time from starting treatment to the time to treatment discontinuation due to any cause. | Up to 33 months |
| Poznan |
| Greater Poland Voivodeship |
| 60-355 |
| Poland |
| Wielkopolskie Centrum Pulmonologii i Torakochirurgii w Poznaniu | Poznan | Greater Poland Voivodeship | 60-569 | Poland |
| Centrum Onkologii im.Prof. F. Lukaszczyka w Bydgoszczy | Bydgoszcz | Kuyavian-Pomeranian Voivodeship | 85-796 | Poland |
| Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie- Panstwowy Instytut Badawczy Oddzial w Krakowie | Krakow | Lesser Poland Voivodeship | 31-115 | Poland |
| Krakowski Szpital Specjalistyczny im. Jana Pawla II w Krakowie | Krakow | Lesser Poland Voivodeship | 31-202 | Poland |
| Samodzielny Publiczny Szpital Kliniczny nr 4 w Lublinie | Lublin | Lublin Voivodeship | 20-954 | Poland |
| Instytut Gruzlicy i Chorob Pluc | Warsaw | Masovian Voivodeship | 01-138 | Poland |
| Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie, Panstwowy Instytut Badawczy | Warsaw | Masovian Voivodeship | 02-781 | Poland |
| Podkarpackie Centrum Chorob Pluc | Rzeszów | Podkarpackie Voivodeship | 35-241 | Poland |
| Centrum Pulmonologii i Torakochirurgii w Bystrej | Bystra | Slskie | 43-360 | Poland |
| SPZOZ Uniwersytecki Szpital Kliniczny nr 2 im. Wojskowej Akademii Medycznej Uniwersytetu Medycznego w Lodzi Centralny Szpital Weteranow | Lodz | Łódź Voivodeship | 90-549 | Poland |
| 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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