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This is an observational, non-interventional, retrospective, multicentre and nationwide study. The information will be obtained retrospectively, in most cases when the treatment has already ended.
The primary objective of this study is determine the activity of lorlatinib (percentage of responses, duration of response, progression-free survival and time to treatment failure) of patients included in the compassionate use program in Spain.
This is an observational, non-interventional, retrospective, multicentre and nationwide study. The information will be obtained retrospectively, in most cases when the treatment has already ended. In cases where the patient continues on the treatment, the researcher will not modify the clinical management of the patient by participating in the study.
Patients with metastatic non-small cell lung cancer treated with lorlatinib who were included in the compassionate use program in Spain between November 2016 and February 2019 for those with an ALK alteration, and between November 2016 to March 2021 for those with ROS1 alteration. According to the records of the Spanish centres participating in this program, approximately 145 patients have been included.
The primary objective of this study is determine the activity of lorlatinib (percentage of responses, duration of response, progression-free survival and time to treatment failure) of patients included in the compassionate use program in Spain.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental : Lorlatinib inn ALK Or ROS1 Metastatic NSCLC patient | Patients with metastatic non-small cell lung cancer treated with lorlatinib who were included in the compassionate use program in Spain between November 2016 and February 2019 for those with an ALK alteration, and between November 2016 to March 2021 for those with ROS1 alteration. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lorlatinib | Drug | No treatment will be administered to the patient as an active treatment of this study. Only retrospective data about the patients treated in the compassion use program of Lorlatinib will be collected. The information below is related to Lorlatinib, target drug for the collection of data. Lorviqua 25 mg film-coated tablets.The recommended dose is 100 mg lorlatinib taken orally once daily. Treatment with lorlatinib is recommended as long as the patient is deriving clinical benefit from therapy without unacceptable toxicity. Dosing interruption or dose reduction may be required based on individual safety and tolerability.Lorlatinib should be permanently discontinued if the patient is unable to tolerate the 50 mg dose taken orally once daily. |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival | Progression-free survival defined as time from the first dose of lorlatinib to the first documentation of progression or death from any cause. | From date of the first dose of lorlatinib treatment until the date of last follow up or death, assessed up to 60 months |
| Duration of the response | Duration of the response defined from the first documentation of tumor response to the first documentation of tumor progression or death from any cause. | From date of the first dose of lorlatinib treatment until the date of last follow up or death, assessed up to 60 months |
| Time to treatment failure | Time to treatment failure defined as time from the first dose of lorlatinib to the moment of discontinuation of treatment for any cause, including tumor progression, toxicity or death | From date of the first dose of lorlatinib treatment until the date of last follow up or death, assessed up to 60 months |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival of ALK and ROS1 NSCLC patients | Overall survival of ALK and ROS1 NSCLC patients from lorlatinib defined as time from the start of treatment until death or last follow-up | From date of the first dose of lorlatinib treatment until the date of last follow up or death, assessed up to 60 months |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with metastatic non-small cell lung cancer treated with lorlatinib who were included in the compassionate use program in Spain between November 2016 and February 2019 for those with an ALK alteration, and between November 2016 to March 2021 for those with ROS1 alteration. According to the records of the Spanish centres participating in this program, approximately 145 patients have been included.
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| Name | Affiliation | Role |
|---|---|---|
| Antonio Calles, MD | Fundación GECP Investigator | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Clínico Santiago | Santiago de Compostela | A Coruña | 15706 | Spain | ||
| Hospital Germans Trias i Pujol |
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| Label | URL |
|---|---|
| Web page of the sponsor where users can find more information about Fundacion GECP studies | View source |
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|
|
| Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability) |
Occurrence and severity of adverse events, with severity determined by NCI CTCAE v5.0 criteria. |
| From date of the first dose of lorlatinib treatment until the date of last follow up or death,assessed up to 60 months |
| Badalona |
| Barcelona |
| 08916 |
| Spain |
| Hospital Puerta del Mar | Cadiz | Cádiz | 11009 | Spain |
| Hospital Universitario Insular de Gran canaria | Las Palmas de Gran Canaria | Gran Canaria | 35016 | Spain |
| Complejo Hospitalario Universitario A Coruña | A Coruña | La Coruña | 15006 | Spain |
| Centro Oncológico de Galicia | A Coruña | La Coruña | 15009 | Spain |
| Hospital Universitario Central de Asturias | Oviedo | Principality of Asturias | 33011 | Spain |
| Hospital del Mar | Barcelona | 08003 | Spain |
| Hospital Universitari Quiron Dexeus | Barcelona | 08028 | Spain |
| Hospital Clinic de Barcelona | Barcelona | 08036 | Spain |
| Hospital Universitario de Burgos | Burgos | 09006 | Spain |
| Hospital Dr. Josep Trueta | Girona | 17007 | Spain |
| Hospital Universitario de Jaén | Jaén | 23007 | Spain |
| Complejo Asistencial Universitario de León | León | 24071 | Spain |
| Hospital Gregorio Marañón | Madrid | 28007 | Spain |
| Hospital Clínico San Carlos | Madrid | 28040 | Spain |
| Hospital 12 De Octubre | Madrid | 28041 | Spain |
| Hospital Puerta de Hierro | Madrid | 28222 | Spain |
| Hospital Fundación de Alcorcón | Madrid | 28922 | Spain |
| Hospital Virgen del Rocio | Seville | 41013 | Spain |
| Complejo Hospitalario de Toledo | Toledo | 45004 | Spain |
| Hospital Universitari i Politécnic La Fe | Valencia | 46009 | Spain |
| Hospital Clínico de Valencia | Valencia | 46010 | Spain |
| Hospital General de Valencia | Valencia | 46014 | Spain |
| Hospital Clínico Lozano Blesa | Zaragoza | 50009 | Spain |
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D008171 | Lung Diseases |
| D009362 | Neoplasm Metastasis |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D012140 | Respiratory Tract Diseases |
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C000590786 | lorlatinib |
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